U.S. patent application number 14/252273 was filed with the patent office on 2016-08-25 for electrical stimulation device and method for the treatment of neurological disorders.
The applicant listed for this patent is J. Chris Castel, Francis X. Palermo. Invention is credited to J. Chris Castel, Francis X. Palermo.
Application Number | 20160243354 14/252273 |
Document ID | / |
Family ID | 39716801 |
Filed Date | 2016-08-25 |
United States Patent
Application |
20160243354 |
Kind Code |
A9 |
Palermo; Francis X. ; et
al. |
August 25, 2016 |
ELECTRICAL STIMULATION DEVICE AND METHOD FOR THE TREATMENT OF
NEUROLOGICAL DISORDERS
Abstract
An electrical stimulation system and method for the treatment of
neurological disorders is disclosed. In a preferred embodiment, the
electrical stimulation system includes channels of electrodes
positioned in electrical contact with tissue of a neuromuscular
target body region of a patient to provide pattered neuromuscular
stimulation to the patient's musculature. In addition, at least one
electrode from a channel is positioned in electrical contact with a
tissue of the motor control region of the brain. A series of
patterned electrical pulses are then applied to the patient through
the channels to provide peripheral neuromuscular stimulation, and a
direct current is applied transcranially to the brain. Various
exemplary embodiments of the invention are disclosed.
Inventors: |
Palermo; Francis X.; (Reno,
NV) ; Castel; J. Chris; (Reno, NV) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Palermo; Francis X.
Castel; J. Chris |
Reno
Reno |
NV
NV |
US
US |
|
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20150290457 A1 |
October 15, 2015 |
|
|
Family ID: |
39716801 |
Appl. No.: |
14/252273 |
Filed: |
April 14, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13113389 |
May 23, 2011 |
8738142 |
|
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14252273 |
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11711285 |
Feb 27, 2007 |
7949403 |
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13113389 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/0452 20130101;
A61N 1/323 20130101; A61N 1/0492 20130101; A61N 1/20 20130101; A61N
1/0456 20130101; A61N 1/36025 20130101; A61N 1/0476 20130101; A61N
1/36146 20130101; A61N 1/36003 20130101; A61N 1/0526 20130101; A61N
1/0531 20130101; A61N 1/0548 20130101 |
International
Class: |
A61N 1/32 20060101
A61N001/32; A61N 1/20 20060101 A61N001/20; A61N 1/36 20060101
A61N001/36 |
Claims
1-22. (canceled)
23. An electrical stimulation system for treating neurological
disorders in a patient, said electrical stimulation system
comprising: at least first, second, and third channels of
electrodes, and an electronic control unit connected to said first
and second channels of electrodes and programmed to apply a pulse
train pattern selected from the group consisting of a plurality of
cycles of a biphasic sequential pulse train pattern, and a biphasic
overlapping pulse train pattern, a functional pulse train pattern,
a low-frequency pulse train pattern, and a frequency-sequenced
pulse burst train pattern to said first and second channels of
electrodes in accordance with a procedure for treating said
neurological disorder; and an electronic control unit connected to
said third channel of electrodes and programmed to apply a
transcranial direct current in accordance with a procedure for
treating said neurological disorder.
24. The electrical stimulation system of claim 1, wherein said
biphasic sequential pulse train pattern comprises a first phase of
electrical pulses applied to said first channel and a second phase
of electrical pulses applied to said second channel, wherein said
second phase of electrical pulses commences after termination of
said first phase of electrical pulses.
25. The electrical stimulation system of claim 1, wherein said
biphasic overlapping pulse train pattern comprises a first phase of
electrical pulses applied to said first channel and a second phase
of electrical pulses applied to said second channel, wherein said
second phase of electrical pulses commences before termination of
said first phase of electrical pulses.
26. The electrical stimulation system of claim 1, wherein said
first channel comprises a first positive electrode adapted to be
positioned in electrical contact with tissue of a first target body
region of said patient and a first negative electrode adapted to be
positioned in electrical contact with tissue of a second target
body region of said patient, and wherein said second channel
comprises a second positive electrode adapted to be positioned in
electrical contact with a tissue of a third target body region of
said patient and a second negative electrode adapted to be
positioned in electrical contact with a tissue of a fourth target
body region of said patient, and wherein said third channel
comprises a third positive electrode adapted to be in transcranial
electrical contact with a motor control region of said patient and
a third negative electrode adapted to be in electrical contact with
a tissue region contralateral to said motor control region or a
neutral region of said patient.
27. The electrical stimulation system of claim 4 wherein said third
negative electrode is larger in size than said third positive
electrode.
28. The electrical stimulation system of claim 1 wherein said
transcranial direct current is selected from the group consisting
of constant, pulsed, modulated, or interferential current.
29. The electrical stimulation system of claim 1 wherein said
electronic control unit connected to said first and second channels
and said electronic control unit connected to said third channel
are the same electronic control unit.
30. The electrical stimulation system of claim 1 wherein said
electronic control unit connected to said third channel of
electrodes is programmed to apply a transcranial direct current
comprising a continuous or pulsed direct current with electrical
pulses having a pulse duration of between 0.5 microseconds and 10
minutes.
31. The electrical stimulation system of claim 1 wherein said
electronic control unit connected to said third channel of
electrodes is programmed to apply a transcranial direct current to
about 4 milliamps or less.
32. The electrical stimulation system of claim 1 wherein said
electronic control unit connected to said third channel electrodes
is programmed to apply a transcranial direct current having a
current less than 10 mA, a pulse duration between 0.5 microsecond
to 10 microseconds, and a pulse frequency up 1 MHZ.
33. The electrical stimulation system of claim 1 wherein said
electronic control unit connected to said first and second channels
of electrodes is programmed to apply said pulse train pattern in
which electrical pulses in the pattern have a pulse duration
between 30 microseconds and 400 microseconds.
34. The electrical stimulation system of claim 1 wherein said
electronic control unit connected to said first and second channels
of electrodes is programmed to apply said pulse train pattern in
which electrical pulses in the pattern have a current amplitude
between 25 milliamps and 140 milliamps.
35. The electrical stimulation system of claim 1 wherein said
electronic control unit connected to said first and second channels
of electrodes is programmed to apply said pulse train pattern in
which electrical pulses in the pattern having frequency between 4
Hz and 200 Hz and a current of no more than 1 milliamp.
36. The electrical stimulation system of claim 1 wherein said
electronic control unit connected to said first and second channels
of electrodes is programmed to apply a low frequency pulse train
pattern comprising individual electrical pulses generated at a
frequency of between 4 Hz and 200 Hz.
37. The electrical stimulation system of claim 1 wherein said
electronic control unit connected to said first and second channels
of electrodes is programmed to apply a frequency-sequenced pulse
burst train pattern with a carrier frequency between 500 Hz and
100,000 Hz.
38. The electrical stimulation system of claim 1 wherein said
electronic control unit connected to said first and second channels
of electrodes is programmed to apply a frequency-sequenced pulse
burst train pattern comprising a first sequence of modulated
electrical pulses generated at a burst frequency of between 0.1 Hz
and 5 Hz, a second sequence of modulated electrical pulses
generated at a burst frequency of between 5 Hz and 20 Hz, and a
third sequence of modulated electrical pulses generated at a burst
frequency of between 20 Hz and 250 Hz.
39. The electrical stimulation system of claim 1 wherein said
electronic control unit connected to said first and second channels
of electrodes is programmed to apply a frequency-sequenced pulse
burst train pattern comprising a first sequence of modulated
electrical pulses generated at a burst frequency of between 5 Hz
and 20 Hz a second sequence of modulated electrical pulses
generated at a burst frequency of between 0.1 Hz and 5 Hz. and a
third sequence of modulated electrical pulses generated at a burst
frequency of between 20 Hz and 250 Hz.
40. The electrical stimulation system of claim 1 wherein said
electronic control unit connected to said first and second channels
of electrodes is programmed to apply a frequency-sequenced pulse
burst train pattern comprising a first sequence of modulated
electrical pulses generated at a burst frequency of between 20 Hz
and 250 Hz, and a second sequence of modulated electrical pulses
generated at a burst frequency of between 0.1 Hz and 5 Hz.
41. The electrical stimulation system of claim 1, wherein said
electronic control unit connected to said first and second channels
of electrodes is programmed to apply a biphasic overlapping pulse
train pattern comprising a first phase of electrical pulses applied
to said first channel of 60 milliseconds to 120 milliseconds, and a
second phase of electrical pulses applied to said second channel of
60 milliseconds to 120 milliseconds. wherein said second phase of
electrical pulses commences before termination of said first phase
of electrical pulses.
42. The electrical stimulation system of claim 19, wherein said
electronic control unit connected to said first and second channels
of electrodes is programmed to apply a biphasic overlapping pulse
train pattern wherein the individual electrical pulses in each
phase are approximately 30 Hz to 100 Hz.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional application of U.S. patent
application Ser. No. 11/711,285, filed on Feb. 27, 2007, which is
hereby incorporated herein by reference.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] Not applicable.
FIELD OF THE INVENTION
[0003] The present invention is generally directed to the treatment
of neurological disorders, and is more specifically directed to an
electrical stimulation device and method for applying electrical
stimulation, preferably pattered electrical pulses, to one or more
channels of electrodes or bifurcated electrodes in accordance with
a procedure for treating the neurological disorder along with
transcranial electrical stimulation of the brain.
DESCRIPTION OF RELATED ART
[0004] There are multiple forms of surface and percutaneous
neuromuscular electrical stimulation available for treatment of
neurological conditions. One form is patterned neuromuscular
stimulation that attempts to replicate the activation patterns of
nerves, muscles and the central nervous system including the spine
and the brain. These patterns can be created by a plurality of
energy input configurations that ultimately produce muscle and
nerve activation. The above devices typically produce transient or
brief activation bursts which are repeated for a longer period of
time.
[0005] Direct current stimulation has been shown to be well
tolerated in applications to the brain through the skull or
cranium. It is described as transcranial direct current stimulation
and is accomplished by multiple devices that generate continuous
low current ion flow through the skull into the brain tissue. Other
forms of brain stimulation involve creating holes in the skull and
implanting a variety of energy transmitters.
BRIEF SUMMARY OF THE INVENTION
[0006] The present invention is directed to an electrical
stimulation system and method for the treatment of neurological
disorders. The system combines both neuromuscular electrical
stimulation to target body regions and transcranial direct current
stimulation in a single treatment regime.
[0007] In one aspect, the electrical stimulation system comprises
(1) a neuromuscular stimulator adapted to stimulate the sensory and
motor nerves of the patient's musculature, such as the muscles of
the face, trunk, lower extremities, or upper extremities of the
patient combined with (2) a transcranial stimulator adapted to
stimulate the regions of the brain associated with sensation and
motor control of the patient's musculature. The neuromuscular
stimulator and the transcranial stimulator may be contained in a
single device or may be separate devices operated by one or more
electronic control units.
[0008] In another aspect, the electrical stimulation system
comprises a neuromuscular simulator having at least one electronic
control unit connected to channels of electrodes, such as
transcutaneous or percutaneous electrodes. Each channel comprises
two electrodes (i.e., a relative positive electrode and a relative
negative electrode). The electrodes of a first channel are
positioned in electrical contact with tissue of a target region of
the patient to stimulate one or more muscles associated with or
afflicted by a neurological disorder. The electrodes of a second
channel are positioned in electrical contact with tissue that is
also associated with or afflicted by the neurological disorder. In
many instances, the electrodes of the first and second channels are
positioned bilaterally or in electrical contact with the tissue of
agonist/antagonist pairs of muscles of the patient. The electronic
control unit applies a series of patterned electrical pulses to the
patient through the channels of electrodes in accordance with a
procedure for treating the neurological disorder.
[0009] In addition, the electrical stimulation system comprises
electrodes of a third channel and optional fourth channel
positioned in electrical contact with the patient's cranium. The
electronic control unit (or an electronic control unit in a
separate device) applies a transcranial direct current to select
areas of the patient's brain through the electrodes in accordance
with a procedure for treating the neurological disorder. Typically,
the positive electrodes of the third channel and optional fourth
channel are placed over the brain region associated with control of
the target muscles (e.g. the facial muscles, lower extremities,
upper extremities, trunk, etc.) and related brain sensory region,
and the negative electrode of the third and optional fourth channel
may be placed in a neutral position. For example, the negative
electrode may be placed contralaterally over the brain region
associated with control of the target muscles(s) on the opposite
side of the cranium, which may result in inhibition (not
stimulation) of that brain region. Alternatively, the negative
electrode may be placed on the prefrontal cortex (i.e., the
forehead) or on the patient's opposite shoulder/neck region as the
neutral position.
[0010] The electrical stimulation system of the present invention
is well adapted to rehabilitate and treat the motor control of the
major muscles the body, including but not limited to the major
muscles of the face, neck, shoulder, back, trunk, arm, forearm,
wrist, hand, hip, thigh, lower leg, ankle, and foot.
[0011] In a further aspect, the electrical stimulation system and
method of the present invention may be used to enhance performance
in otherwise normal or uninjured individuals, thus for example to
enhance athletic performance.
[0012] In yet another aspect, the patient's musculature and brain
motor-sensory regions are preferably stimulated in a manner that
facilitates movement of the target muscles with limited or no pain
in the patient.
[0013] Typically, the patient is treated with the electrical
simulation system for between ten minutes and two hours, most
preferably between 20 minutes and one hour, and still more
preferably for about 20 to 40 minutes. Treatment sessions can be
repeated as needed.
[0014] In one aspect, the neuromuscular patterned stimulation is
performed at the same time that the transcranial direct current
stimulation is performed on the patient. In another aspect, the
method of treatment comprises an initial period of transcranial
direct current stimulation only, typically 5, 10, 15, 20, or 30
minutes of constant or pulsed direct current stimulation, followed
by simultaneous neuromuscular stimulation and transcranial direct
current stimulation. In yet a further aspect, method of treatment
comprises an initial period of neuromuscular stimulation only,
typically 5, 10, 15, 20, or 30 minutes, followed by simultaneous
neuromuscular stimulation and transcranial direct current
stimulation.
[0015] It is envisioned that the transcranial direct current
stimulation lowers the threshold of brain activation and will
permit peripheral stimulation to be more effective in the
functional reorganization of the brain and its response to stimuli
from peripheral activation. Peripheral stimulation activates
muscles and nerves. These peripheral nerves send sensory
information back to the brain's somatosensory motor centers,
activating central patterns or circuit reflexes in the brain.
[0016] Patterned Electrical Neuromuscular Stimulation ("PENS")
[0017] As discussed above, the present invention is directed to an
electrical stimulation system and method which comprises a
neuromuscular stimulator having a plurality of channels adapted to
stimulate the motor and sensory nerves of the patient's
musculature, such as the muscles of the face, trunk, lower
extremities, or upper extremities of the patient.
[0018] The series of electrical pulses (which can be created from a
variety of pulse or wave generators) applied to the channels may
comprise a variety of different types of pulse train patterns. For
example, a plurality of cycles of a biphasic sequential or
overlapping pulse train pattern may be used, in which a first phase
of electrical pulses is applied to a first channel of electrodes
and a second phase of electrical pulses is applied to a second
channel of electrodes. Using the biphasic sequential pulse train
pattern, the second phase of electrical pulses commences after
termination of the first phase of electrical pulses such that there
is a time delay therebetween. Using the biphasic overlapping pulse
train pattern, the second phase of electrical pulses commences
simultaneous with or before termination of the first phase of
electrical pulses such that there is an overlap therebetween.
[0019] In another example, a plurality of cycles of a triphasic
sequential or overlapping pulse train pattern may be used, in which
a first phase of electrical pulses is applied to a first channel of
electrodes, a second phase of electrical pulses is applied to a
second channel of electrodes, and a third phase of electrical
pulses is applied to the first channel of electrodes. Using the
triphasic sequential pulse train pattern, the second phase of
electrical pulses commences after termination of the first phase of
electrical pulses such that there is a time delay therebetween and,
similarly, the third phase of electrical pulses commences after
termination of the second phase of electrical pulses such that
there is a time delay therebetween. Using the triphasic overlapping
pulse train pattern, the second phase of electrical pulses
commences simultaneous with or before termination of the first
phase of electrical pulses such that there is an overlap
therebetween and, similarly, the third phase of electrical pulses
commences before termination of the second phase of electrical
pulses such that there is an overlap therebetween. Furthermore, the
biphasic or triphasic pulse train patterns can be coupled or paired
together, creating four, five, or six phases grouped together.
[0020] In yet another example, the series of electrical pulses
comprises a functional pulse train pattern applied to one or more
channels of electrodes. In this example, the pulse train pattern
attempts to mimic the electrical sequencing of particular muscles
involved during normal functioning activity. Examples would
include, but are not limited to, the dorsiflexion and eversion of
the ankle typically accomplished during walking; extending,
flexing, and opposing the fingers to assist in gripping or holding
objects.
[0021] In a further example, the series of electrical pulses
comprises a low-frequency pulse train pattern applied to one or
more channels of electrodes, wherein the individual electrical
pulses are generated at a frequency of between 4 Hz and 200 Hz to
selectively generate the relative selective production
neurotransmitters and modulators (endorphins, dynorphins,
enkephalin, and serotonin, etc.) based on the frequency selected.
Stimulation at specific frequencies is believed to have beneficial
effects in the treatment of the neurological disorders due to the
normalization of hyperactive sensory centers (which play a role in
the re-education of the central pattern generators) or triggering
descending inhibition to reduce overactive muscle tone and/or
spasticity. The use of a single frequency of stimulation may be
most effective in targeting a single mechanism of inhibition that
may be dysfunctional.
[0022] Alternatively, a frequency-sequenced pulse burst train
pattern may be applied to one or more channels of electrodes,
wherein different sequences of modulated electrical pulses are
generated at different burst frequencies. Preferably, the different
burst frequencies are selected so as to generate the simultaneous
production of endorphins, dynorphins, enkephalin, and serotonin
during each of the respective sequences, which is believed to have
beneficial effects in the treatment of neurological disorders due
to the normalization of hyperactive sensory inputs (which play a
role in the re-education of the central pattern generators) or
triggering descending inhibition to reduce overactive muscle tone
and/or spasticity. The combined effect of the generation of
multiple inhibitory or excitatory neurotransmitters may provide a
more powerful effect than a single neurotransmitter for use in more
difficult cases or as a more generalized approach as compared to
the single frequency method.
[0023] Transcranial Direct Current Stimulation
[0024] As discussed above, the present invention is directed to an
electrical stimulation system and method which comprises a
transcranial direct current stimulator having a one or more
channels of electrodes adapted to stimulate the somatosensory and
motor control regions of the brain.
[0025] The transcranial direct current stimulation may be constant,
pulsed, modulated, or interferential. In one aspect, the direct
current is a constant current or constant voltage or combination
thereof. In another aspect, the direct current comprises a series
of electrical pulses at a mid-frequency pattern applied to one or
more channels of electrodes, wherein the individual electrical
pulses are generated at a carrier frequency. The stimulation may be
a constant current, constant voltage, or combination thereof. In
still another aspect, the direct current is a frequency-sequenced
pulse burst train pattern, wherein different sequences of modulated
electrical pulses are generated at different burst frequencies.
[0026] In one aspect, the transcranial direct current stimulation
is applied before the neuromuscular patterned electrical
stimulation as a pre-conditioning step. The preconditioning step
usually lasts for less than 500 milliseconds, and preferably less
than 300 milliseconds, prior to the activation of the first channel
of peripheral stimulation.
[0027] The electrical stimulation methods of the present invention
may also be combined with the administration of therapeutically
effective amounts of various pharmaceuticals useful for treating
neurological disorders, such as dopamine uptake inhibitors,
norepinephrine reuptake inhibitors, selective serotonin reuptake
inhibitors, monoamine oxidase inhibitors, serotonin and
noradrenaline reuptake inhibitors, norepinephrine uptake
inhibitors, dopamine agonists, acetocholinesterase inhibitors,
catechol O-methyltransferase inhibitors, and anticholinergic
agents. Antioxidants can also be used with other neuroprotective
agents as adjuncts to transcranial stimulation.
BRIEF DESCRIPTION OF THE DRAWINGS
[0028] The present invention will be described in greater detail in
the following detailed description of the invention with reference
to the accompanying drawings that form a part hereof, in which:
[0029] FIG. 1A is a block diagram of a neuromuscular electrical
stimulation device that may be used in accordance with the
electrical stimulation system and method of the present
invention.
[0030] FIG. 1B is a block diagram of a transcranial direct current
electrical stimulation device that may be used in accordance with
the electrical stimulation system and method of the present
invention.
[0031] FIG. 2A is a timing diagram of a biphasic sequential pulse
train pattern that may be applied to the output channels of the
neuromuscular electrical stimulation device of FIG. 1.
[0032] FIG. 2B is a timing diagram of a biphasic overlapping pulse
train pattern that may be applied to the output channels of the
neuromuscular electrical stimulation device of FIG. 1.
[0033] FIG. 2C is a timing diagram of a triphasic sequential pulse
train pattern that may be applied to the output channels of the
neuromuscular electrical stimulation device of FIG. 1.
[0034] FIG. 2D is a timing diagram of a triphasic overlapping pulse
train pattern that may be applied to the output channels of the
neuromuscular electrical stimulation device of FIG. 1.
[0035] FIG. 2E is a timing diagram of a low-frequency pulse train
pattern that may be applied to the output channels of the
neuromuscular electrical stimulation device of FIG. 1.
[0036] FIG. 2F is a timing diagram of a first frequency-sequenced
pulse burst train pattern that may be applied to the output
channels of the neuromuscular electrical stimulation device of FIG.
1.
[0037] FIG. 2G is a timing diagram of a second frequency-sequenced
pulse burst train pattern that may be applied to the output
channels of the neuromuscular electrical stimulation device of FIG.
1.
[0038] FIG. 2H is a timing diagram of a third frequency-sequenced
pulse burst train pattern that may be applied to the output
channels of the neuromuscular electrical stimulation device of FIG.
1.
[0039] FIG. 3A illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with a first exemplary embodiment of the
present invention, in which the facial muscles (e.g. the masseter
and/or pterygoid and buccinator and/or orbicularis oris muscles) of
the patient are stimulated. The neuromuscular electrical
stimulation is combined with transcranial direct current electrical
stimulation as generally illustrated in FIG. 4.
[0040] FIG. 3B illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with a second exemplary embodiment of the
present invention, in which the facial muscles (e.g. the buccinator
and/or orbicularis oris and masseter muscles) and the tongue and/or
pharynx of the patient are stimulated. The neuromuscular electrical
stimulation is combined with transcranial direct current electrical
stimulation as generally illustrated in FIG. 4.
[0041] FIG. 3C (top panel) illustrates a method for treating a
neurological disorder in a patient by applying neuromuscular
electrical stimulation in accordance with a second exemplary
embodiment of the present invention, in which the facial muscles
(e.g., the buccinator and/or orbicularis oris muscles) and the
cervical paraspinal muscles of the patient are stimulated. The
neuromuscular electrical stimulation is combined with transcranial
direct current electrical stimulation as generally illustrated in
FIG. 4.
[0042] FIG. 3C (lower panel) illustrates a method for treating a
neurological disorder in a patient by applying neuromuscular
electrical stimulation in accordance with a third exemplary
embodiment of the present invention, in which the facial muscles
(e.g. masseter and/or pterygoid muscles) and the cervical
paraspinal muscles of the patient are stimulated. The neuromuscular
electrical stimulation is combined with transcranial direct current
electrical stimulation as generally illustrated in FIG. 4.
[0043] FIG. 3D illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with a fourth exemplary embodiment of the
present invention, in which the trapezius muscles and the cervical
paraspinal muscles of the patient are stimulated. The neuromuscular
electrical stimulation is combined with transcranial direct current
electrical stimulation as generally illustrated in FIG. 4.
[0044] FIG. 3E illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with a fifth exemplary embodiment of the
present invention, in which the cervical paraspinal and thoracic
paraspinal muscles of the patient are stimulated. The neuromuscular
electrical stimulation is combined with transcranial direct current
electrical stimulation as generally illustrated in FIG. 4.
[0045] FIG. 3F illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with a sixth exemplary embodiment of the
present invention, in which the lower cervical/upper thoracic
paraspinal and mid to lower thoracic paraspinal muscles of the
patient are stimulated. The neuromuscular electrical stimulation is
combined with transcranial direct current electrical stimulation as
generally illustrated in FIG. 4.
[0046] FIG. 3G illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with a seventh exemplary embodiment of
the present invention, in which the lumbar paraspinal muscles and
abdominal muscles of the patient are stimulated. The neuromuscular
electrical stimulation is combined with transcranial direct current
electrical stimulation as generally illustrated in FIG. 4. This
embodiment is particularly useful in promoting lumbar stabilization
in a patient.
[0047] FIG. 3H illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with an eighth exemplary embodiment of
the present invention, in which the thoracic and/or lumbar
paraspinal muscles and abdominal muscles of the patient are
stimulated. The neuromuscular electrical stimulation is combined
with transcranial direct current electrical stimulation as
generally illustrated in FIG. 4. This embodiment is particularly
useful in promoting trunk flexion/extension in a patient.
[0048] FIG. 3I illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with a ninth exemplary embodiment of the
present invention, in which the biceps brachii and triceps brachii
muscles of the patient are stimulated. The neuromuscular electrical
stimulation is combined with transcranial direct current electrical
stimulation as generally illustrated in FIG. 4. This embodiment is
particularly useful in promoting arm flexion/extension in a
patient.
[0049] FIG. 3J illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with a tenth exemplary embodiment of the
present invention, in which the muscles associated with shoulder
internal and external rotation are stimulated. The neuromuscular
electrical stimulation is combined with transcranial direct current
electrical stimulation as generally illustrated in FIG. 4.
[0050] FIG. 3K illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with an eleventh exemplary embodiment of
the present invention, in which the muscles associated with
shoulder flexion and extension are stimulated. The neuromuscular
electrical stimulation is combined with transcranial direct current
electrical stimulation as generally illustrated in FIG. 4.
[0051] FIG. 3L illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with a twelfth exemplary embodiment of
the present invention, in which the muscles associated with wrist
and finger flexion and extension are stimulated. The neuromuscular
electrical stimulation is combined with transcranial direct current
electrical stimulation as generally illustrated in FIG. 4.
[0052] FIG. 3M illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with a thirteenth exemplary embodiment of
the present invention, in which the muscles associated with upper
extremity motor control are stimulated. The neuromuscular
electrical stimulation is combined with transcranial direct current
electrical stimulation as generally illustrated in FIG. 4.
[0053] FIG. 3N illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with a fourteenth exemplary embodiment of
the present invention, in which the triceps brachii muscles are
stimulated during a physical activity, such as cycling. The
neuromuscular electrical stimulation is combined with transcranial
direct current electrical stimulation as generally illustrated in
FIG. 4.
[0054] FIG. 3O illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with a fifteenth exemplary embodiment of
the present invention, in which the muscles associated with
scapular abduction and upward rotation are stimulated. The
neuromuscular electrical stimulation is combined with transcranial
direct current electrical stimulation as generally illustrated in
FIG. 4.
[0055] FIG. 3P illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with a sixteenth exemplary embodiment of
the present invention, in which the muscles of the upper extremity
are stimulated, such as the first dorsal interosseous or hand
intrinsic muscles, the muscles in proximity to the elbow (such as
the extensor carpi radialis longus and brevis at their origin near
the elbow, including the radial nerve), the posterior shoulder
muscles, and the cervical paraspinal muscles are stimulated. The
neuromuscular electrical stimulation is combined with transcranial
direct current electrical stimulation as generally illustrated in
FIG. 4.
[0056] FIG. 3Q illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with a seventeenth exemplary embodiment
of the present invention, in which the muscles of the lower
extremity are stimulated, including but not limited to the muscles
associated with the knee (e.g., vastus medialis muscle), leg (e.g.,
proximal anterior tibialis and distal peroneal muscles), and and/or
foot (e.g., extensor digitorum brevis muscle). The neuromuscular
electrical stimulation is combined with transcranial direct current
electrical stimulation as generally illustrated in FIG. 4.
[0057] FIG. 3R illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with an eighteenth exemplary embodiment
of the present invention, in which the muscles associated with toe
extension/flexion as well as inversion/eversion are stimulated. The
neuromuscular electrical stimulation is combined with transcranial
direct current electrical stimulation as generally illustrated in
FIG. 4.
[0058] FIG. 3S illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with a nineteenth exemplary embodiment of
the present invention, in which the muscles associated with ankle
dorsiflexion/eversion and plantar flexion/eversion are stimulated.
The neuromuscular electrical stimulation is combined with
transcranial direct current electrical stimulation as generally
illustrated in FIG. 4.
[0059] FIG. 3T illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with a twentieth exemplary embodiment of
the present invention, in which the muscles associated with
movement of the lower extremities are stimulated. The neuromuscular
electrical stimulation is combined with transcranial direct current
electrical stimulation as generally illustrated in FIG. 4.
[0060] FIG. 3U illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with a twenty-first exemplary embodiment
of the present invention, in which the muscles associated with hip
abduction/adduction/extension and knee extension/flexion are
stimulated. The neuromuscular electrical stimulation is combined
with transcranial direct current electrical stimulation as
generally illustrated in FIG. 4.
[0061] FIG. 3V illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with a twenty-second exemplary embodiment
of the present invention, in which the muscles associated with knee
flexion and extension are stimulated. The neuromuscular electrical
stimulation is combined with transcranial direct current electrical
stimulation as generally illustrated in FIG. 4.
[0062] FIG. 3W illustrates a method for treating a neurological
disorder in a patient by applying neuromuscular electrical
stimulation in accordance with a twenty-third exemplary embodiment
of the present invention, in which the muscles associated with
bilateral knee extension are stimulated. The neuromuscular
electrical stimulation is combined with transcranial direct current
electrical stimulation as generally illustrated in FIG. 4.
[0063] FIG. 4A illustrates a method for treating a neurological
disorder in a patient by applying transcranial direct current
electrical stimulation to the patient, in which the somatosensory
and motor control region of the facial musculature, lower extremity
musculature, or upper extremity musculature are stimulated. The top
panel is a lateral view of the patient, and the bottom panel is a
frontal view of the patient. The transcranial direct current
stimulation is combined with neuromuscular electrical stimulation
as generally illustrated in FIGS. 3A-3W.
[0064] FIGS. 4B-C illustrates three alternative electrode
placements for the transcranial stimulation shown in FIG. 4A. In
both FIGS. 4B and 4C, the positive electrode 118a is placed over
the somatosensory and motor control region of the brain associated
with the target muscle. In FIG. 4B, the negative electrode 118b is
then placed contralaterally to the positive electrode 118a, and in
FIG. 4C, the negative electrode is placed over the prefrontal
cortex or on the patient's neck or shoulder region.
[0065] FIG. 4D illustrates two alternative embodiments for
electrode placements for the bilateral transcranial direct current
stimulation of a patient. In FIG. 4D, the positive electrodes 118a
and 120a are placed contralaterally to each over the somatosensory
and motor control regions of the brain. The negative electrodes
118b and 120b are then placed contralaterally to each other on the
same side as their corresponding positive electrodes 118a, 120a
over the prefrontal cortex (top panel) or on the patient's shoulder
(bottom panel).
[0066] FIG. 4E illustrates two alternative embodiments for
electrode placements for the interferential transcranial direct
current stimulation of a patient. In FIG. 4E, the positive
electrodes 118a and 120a are placed contralaterally to each over
the same somatosensory and motor control regions of the brain. The
negative electrodes 118b and 120b are then placed contralaterally
to each other on the opposite side of the prefrontal cortex (top
panel) or the patient's shoulder (lower panel) compared to their
corresponding positive electrodes 118a, 120a.
[0067] In FIG. 4E, the electrodes are crossed to form an
interferential current. As each channel of direct or pulsed direct
current is electrically isolated from each other, when the
electrodes are placed in such a manner that the fields intersect,
new fields are created in the deep tissue from the summation of the
two or more fields. These fields are the vector sum of the two
fields and allow the signal to be steered to selective areas of the
deeper tissue in the brain that would not otherwise be accessible
from surface stimulation, such as the lower extremity somatosensory
and motor control sites. The polarity of the summation or vector
field in the deep brain tissue is dependent on the polarity of the
superficial electrode placement. This approach uniquely allows
stimulation or inhibition of deep brain structures based on the
polarity of the direct or pulsed direct current field. If the
pulsed direct current is of a sufficient frequency it can overcome
the tissue impedance and capacitively couple through the skull more
efficiently than a straight direct current field, although both
will cause summation vectors in the deep brain tissue.
[0068] FIG. 5 illustrates the timing diagram of the transcranial
direct current stimulation. In FIG. 5A, a constant direct current
is applied to the patient. In FIG. 5B, a repetitive monopolar pulse
train is applied at a suitable carrier frequency. FIG. 5C is a
timing diagram of a monopolar burst modulated pulse train pattern
that may be applied to the output channels of the transcranial
electrical stimulation device of FIG. 1B.
[0069] FIG. 6 is a timing diagram of an exemplary electrical
stimulation system in accordance with the present invention. The
top two panels illustrate an exemplary timing diagram for the
neuromuscular stimulation, while the bottom two panels illustrate
alternative exemplary timing diagrams for the transcranial direct
current stimulation.
DETAILED DESCRIPTION OF THE INVENTION
[0070] The present invention is directed to an electrical
stimulation system and method for the treatment of neurological
disorders.
[0071] As used herein, the term "administration" refers to a method
of giving an agent to a patient, where the method is, e.g.,
topical, oral, intravenous, transdermal, intraperitoneal, or
intramuscular. The preferred method of administration can vary
depending on various factors, e.g., the components of the
pharmaceutical composition.
[0072] As used herein, "concurrent administration,"
"co-administration," or "co-treatment" includes administration of
the agents together, or before or after each other. The therapeutic
agents co-administered with the electrical stimulation treatment
methods may be administered by the same or different routes.
[0073] As used herein, the term "electrical stimulation" refers to
the passing of various types of current to a patient through
transcutaneous or percutaneous electrodes, and includes indirect
nerve and/or muscle activation by stimulation of the nerves
innervating the sensor (cutaneous and position sensors) and muscle
fibers associated with central pattern generator inputs or
inhibitory mechanism and stimulation of motor efferent fibers which
activate the muscles in the target region.
[0074] Examples of the types of electrical stimulation that may be
used include, but are not limited to, Patterned Electrical
Neuromuscular Stimulation ("PENS"), Transcutaneous Electrical Nerve
Stimulation ("TENS"), Neuromuscular Electrical Stimulation
("NMES"), and Interferential Current ("IFC"), Percutaneous
Electrical Muscle Stimulation ("PEMS"), Percutaneous Electrical
Nerve Stimulation ("PENS"), pulsed magnetic field neuromuscular
depolarization systems, functional electrical stimulation ("FES"),
and electroacupuncture, which may use alternating or modulated
alternating current waveforms, asymmetrical or symmetrical biphasic
pulsed current waveforms, and monophasic pulsed current waveforms,
or sine wave modulation. Of course, one skilled in the art will
appreciate that other types of electrical stimulation may also be
used in accordance with the present invention.
[0075] As used herein, the term "direct current" refers to an
electric current which flows in one direction only through a
circuit or equipment creating a net ion flow. The term "direct
current" includes both constant (continuous) and pulsed
(interrupted) direct current. The associated direct current, in
contrast to alternating current, is of unchanging polarity. Direct
current corresponds to a drift or displacement of electric charge
in one unvarying direction around the closed loop or loops of an
electric circuit. The polarity may be reversed from time to time;
however, net ion flow must be created. Direct currents and voltages
may be of constant magnitude or may vary with time.
[0076] As used herein, the term "motor cortex" refers to the
primary motor cortex (or M1) and optionally the secondary motor
cortices, such as the posterior parietal cortex, the premotor
cortex, and the supplemental motor area.
[0077] As used herein, the term "somatosensory cortex" refers to
the lateral postcentral gyrus and is roughly the same as Brodmann
areas 3, 1, and 2.
[0078] As used herein, the term "motor point" refers to an area of
tissue that can be electrically stimulated by lower levels of
electricity compared to surrounding areas. The motor point overlies
the innervation zone of a muscle where the motor nerve endings are
concentrated or where the nerve trunk enters the muscle. The motor
point is often used as a placement site for surface electrodes used
to stimulate the muscle. In the following embodiments, motor points
of the muscles are preferably stimulated.
[0079] As used herein, the term "neurological disorder" refers to
strokes, traumatic brain injury, cerebral palsy, dystonias,
hydrocephalus, toxicity, inflammation, muscular dystrophies, motor
neuron diseases, inflammatory myopathies, neuromuscular junction
disorders, peripheral nerve disorders, as well as neurodegenerative
disorders such as, multiple sclerosis, Parkinson's disease and
other neurological conditions resulting in a reduction of motor
function. Examples of motor neuron diseases include, but are not
limited to, adult spinal muscular atrophy, amyotrophic lateral
sclerosis or Lou Gehrig's Disease, infantile progressive spinal
muscular atrophy or SMA Type 1 or Werdnig-Hoffman, intermediate
spinal muscular atrophy or SMA Type 2, juvenile spinal muscular
atrophy or SMA Type 3 or Kugelberg-Welander, spinal bulbar muscular
atrophy (SBMA) or Kennedy's Disease, or X-linked SBMA. Examples of
neuromuscular junction diseases include, but are not limited to,
myasthenia gravis, Lambert-Eaton Syndrome, and congenital
myasthenic syndrome. Examples of peripheral nerve disorders
include, but are not limited to, Charcot-Marie-Tooth Disease or
peroneal muscular atrophy, Dejerine-Sottas Disease, and
Friedreich's Ataxia. Other myopathies include myotonia congenita or
Thomsen's and Becker's Disease, paramyotonia congenita, central
core disease, periodic paralysis (PP) hypokalemic and hyperkalemic,
endocrine myopathies, and mitochondrial myopathies.
[0080] The term "stroke" refers to the multitude of subcategories
of cebrovascular diseases including thrombotic or embolic
infarction as well as intracerebral hemorrhage from a vascular or
post operative nature.
[0081] In a preferred aspect, the present invention is used in the
treatment of neurological disorders following stroke. Stroke is the
second most common cause of death and the leading cause of adult
disability in the United States today. 700,000 strokes occur each
year in the United Sates leaving 500,000 survivors with residual
disability. Forty percent of these survivors have moderate
impairment and functional limitation related to motor function and
basic mobility while 15-30% are severely disabled. Patients with
intact cortical function have an advantage when it comes to brain
plasticity during the functional reorganization that occurs
following stroke. Patients with hemorrhagic strokes or left
hemiparesis (right hemispheric lesion) are believed to have greater
motor impairment and poorer prognosis for recovery of motor
function than patients with ischemic strokes or right hemiparesis
(left hemispheric lesions).
[0082] As used herein, the term "neutral" in the context of an
electrode means that the stimulation at that region will not cause
a significant physical or neurological change. Typically, this
means than the region (e.g. the forehead, neck, or shoulder)
receives less than 0.015 amps per square centimeter of current.
[0083] The phrase "pharmaceutically acceptable" is employed herein
to refer to those compounds, materials, compositions, and/or dosage
forms which are, within the scope of sound medical judgment,
suitable for use in contact with the tissues of human beings and
animals without excessive toxicity, irritation, allergic response,
or other problem or complication, commensurate with a reasonable
benefit/risk ratio.
[0084] The phrase "therapeutically effective amount" as used
herein, means that amount of an active agent which, alone or in
combination with other drugs, provides a therapeutic benefit in the
prevention, treatment, or management a neurological disorder.
Different therapeutically effective amounts may be applicable for
each disorder, as will be readily known by those of ordinary skill
in the art.
[0085] As used herein, the term "tissue" refers to an aggregation
of morphologically similar cells and associated intercellular
matter acting together to perform one or more specific functions in
the body, including epithelial, connective, muscle, and neural
tissue.
[0086] As used herein, the term "treatment" refers to the treatment
of a neurological disorder in a patient, such as a mammal
(particularly a human), which includes preventing, ameliorating,
suppressing, or alleviating one ore more of the symptoms of the
neurological disorder.
[0087] As used herein, the term "agonist muscle" broadly refers to
a muscle that is resisted or counteracted by another muscle, the
"antagonist muscle." Examples of agonist/antagonist muscle pairs
include abductors/adductors, flexors/extensors,
supinators/pronators, protractors/retractors, and
evertors/invertors.
[0088] As used herein, the term "abductors" refers to muscles that
generally cause movement away from the body centerline while
"adductors" are muscles that generally cause movement toward the
body centerline.
[0089] As used herein, the term "flexors" refers to muscles that
generally reduce the angle of a joint, while the "extensors" reduce
the angle of the joint. For example, both the flexor carpi radialis
and flexor carpi ulnaris are both flexors of the wrist. The
extensor carpi radialis longus, in conjunction with extensor carpi
radialis brevis, is an extensor of the wrist.
[0090] As used herein, the term "pronator" refers to a muscle that
causes the movement of the wrist from the palm facing front to the
palm facing back. The opposing movement, which turns the palm
forward, is directed by a "supinator."
[0091] As used herein, the term "protractor" refers to a muscle
that moves a part of the body anteriorly in the horizontal plan
while a "retractor" is involved in the reverse movement.
[0092] As used herein, the term "evertor" refers to a muscle
involved in the twisting motion of the foot that turns the sole
outward while the opposite movement of turning the sole inward is
performed by an "inverter" muscle.
[0093] Referring to FIG. 1, an exemplary embodiment of an
electrical stimulation system that may be used in accordance with
the method of the present invention. The electrical stimulation
system comprises a neuromuscular stimulation device 10 and a
transcranial electrical stimulation device 100. It will be
appreciated to those skilled in the art that while the
neuromuscular simulation device 10 and transcranial electrical
stimulation device 100 may be combined in to a single device
operated by a single electronic control unit. However, for
simplicity, separate devices will be described herein.
[0094] Neuromuscular Stimulation Device
[0095] As shown in FIG. 1A, the neuromuscular stimulation device is
designated generally as reference numeral 10. The neuromuscular
electrical stimulation device 10 generally comprises an electronic
control unit 12 with a plurality of output connectors 14, 16, which
are connected to a plurality of output cables 18, 20 and associated
electrode pairs 18a, 18b, and 20a, 20b, respectively. Although two
output connectors 14, 16 are shown in FIG. 1A, it should be
understood that electronic control unit 12 may include any number
of output connectors (such as one, two, six, or eight output
connectors) in accordance with the present invention. In addition,
one or more of the cables may be bifurcated into multiple (e.g., 2,
3, 4, 5, or 6) electrodes.
[0096] Output cables 18, 20 each comprise any suitable type of
insulated conductive cable, such as a coaxial cable. In the
illustrated embodiment, output cable 18 includes a back section 22
with a connector 24 (such as a male jack) that attaches to output
connector 14, and a front section 26 that splits into a first split
end 26a and a second split end 26b. Similarly, output cable 20
includes a back section 28 with a connector 30 (such as a male
jack) that attaches to output connector 16, and a front section 32
that splits into a first split end 32a and a section split end 32b.
Of course, it should be understood that each of output cables 18,
20 could alternatively be manufactured out of two separate leads
(instead of having a front section with split ends). In addition,
output cables 18, 20 could be connected directly to electronic
control unit 12 without the use of connectors.
[0097] As can be seen in FIG. 1A, electrodes 18a, 18b are attached
to split ends 26a, 26b of output cable 18, respectively. Similarly,
electrodes 20a, 20b are attached to split ends 32a, 32b of output
cable 20, respectively. As such, output cable 18 and electrodes
18a, 18b together form a first output channel (referred to
hereinafter as "channel A"), and output cable 20 and electrodes
20a, 20b together form a second output channel (referred to
hereinafter as "channel B"). Although two channels are shown in
FIG. 1, it should be understood that any number of channels may be
used in accordance with the present invention (provided, of course,
that the number of channels corresponds to the number of output
connectors of electronic control unit 12).
[0098] In the illustrated example, electrodes 18a and 20a each
comprise a relative positive electrode, and electrodes 18b and 20b
each comprise a relative negative electrode. As will be described
in greater detail herein below, each of the electrical pulses
applied to electrodes 18a, 18b and electrodes 20a. 20b may
comprise, for example, a monophasic waveform (which has absolute
polarity), a biphasic asymmetric waveform (which has relative
polarity), or a biphasic symmetric waveform (which has no
polarity). Thus, as used herein, the term "positive electrode"
refers to a relative positive electrode and the term "negative
electrode" refers to a relative negative electrode (regardless of
whether the electrical pulse comprises a monophasic waveform, an
asymmetric biphasic waveform, or a symmetric biphasic waveform
(which behaves like the relative positive or relative negative
electrode during each phase of the waveform)).
[0099] Electrodes 18a, 18b and 20a, 20b are each adapted to be
positioned in electrical conduct with tissue of selected regions of
a patient, as will be described in greater detail herein below with
reference to FIGS. 3A-3W. In the illustrated embodiment, each of
electrodes 18a, 18b and 20a, 20b comprises a transcutaneous
electrode having a surface electrode pad that may be placed on the
skin of a patient. As is known in the art, each of electrodes 18a,
18b and 20a, 20b may be formed of metal or some other
physiologically acceptable conductive material and may take on a
variety of different sizes and shapes. Of course, one or more of
electrodes 18a, 18b and 20a, 20b may alternatively comprise a
percutaneous electrode, such as a needle electrode, or any other
type of suitable electrode in accordance with the present
invention.
[0100] Electronic control unit 12 also includes internal circuitry
(not shown) for selectively generating a series of electrical
pulses in accordance with a procedure for treating a neurological
disorder. The series of electrical pulses generated by the
circuitry are provided at output connectors 14, 16 and, as such,
may be applied to a patient through channel A and/or channel B. The
series of electrical pulses may comprise a variety of different
types of pulse train patterns, such as: a plurality of cycles of a
biphasic sequential pulse train pattern; a plurality of cycles of a
biphasic overlapping pulse train pattern; a plurality of cycles of
a triphasic sequential pulse train pattern; a plurality of cycles
of a triphasic overlapping pulse train pattern; a functional pulse
train pattern; a low-frequency pulse train pattern; or a
frequency-sequenced pulse burst train pattern. Each of these pulse
train patterns will be described in detail herein below with
reference to FIGS. 2A-2H. One skilled in the art will understand
that a variety of different circuit configurations may be used to
generate the various pulse train patterns, such as the circuitry
described in Palermo U.S. Pat. No. 5,562,718, which is incorporated
herein by reference.
[0101] A variety of different neuromuscular electrical stimulation
devices may be used and/or adapted for use in accordance with the
present invention. For example, one could easily incorporate the
protocols disclosed herein into the OMNISTIM.RTM. FX.sup.2
patterned electrical neuromuscular stimulator or the OMNISTIM.RTM.
FX.sup.2 Pro patterned electrical neuromuscular stimulator, both of
which are sold by the assignee of the present application. Of
course, other types of electrical stimulation devices could also be
used, which are generally available in the industry.
[0102] Referring now to FIGS. 2A-2H, examples of the various types
of pulse train patterns that may be used in accordance with the
present invention will now be described herein below. Each of the
pulse train patterns is comprised of a series of individual
electrical pulses arranged into a particular pattern. Each of the
electrical pulses may comprise either a monophasic or biphasic
waveform, which may be, for example, asymmetric, symmetric, square,
sinusoidal, overlapping sinusoidal (interferential), and the like.
Preferably, each of the electrical pulses comprises a biphasic
asymmetric square wave having a pulse duration that ranges between
30 microseconds and 400 microseconds (preferably less than 100
microseconds) during the positive and negative phases and a current
amplitude that typically ranges between 25 milliamps and 140
milliamps. It will be appreciated that the higher currents may be
tolerable (for example up to 200 milliamps) when the pulse width is
lowered.
[0103] It has been found that electrical pulses having a short
pulse duration and high current amplitude selectively trigger
p-type calcium channels (preferably having a pulse duration of
30-100 microseconds and a current amplitude of 25-140 milliamps).
Activation of p-type calcium channels will in turn trigger the
release of nerve growth factor ("NGF") to sustain axon regeneration
and repair. This repeated p-type calcium channel activation
increases the calcium pool at the neuromuscular junction, which
facilitates enhanced muscle recruitment. Twitch contractions may
increase in intensity during the treatment even though the
stimulation output is not increased as observed empirically. This
additional calcium at the neuromuscular junction lasts for several
hours post-treatment, which facilitates voluntary movement. See
Regeneron Corp. (Tarrytown, N.Y.) Neural stimulation effects
presentation, Society for Neuroscience, San Diego 1998 (short and
long term nerve growth potentiation using repetitive electric
stimulation).
[0104] Biphasic Sequential Pulse Train Pattern
[0105] Referring to FIG. 2A, electrical stimulation system 10 may
be used to apply a plurality of cycles of a biphasic sequential
pulse train pattern to a patient. In a typical biphasic sequential
pulse train pattern, a first phase of electrical pulses is applied
to channel A and a second phase of electrical pulses is applied to
channel B with a delay period therebetween.
[0106] In the illustrated example, the first phase of electrical
pulses is applied to channel A for approximately 60 milliseconds to
120 milliseconds (and most preferably for 100 milliseconds). At the
conclusion of the first phase of electrical pulses, there is a
delay period of approximately 0 milliseconds to 100 milliseconds
(and most preferably 80 milliseconds) before the second phase of
electrical pulses is applied to channel B. Then, the second phase
of electrical pulses is applied to channel B for approximately 60
milliseconds to 120 milliseconds (and most preferably for 100
milliseconds). The frequency of the individual electrical pulses in
each phase is approximately 30 Hz to 100 Hz (and most preferably 50
Hz).
[0107] The biphasic sequential pulse train pattern described above
may be repeated approximately every 0.33 seconds (3 Hz) to 3
seconds (0.33 Hz). Preferably, the pulse train pattern is applied
to the patient for a total treatment time of approximately 10
minutes to 30 minutes (and most preferably for 20 minutes), as
desired for a particular treatment.
[0108] Biphasic Overlapping Pulse Train Pattern
[0109] Referring to FIG. 2B, electrical stimulation system 10 may
also be used to apply a plurality of cycles of a biphasic
overlapping pulse train pattern to a patient. In a typical biphasic
overlapping pulse train pattern, a first phase of electrical pulses
is applied to channel A and a second phase of electrical pulses is
applied to channel B with an overlap period therebetween.
[0110] In the illustrated example, the first phase of electrical
pulses is applied to channel A for approximately 60 milliseconds to
120 milliseconds (and most preferably for 100 milliseconds). When
the first phase of electrical pulses has reached a time period of
between 40 milliseconds and 100 milliseconds (and most preferably
80 milliseconds), the second phase of electrical pulses is applied
to channel B for approximately 60 milliseconds to 120 milliseconds
(and most preferably for 100 milliseconds). Thus, there is an
overlap period of approximately 20 milliseconds to 80 milliseconds
(and most preferably 20 milliseconds) during which both channel A
and channel B are providing electrical stimulation to the patient.
The frequency of the individual electrical pulses in each phase is
approximately 30 Hz to 100 Hz (and most preferably 50 Hz).
[0111] The biphasic overlapping pulse train pattern described above
may be repeated approximately every 0.33 seconds (3 Hz) to 3
seconds (0.33 Hz). Preferably, the pulse train pattern is applied
to the patient for a total treatment time of approximately 10
minutes to 60 minutes (and Most preferably 20 minutes), as desired
for a particular treatment.
[0112] Triphasic Sequential Pulse Train Pattern
[0113] Referring to FIG. 2C, electrical stimulation system 10 may
also be used to apply a plurality of cycles of a triphasic
sequential pulse train pattern to a patient. In a typical triphasic
sequential pulse train pattern, a first phase of electrical pulses
is applied to channel A, a second phase of electrical pulses is
applied to channel B, and a third phase of electrical pulses is
applied to channel A, wherein there is a delay period between the
first and second phases of electrical pulses and another delay
period between the second and third phases of electrical
pulses.
[0114] In the illustrated example, the first phase of electrical
pulses is applied to channel A for approximately 60 milliseconds to
120 milliseconds (and most preferably for 100 milliseconds). At the
conclusion of the first phase of electrical pulses, there is a
delay period of approximately 0 milliseconds to 100 milliseconds
(and most preferably 80 milliseconds) before the second phase of
electrical pulses is applied to channel B. Then, the second phase
of electrical pulses is applied to channel B for approximately 60
milliseconds to 120 milliseconds (and most preferably for 100
milliseconds). At the conclusion of the second phase of electrical
pulses, there is a delay period of approximately 0 milliseconds to
100 milliseconds (and most preferably 80 milliseconds) before the
third phase of electrical pulses is applied to channel A. Then, the
third phase of electrical pulses is applied to channel A for
approximately 36 milliseconds to 72 milliseconds (and most
preferably for 60 milliseconds). The frequency of the individual
electrical pulses in each phase is approximately 30 Hz to 100 Hz
(and most preferably 50 Hz).
[0115] The triphasic sequential pulse train pattern described above
may be repeated approximately every 0.3 seconds (3.3 Hz) to 3
seconds (0.33 Hz). Preferably, the pulse train pattern is applied
to the patient for a total treatment time of approximately 10
minutes to 60 minutes (and most preferably 20 minutes), as desired
for a particular treatment.
[0116] Referring to FIG. 2D, electrical stimulation system 10 may
also be used to apply a plurality of cycles of a triphasic
overlapping pulse train pattern to a patient. In a typical
triphasic overlapping pulse train pattern, a first phase of
electrical pulses is applied to channel A, a second phase of
electrical pulses is applied to channel B, and a third phase of
electrical pulses is applied to channel A, wherein there is an
overlap period between the first and second phases of electrical
pulses and another overlap period between the second and third
phases of electrical pulses.
[0117] In the illustrated example, the first phase of electrical
pulses is applied to channel A for approximately 60 milliseconds to
120 milliseconds (and most preferably for 100 milliseconds). When
the first phase of electrical pulses has reached a time period of
between 40 milliseconds and 100 milliseconds (and most preferably
80 milliseconds), the second phase of electrical pulses is applied
to channel B for approximately 60 milliseconds to 120 milliseconds
(and most preferably 100 milliseconds). Thus, there is an overlap
period of approximately 0 milliseconds to 100 milliseconds (and
most preferably 20 milliseconds) during which both channel A and
channel B are providing electrical stimulation to the patient. When
the second phase of electrical pulses has reached a time period of
between 40 milliseconds and 100 milliseconds (and most preferably
80 milliseconds), the third phase of electrical pulses is applied
to channel A for approximately 36 milliseconds to 72 milliseconds
(and most preferably 60 milliseconds) (i.e., the third phase of
electrical pulses has a shorter time duration than that of the
first phase of electrical pulses). Thus, there is an overlap period
of approximately 0 milliseconds to 72 milliseconds (and most
preferably 20 milliseconds) during which both channel B and channel
A are providing electrical stimulation to the patient. The
frequency of the individual electrical pulses in each phase is
approximately 30 Hz to 100 Hz (and most preferably 50 Hz).
[0118] The triphasic overlapping pulse train pattern described
above may be repeated approximately every 0.33 seconds (3 Hz) to
3.0 seconds (0.33 Hz). Preferably, the pulse train pattern is
applied to the patient for a total treatment time of approximately
10 minutes to 60 minutes (and most preferably 20 minutes), as
desired for a particular treatment.
[0119] Functional Pulse Train Pattern
[0120] Electrical stimulation system 10 may also be used to apply a
functional pulse train pattern to a patient. The functional pulse
train pattern is applied to channel A and channel B (or to
additional channels) so as to mimic the electrical sequencing of
particular muscles involved during normal functional activity. One
skilled in the art will understand that the functional pulse train
pattern for a particular functioning activity (e.g., chewing,
moving the bolus, or swallowing) may be obtained through the use of
an electromyographic (EMG) recording device. The sequence of firing
of the muscles, firing frequencies, and the duration and frequency
of the firing of the muscles may thus be determined for
standardized healthy normal subjects and may then be programmed
into the appropriate stimulation pattern. Preferably, the
functional pulse train pattern is applied to the patient for a
total treatment time of approximately 10 minutes to 60 minutes (and
most preferably 20 minutes), as desired for a particular treatment.
Examples include, but are not limited to, gripping, holding,
pinching, sit-to-stand activities, cycling, walking, and ankle
dorsiflexion.
[0121] Low-Frequency Pulse Train Pattern
[0122] Referring to FIG. 2E, electrical stimulation system 10 may
also be used to apply a low-frequency pulse train pattern to a
patient. The low-frequency pulse train pattern may be applied to
channel A and/or channel B, wherein the individual electrical
pulses are generated on each channel at a frequency of between 4 Hz
and 200 Hz. Generally, the frequency of the electrical pulses is
selected in order to provide the desired response and release of
stimulatory or inhibitory neurotransmitters centrally and spinally
while providing the greatest comfort to the patient. If channel A
and channel B are both used, the low-frequency pulse train pattern
may be applied simultaneously to channel A and channel B, or a
different frequency may be applied on each channel to a different
area associated with various phases of swallowing. Preferably, the
low-frequency pulse train pattern is applied to the patient for a
total treatment time of approximately 5 minutes to 60 minutes (and
most preferably 20 minutes), as desired for a particular
treatment.
[0123] Frequency-Sequenced Pulse Burst Train Pattern
[0124] Referring to FIGS. 2F-2H, electrical stimulation system 10
may also be used to apply a frequency-sequenced pulse burst train
pattern to a patient. The frequency-sequenced pulse burst train
pattern may be applied to channel A and/or channel B, wherein
different sequences of modulated electrical pulses are generated at
different frequencies. Preferably, the different burst frequencies
are selected so as to selectively generate the production of
endorphin, dynorphin, and enkephalin/serotonin during each of the
respective sequences, which is believed to have beneficial effects
in the treatment of the neurological disorders of the present
invention.
[0125] In the example shown in FIG. 2F, the frequency-sequenced
pulse burst train pattern typically has a carrier frequency of 500
Hz to 100,000 Hz with a first sequence of modulated electrical
pulses generated at a burst frequency of approximately 0.1 Hz to 10
Hz (preferably 1 to 5 Hz) for a duration of approximately 1 second
to 150 seconds (preferably 10 to 120 seconds), a second sequence of
modulated electrical pulses generated at a burst frequency of
approximately 5 Hz to 20 Hz for a duration of approximately 1 to
150 seconds (preferably 10 seconds to 120 seconds), and a third
sequence of modulated electrical pulses generated at a burst
frequency of approximately 20 Hz to 250 Hz for a duration of
approximately 1 to 150 seconds (preferably 10 seconds to 120
seconds). Preferably, the frequency-sequenced pulse burst train
pattern is applied to the patient for a total treatment time of
approximately 1 minute to 60 minutes. Using this therapy, the
patient begins to receive the effects of all of the
neurotransmitters relatively quickly as the frequencies cycle
through rapidly. This therapy is also very comfortable and
moderately aggressive.
[0126] In the example shown in FIG. 2G, the frequency-sequenced
pulse burst train pattern typically has a carrier frequency of 500
Hz to 100,000 Hz with a first sequence of modulated electrical
pulses generated at a burst frequency of approximately 5 Hz to 20
Hz for a duration of approximately 1 minute to 15 minutes
(preferably 2-10 minutes), a second sequence of modulated
electrical pulses generated at a burst frequency of approximately
0.1 Hz to 10 Hz (preferably 1-5 Hz) for a duration of approximately
1 minute to 60 minutes (preferably 10 to 30 minutes), and a third
sequence of modulated electrical pulses generated at a burst
frequency of approximately 20 Hz to 250 Hz for a duration of
approximately 1 minute to 30 minutes (preferably 10 to 20 minutes).
Preferably, the frequency-sequenced pulse burst train pattern is
applied to the patient for a total treatment time of approximately
3 minutes to 50 minutes. This therapy is the most aggressive and
least tolerated but provides the longest lasting effect. The
initial effect is dynorphin (5-20 Hz), followed by endorphin (1-5
Hz), and then by enkephalin/serotonin (20-250 Hz). Since it takes
15 to 30 minutes to activate endorphin and only 5-10 minutes to
activate enkephalin/serotonin, both are present at the completion
of the treatment for maximum effect.
[0127] In the example shown in FIG. 2H, the frequency-sequenced
pulse burst train pattern has a carrier frequency of 500 Hz to
100,000 Hz with a first sequence of modulated electrical pulses
generated at a burst frequency of approximately 20 Hz to 250 Hz for
a duration of approximately 1 minute to 30 minutes (preferably 10
to 20 minutes), and a second sequence of modulated electrical
pulses generated at a burst frequency of approximately 0.1 Hz to 20
Hz (preferably 1 to 20 Hz) for a duration of approximately 1 minute
to 20 minutes (preferably 10 to 20 minutes). Preferably, the
frequency-sequenced pulse burst train pattern is applied to the
patient for a total treatment time of approximately 20 minutes to
40 minutes. This therapy is the least aggressive and best tolerated
but provides the shortest lasting effect. The initial effect is
enkephalin/serotonin (20-250 Hz) followed by endorphin (1-20 Hz).
Since it takes about 15-30 minutes to activate endorphin and only
about 5-10 minutes to activate enkephalin/serotonin, both are
present at the completion of the treatment. However, the
enkephalin/serotonin has begun to deplete as it has a relatively
short half life (15 minutes to 2 hours) compared to endorphin (2-6
hours). Stimulation at higher frequencies is better tolerated and
thus more appropriate to start with for more sensitive
patients.
[0128] It will be appreciated that when multiple channels are used
(e.g., in the case of biphasic and triphasic pulse patterns), the
first pulse pattern is preferably applied to the muscle most
seriously affected. For example, if a patient complains of muscle
weakness in chewing primarily on the right side of the body, the
motor point of the masseter muscle on the right side of the
patient's body preferably receives the pulse pattern on channel A
and the motor point of the masseter muscle on the left side of the
patient's body preferably receives the pulse pattern on channel
B.
[0129] Transcranial Stimulation Device
[0130] As shown in FIG. 1B, the transcranial stimulation device is
designated generally as reference numeral 100. The neuromuscular
electrical stimulation device 100 generally comprises an electronic
control unit 112 with one or more output connectors 114 which are
connected to one or more output cables 118 and associated electrode
pairs 118a, 118b respectively. Although one output connector 114 is
shown in FIG. 1B, it should be understood that electronic control
unit 112 may include any number of output connectors (such as one,
two, three, four, five, six, seven, eight, or more output
connectors) in accordance with the present invention. In addition,
one or more of the cables may be bifurcated into multiple (e.g., 2,
3, 4, 5, or 6) electrodes.
[0131] Output cable 118 each comprises any suitable type of
insulated conductive cable, such as a coaxial cable. In the
illustrated embodiment, output cable 118 includes a back section
122 with a connector 124 (such as a male jack) that attaches to
output connector 114, and a front section 126 that splits into a
first split end 126a and a second split end 126b. Of course, it
should be understood that each of output cable 118 could
alternatively be manufactured out of two separate leads (instead of
having a front section with split ends). In addition, output cable
118 could be connected directly to electronic control unit 112
without the use of connectors.
[0132] As can be seen in FIG. 1B, electrodes 118a, 118b are
attached to split ends 126a, 126b of output cable 118,
respectively. As such, output cable 118 and electrodes 118a, 118b
together form a first output channel. Although one channel is shown
in FIG. 1B, it should be understood that any number of channels may
be used in accordance with the present invention (provided, of
course, that the number of channels corresponds to the number of
output connectors of electronic control unit 112).
[0133] In the illustrated example, electrode 118a comprise a
positive electrode, and electrode 118b comprise a negative
electrode. As will be described in greater detail herein below, the
direct current applied to each electrodes 118a, 18b may comprise,
for example, a continuous direct current or a monophasic
(monopolar) waveform (which has absolute polarity). Thus, as used
herein, the term "positive electrode" refers to a positive
electrode and the term "negative electrode" refers to a negative
electrode (regardless of whether the electrical pulse comprises a
continuous direct current or monophasic waveform.
[0134] Electrodes 118a, 118b are each adapted to be positioned in
electrical contact with the transcranial tissue of selected regions
of a patient, as will be described in greater detail herein below
with reference to FIGS. 4A-4E. In the illustrated embodiments, each
of electrodes 118a, 118b comprises a transcutaneous electrode
having a surface electrode pad that may be placed on the skin of a
patient. As is known in the art, each of electrodes 118a, 118b may
be formed of metal or some other physiologically acceptable
conductive material and may take on a variety of different sizes
and shapes. Of course, one or more of electrodes 118a, 118b may
alternatively comprise any other type of suitable electrode in
accordance with the present invention.
[0135] Electronic control unit 112 also includes internal circuitry
(not shown) for selectively generating a series of electrical
pulses in accordance with a procedure for treating a neurological
disorder. The series of electrical pulses generated by the
circuitry are provided at output connector 114, as such, may be
applied to a patient through the channels. One skilled in the art
will understand that a variety of different circuit configurations
may be used to generate the direct current.
[0136] A variety of different transcranial direct current
electrical stimulation devices may be used and/or adapted for use
in accordance with the present invention. For example, one could
easily incorporate the protocols disclosed herein into the lomed
Phoresor II direct current stimulator. Of course, other types of
electrical stimulation devices could also be used, which are
generally available in the industry.
[0137] Referring now to FIGS. 4A-4E, at least one of electrode
118a, 118b is adapted to be positioned in electrical contact with
tissue of overlying selected regions of the patient's brain. These
regions are generally the motor cortex or, more preferably, the
somatosensory and motor cortex. In general, as shown in FIG. 4A,
there are three primary regions 135a, 135b, or 135c for
transcranial electrode placement and stimulation: the cranial
region overlying the brain somatosensory and motor control of the
facial muscles 135a; the cranial region overlying the brain
somatosensory and motor control of the upper extremity muscles
135b; and the cranial region overlying the brain somatosensory and
motor control of the lower extremity muscles 135c. It will be
appreciated that by decreasing the size of the electrode or
otherwise focusing the field, the stimulation may be primarily on
the motor cortex region (about 1 cm anterior-laterally).
[0138] Preferably, the positive electrode is applied overlying the
brain target region 135a, 135b, or 135c. The other electrode
(typically the positive electrode) is then applied in one of three
positions. First, as shown in FIG. 4B, the negative electrode is
positioned contralaterally to the same motor control area of the
brain. In such a case, the positive electrode is typically about
the same size as the negative electrode. Second, as shown in FIG.
4C, the negative electrode is placed in a "neutral" site. Preferred
neutral sites are on the forehead on the opposite prefrontal cortex
or on the patient's neck or shoulder. In these latter two
instances, the negative electrode is typically larger in size than
the positive electrode. The size differences focus the field near
the smaller electrode to provide more specificity in stimulation of
the brain somatosensory and motor control regions.
[0139] It will also be appreciated that the brain target region
135a, 135b, and 135c is opposite the affected target area in the
periphery. For example, if the patient has a stroke affecting the
right side of the brain, the left side of the body is expected to
lose function. Applying the positive electrode over the right brain
location that controls the left side of the body produces an
improvement in function of the left side of the body.
[0140] FIG. 4D illustrates two alternative embodiments for the
electrode placement for a transcranial direct current stimulator
comprising two channels, each having two electrodes 118, 118b and
120a, 120b. These embodiments are also particularly well suited for
neurological disorders which affect both sides of the patient's
body, such as those involving multiple sclerosis.
[0141] As shown in FIG. 4D (top panel), in one embodiment, the
first electrode 118a of the first channel is positioned in
electrical contact with the cranium overlying the somatosensory and
motor control region of the brain (e.g., 135a, 135b, or 135c), and
the second electrode 118b of the first channel is positioned in
electrical contact with the patient's prefrontal cortex on the
forehead on the same side of the body. The electrodes 120a, 120b of
the second channel are positioned bilaterally in a similar fashion.
This conformation is denoted as a bipolar cranial-forehead
electrode placement.
[0142] As shown in FIG. 4D (bottom panel), in another embodiment,
the first electrode 118a of the first channel is positioned in
electrical contact with cranium overlying the somatosensory and
motor control region of the brain (e.g., 135a, 135b, or 135c), and
the second electrode 118b of the first channel is positioned in
electrical contact with the patient's shoulder or neck on the same
side of the body. The electrodes 120a, 120b of the second channel
are positioned bilaterally in a similar fashion. This conformation
denoted as a bipolar cranial-neck electrode placement.
[0143] FIG. 4E illustrates two alternative embodiments for the
electrode placement for a transcranial direct current stimulator
comprising two channels, each having two electrodes 118a, 118b and
120a, 120b. These embodiments are also particularly well suited for
neurological disorders which affect both sides of the patient's
body, such as those involving multiple sclerosis or Parkinson's
disease.
[0144] In one embodiment (top panel of FIG. 4E), the first
electrode 118a of the first channel is positioned in electrical
contact with the cranium overlying the somatosensory motor control
region of the brain (e.g., 135a, 135b, or 135c), and the second
electrode 118b of the first channel is positioned in electrical
contact with the patient's prefrontal cortex on the forehead on the
opposite side of the body. The electrodes 120a, 120b of the second
channel are positioned in a similar fashion. That is, the first
electrode 120a of the second channel is positioned contralaterally
to first electrode 118a of the first channel, and the second
electrode 120b of the second channel is positioned contralaterally
to the second electrode 118b of the first channel. This
conformation is denoted as a quadripolar cranial-forehead electrode
placement. This embodiment is especially useful for transcranially
stimulating the regions of the brain associated with somatosensory
and motor control of the lower extremities, which are located in
the deeper regions of the brain.
[0145] In still another embodiment (bottom panel of FIG. 4E), the
first electrode 118a of the first channel is positioned in
electrical contact with the cranium overlying the somatosensory and
motor control region of the brain (e.g., 135a, 135b, or 135c), and
the second electrode 118b of the first channel is positioned in
electrical contact with the patient's shoulder or neck on the
opposite side of the body. The electrodes 120a, 120b of the second
channel are positioned in a similar fashion. Thus, the first
electrode 120a of the second channel is positioned contralateral to
the somatosensory and motor control region of the brain (e.g.,
135a, 135b, or 135c), and the second electrode 120b of the second
channel is positioned in electrical contact with the patient's
shoulder or neck on the opposite side of the body (i.e., but on the
same side as the target region 135a, 135b, or 135c). This
conformation is denoted as a quadripolar cranial-neck-shoulder
electrode placement. This embodiment is especially useful for
transcranially stimulating the regions of the brain associated with
somatosensory and motor control of the lower extremities, which are
located in the deeper regions of the brain.
[0146] The transcranial direct current may be continuous, pulsed,
and/or burst modulated. The current is preferably a low amperage
current, typically less than 10 mA, and more preferably about 0.5
to 2 mA, with about 1 mA being most preferred. The pulse duration
for the pulsed direct current is preferably ranges between 0.5
microsecond to 60 minutes, more preferably between about 1 and 10
microseconds, and may be uniform or non-uniform. The pulse
frequency of the pulsed direct current preferably ranges between
continuous to 1 MHz.
[0147] The direct current is applied for a period of time
sufficient to reduce the neuronal threshold for firing under the
positive electrode and/or increase the firing threshold under the
negative electrode. Although not bound by a particular theory, the
threshold of nerve activation is likely lowered near the positive
electrode because the increase in electron density makes it easier
form NMDA and other ion channels to open, and thus creates an
easier presynaptic depolarization.
[0148] FIG. 5 illustrates the timing diagram of the transcranial
direct current stimulation. In FIG. 5A, a constant direct current
is applied to the patient. The direct current is a continuous
current, and may be constant current or constant voltage or a
combination thereof. The constant DC is usually applied for a
period between 1 and 60 minutes.
[0149] In FIG. 5B, the direct current stimulation waveform
comprises a series of monopolar with a mid-frequency pattern
applied to one or more channels of electrodes/The direct current
may be constant current, constant voltage, or a combination
thereof. Typically, the carrier frequency is between 100 Hz and 1
MHz.
[0150] In FIG. 5C, the direct current stimulation waveform
comprises monopolar bursts that may be applied to one or more
output channels of electrodes. The frequency-sequenced pulse burst
train pattern has a carrier frequency of 100 Hz to 1 MHz, with a
First sequence of modulated electrical pulses generated at a burst
frequency of approximately 0.01 Hz to 250 Hz. The duration of each
burst ranges between approximately 1 seconds to 120 seconds, and
the time between each burst ranges between 1 seconds to 120 second.
The frequency may be altered randomly or set at predetermined
ranges (e.g. 0.1 to 15 Hz, or 15 to 250 Hz). Preferably, the
frequency-sequenced pulse burst train pattern is applied to the
patient for a total treatment time of approximately 1 minute to 60
minutes.
[0151] FIG. 6 demonstrates the an exemplary time linkage between
the peripheral patterned electrical stimulation and the
transcranial direct current stimulation as the latter is modulated
by a carrier signal that increases its current intensity to
coincide with the peripheral stimulation timing. The top two firing
patterns demonstrate a prototypic biphasic peripheral stimulation
timing and the third pattern demonstrates an underlying direct
current flow either continuous or phasic with an increase in
intensity beginning at about the same time as the peripheral
stimulus and ending at or shortly after the time of the peripheral
stimulation. Given the delay of nerve transmission from the upper
or lower extremity to the brain, the transcortical stimulation may
continue for an additional time period to allow for the peripheral
to brain delay. The fourth line firing pattern demonstrates a
prestimulation intensity increase that begins approximately 300
msec before the peripheral stimulation pulses in an attempt to
mimic the central neurophysiological event described as the
"berieftshaftpotential" or the preactivation of the brain just
prior to the activation of the motor neurons for intentional
movement.
[0152] Combination Therapies
[0153] The neurological disorder treatment methods of the present
invention are well-adapted to be used with other conventional
therapies, including, but not limited to, changing the diet,
swallowing exercises, changes in body posture, strengthening
exercises, coordination exercises, and even surgery. Therapeutic
agents useful for treating neurological disorders can be found in
the Merck Index and the United States Pharmacopeia, which are
periodically updated.
[0154] In particular, the electrical stimulation methods of the
present invention may also be combined with the administration of
therapeutically effective amounts of various pharmaceuticals useful
for treating neurological disorders, such as dopamine uptake
inhibitors, norepinephrine reuptake inhibitors, selective serotonin
reuptake inhibitors, monoamine oxidase inhibitors, serotonin and
noradrenaline reuptake inhibitors, norepinephrine uptake
inhibitors, dopamine agonists, acetocholinesterase inhibitors,
catechol O-methyltransferase inhibitors, and anticholinergic
agents. Antioxidants can also be used with other neuroprotective
agents as adjuncts to transcranial stimulation. The agents may be
given alone or co-administered to the patient. The agents may also
be administered along with pharmaceutically acceptable carriers and
excipients.
[0155] Suitable antioxidants of the present invention include
herbal, amino acid, mineral, vitamin, and enzymatic antioxidants.
Useful, herbal antioxidants include, but are not limited to, beta
carotene, various bioflavonoids (co-enzyme Q10, curcuma, ginkgo
biloba (preferably an extract), ginseng (preferably American,
Korean, or Siberian), Gotu Kola, grape pip (proanthocyanidins), and
quercetin). Useful amino acid antioxidants include, but are not
limited to, L-arginine, L-glutathione, L-lysine, L-methionine,
L-taurine, and L-carnitine. Useful mineral antioxidants include,
but are not limited to, boron, selenium (e.g., sodium selenite and
selenium methionine), manganese (e.g., citrate), magnesium
(preferably elemental), and zinc. Useful vitamin antioxidants
include, but are not limited to, vitamins A, B, C, E, and folic
acid (pteroylgutamic acid). The preferred B vitamins are B.sub.1
(thiamine HCl), B.sub.2, (preferably riboflavin 5'-phosphate),
B.sub.3 (niacinamide), B.sub.6 (preferably pyridoxine HCl and
activated pyridoxal 5'-phosphate), and B.sub.12 (methylcobalamin).
Other preferred vitamins are vitamin A (palminate), and vitamin E
(d-alpha tocopheryl succinate). Other preferred vitamers include
alpha-lipoic acid, lutein, lycopene (a carotenoid), succinate,
ubiquinone (co-enzyme Q10), and zeaxanthin (a yellow carotenoid).
Examples of enzymatic antioxidants include superoxide dismutase and
catalase. Other forms or equivalents of these stated compounds may
be utilized in alternative embodiments.
[0156] Suitable dopamine uptake inhibitors include, but are not
limited to, bupropion, amineptine, phenmetrazine, methylphenidate,
vanoxerine, CFT, dextropmethorphan, MDPV, and pharmaceutically
acceptable salts thereof. Most preferred are bupropion
(WIELLBUTRIN.RTM.) and methylphenidate (RITALIN.RTM.).
[0157] Suitable norepinephrine reuptake inhibitors include, but are
not limited to, tertiary amine tricyclics and secondary amine
tricyclics. Suitable examples of tertiary amine tricyclics include:
amitriptyline, clomipramine, doxepin, imipramine, and trimipramine,
and pharmaceutically acceptable salts thereof. Suitable examples of
secondary amine tricyclics include: amoxapine, desipramine,
maprotiline, nortriptyline, and protriptyline, and pharmaceutically
acceptable salts thereof. Another norepinephrine reuptake inhibitor
of use in the present invention is reboxetine.
[0158] Suitable selective serotonin reuptake inhibitors include,
but are not limited to, alaproclate, citalopram, dapoxetine,
escitalopram oxalate, fluoxetine, fluvoxamine, paroxetine,
sertraline, zimelidine, and pharmaceutically acceptable salts
thereof.
[0159] Suitable monoamine oxidase inhibitors include, but are not
limited to, harmaline, iproniazid, iproclozide, isocarboxazid,
moclobemide, nialamide, pargyline, phenelzine, tranylcypromine,
selegiline, toloxatone, tranylcypromine, rasagiline, many
tryptamines, and pharmaceutically acceptable salts thereof. Of
these, selegiline (ELDEPRYL.RTM.) is most preferred.
[0160] Suitable serotonin and noradrenaline reuptake inhibitors
include, but are not limited to, desipramine, duloxetine,
milnacipran, nefazodone, venlafaxine, and pharmaceutically
acceptable salts thereof. Of these, venlafaxine (EFFEXOR.RTM.) is
most preferred.
[0161] Suitable norepinephrine uptake inhibitors include, but are
not limited to, atomoxetine, bupropion, maprotiline, reboxetine,
and viloxazine.
[0162] Suitable dopamine agonists include, but are not limited to,
carbidopa, levodopa, bromocriptine, pergolide, dihydroergocryptine
mesylate, ropinirole, pramipexole, cabergoline, apomorphine,
piribedil, rotigotine, and lisuride hydrogen maleate. Of these,
carbidopa-levodopa (SINEMET.RTM.) is most preferred.
[0163] Suitable acetocholinesterase inhibitors include, but are not
limited to, various organophosphates (metrifonate), carbamates
(physostigmine, neostigmine, pyridostigmine, ambenonium,
demarcarium, rivastigmine), phenanthrine derivatives (galantamine),
peperidines (donepezil), tancrine, and edrophonium.
[0164] Suitable catechol O-methyltransferase inhibitors include,
but are not limited to, entacapone and tolcapone.
[0165] Suitable anticholinergic agents include trihexyphenidyl,
benzotropine, scopolamine, atropine, dicyclomine, flavoxate,
ipratropium, oxybutynin, pirenzepine, tiotropium, tolterodine,
tropicamide, solifenacin, solifenacin, darifenacin, atracurium,
doxacurium, mivacurium, pancuronium, tuborcurarine, and vecuronium.
Of these, trihexyphenidyl is most preferred.
[0166] While several exemplary embodiments of the present invention
are discussed below, those skilled in the art will readily
appreciate that various modifications may be made to these
embodiments, and the invention is not limited to the specific
electrode placements and pulse train patterns described
therein.
First Exemplary Embodiment
[0167] In a first exemplary embodiment of the present invention, as
generally illustrated in FIG. 3A, a pair of electrodes is
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more of the face
muscles. A second pair of electrodes is positioned bilaterally in a
similar manner. In addition, at least one of a pair of electrodes
is positioned in electrical contact of the area of the cranium
overlying the brain somatosensory and motor control of the face
135a as illustrated in FIG. 4A.
[0168] More specifically, as shown in FIG. 3A, a first electrode
18a is positioned in electrical contact with tissue to stimulate a
motor point of the patient's masseter muscle and/or pterygoid
muscle (medial and/or lateral). Most preferably, first electrode
18a comprises a surface electrode that is positioned on the
patient's skin about 1 body inch anterior to the lower angle of the
mandible at the prominence of the masseter muscle, along the distal
corner of the patient's mouth. A second electrode 18b is positioned
is electrical contact with tissue to stimulate the patient's
buccinators muscle and/or orbicularis oris muscle. Most preferably,
second electrode 18b comprises a surface electrode that is
positioned on the patient's skin at the distal corner of the mouth.
Another pair of electrodes 20a, 20b is provided bilaterally in a
similar position as generally illustrated in FIG. 3A.
[0169] In this exemplary embodiment, the pulse train pattern
applied to the facial muscles comprises a biphasic overlapping
pulse train pattern having the following parameters:
Pulse duration of individual electrical pulses: 50-70 microseconds
Current amplitude of individual electrical pulses: 25-70 milliamps
Duration of first phase: 100 milliseconds Duration of overlap: 20
milliseconds Duration of second phase: 100 milliseconds Frequency
of pulse train pattern: 1.6 hertz Total treatment time: 20 minutes
Total number of treatments: 18 (over six weeks) Frequency of
individual electrical pulses (in each phase): 50 hertz
[0170] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.015 mA/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the facial muscles 135a.
Second Exemplary Embodiment
[0171] In a second exemplary embodiment of the present invention,
as generally illustrated in FIG. 3B, a pair of electrodes is
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more portions of the
tongue to improve motor control of the tongue and to the muscles
associated with chewing and/or swallowing. A second pair of
electrodes is positioned bilaterally in a similar manner. In
addition, at least one of a pair of electrodes is positioned in
electrical contact of the area of the cranium overlying the brain
somatosensory and motor control of the face 135a as illustrated in
FIG. 4A.
[0172] More specifically, as shown in FIG. 3B, a first electrode
18a is positioned in electrical contact with tissue to stimulate a
motor point of the patient's tongue. Most preferably, first
electrode 18a comprises a surface electrode that is positioned on
the patient's skin tongue or pharynx. A second electrode 18b is
positioned is electrical contact with tissue to stimulate the
patient's masseter and/or facial muscles. Most preferably, second
electrode 18b comprises a surface electrode that is positioned in
electrical contact with tissue to simulate a motor point of the
patient's masseter muscle and/or buccinators muscle and/or
orbicularis oris muscle. Most preferably, second electrode 18b
comprises a surface electrode that is positioned on the patient's
skin along the jaw about one inch anterior to the lower angle of
the mandible at the prominence of the masseter muscle or over the
motor point of the patient's buccinator muscle and/or orbicularis
oris muscle. Another pair of electrodes 20a, 20b is provided
bilaterally in a similar position as generally illustrated in FIG.
3B.
[0173] In this exemplary embodiment, the pulse train pattern
comprises a biphasic overlapping pulse train pattern having the
following parameters:
Pulse duration of individual electrical pulses: 50-70 microseconds
Current amplitude of individual electrical pulses: 25-70 milliamps
Duration of first phase: 100 milliseconds Duration of overlap: 20
milliseconds Duration of second phase: 100 milliseconds Frequency
of pulse train pattern: 1.6 hertz Total treatment time: 20 minutes
Total number of treatments: 18 (over six weeks) Frequency of
individual electrical pulses (in each phase): 50 hertz
[0174] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.015 mA/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the facial muscles 135a.
Third Exemplary Embodiment
[0175] In a second exemplary embodiment of the present invention,
as generally illustrated in FIG. 3C, a pair of electrodes is
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more of the face
muscles used to create proper lip seal and to the muscles
associated with the posterior neck region. A second pair of
electrodes is positioned bilaterally in a similar manner. In
addition, at least one of a pair of electrodes is positioned in
electrical contact of the area of the cranium overlying the brain
somatosensory and motor control of the face 135a as illustrated in
FIG. 4A.
[0176] More specifically, as shown in FIG. 3C, a first electrode
18a is positioned in electrical contact with tissue to stimulate a
motor point of the patient's buccinator and/or orbicularis oris
muscles as demonstrated in FIG. 3C (lower panel), or masseter
and/or pterygoid muscles (upper panel). Most preferably, first
electrode 18a comprises a surface electrode that is positioned on
the patient's skin or over the motor point of the patient's
buccinator muscle and/or orbicularis oris muscle. Most preferably,
first electrode 18a comprises a surface electrode that is
positioned on the patient's skin along the distal corner of the
patient's mouth in (upper panel) or along the jaw about one inch
anterior to the lower angle of the mandible at the prominence of
the masseter muscle (lower panel). A second electrode 18b is
positioned in electrical contact with tissue to stimulate the
patient's cervical paraspinal muscles. Most preferably, second
electrode 18b comprises a surface electrode that is positioned on
the patient's skin in the posterior neck region just lateral to the
one or more of the cervical vertebrae, most preferably near the C1,
C2, C3, and/or C4 cervical vertebrae. Another pair of electrodes
20a, 20b is provided bilaterally in a similar position as generally
illustrated in FIG. 3B.
[0177] In this exemplary embodiment, the pulse train pattern
comprises a biphasic overlapping pulse train pattern having the
following parameters:
Pulse duration of individual electrical pulses: 50-70 microseconds
Current amplitude of individual electrical pulses: 25-70 milliamps
Duration of first phase: 100 milliseconds Duration of overlap: 20
milliseconds Duration of second phase: 100 milliseconds Frequency
of pulse train pattern: 1.6 hertz Total treatment time: 20 minutes
Total number of treatments: 18 (over six weeks) Frequency of
individual electrical pulses (in each phase): 50 hertz
[0178] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.015 mA/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the facial muscles 135a.
Fourth Exemplary Embodiment
[0179] In a fourth exemplary embodiment of the present invention,
as generally illustrated in FIG. 3D, a pair of electrodes is
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more of the muscles
associated with swallowing in the posterior neck region and the
muscles involved in maintaining proper posture during swallowing. A
second pair of electrodes is positioned bilaterally in a similar
manner. In addition, at least one of a pair of electrodes is
positioned in electrical contact of the area of the cranium
overlying the brain somatosensory and motor control of the face and
neck 135 a as illustrated in FIG. 4A
[0180] More specifically, as shown in FIG. 3D, a first electrode
18a is positioned in electrical contact with tissue to stimulate a
motor point of the patient's upper trapezius muscle. Most
preferably, first electrode 18a comprises a surface electrode that
is positioned on the patient's skin along at the midpoint of the
upper trapezius. A second electrode 18b is positioned is electrical
contact with tissue to stimulate the patient's cervical paraspinal
muscles. Most preferably, second electrode 18b comprises a surface
electrode that is positioned on the patient's skin in the posterior
neck region just lateral to the one or more of the cervical
vertebrae, most preferably near the C1, C2, C3, and/or C4 cervical
vertebrae. Another pair of electrodes 20a, 20b is provided
bilaterally in a similar position as generally illustrated in FIG.
3D.
[0181] In this exemplary embodiment, the pulse train pattern
comprises a biphasic overlapping pulse train pattern having the
following parameters:
Pulse duration of individual electrical pulses: 50-70 microseconds
Current amplitude of individual electrical pulses: 20-70 milliamps
Duration of first phase: 100 milliseconds Duration of overlap: 20
milliseconds Duration of second phase: 100 milliseconds Frequency
of pulse train pattern: 1.6 hertz Total treatment time: 20 minutes
Total number of treatments: 18 (over six weeks) Frequency of
individual electrical pulses (in each phase): 50 hertz
[0182] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.015 mA/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the facial muscles 135a.
Fifth Exemplary Embodiment
[0183] In a fifth exemplary embodiment of the present invention, as
generally illustrated in FIG. 3E, two pair of electrodes is
positioned in electrical contact with the patient's neck. In
addition, at least one of a pair of electrodes is positioned in
electrical contact of the area of the cranium overlying the brain
somatosensory and motor control of the face and neck 135a as
illustrated in FIG. 4A. This embodiment is particularly useful for
improving posture in patients suffering from a neurological
disorder.
[0184] More specifically, as shown in FIG. 3E, a first electrode
18a is positioned in electrical contact with tissue to stimulate
the patient's lower cervical and upper thoracic paraspinal muscles.
Most preferably, first electrode 18a comprises a surface electrode
that is positioned on the patient's skin along at the midpoint of
the upper trapezius just lateral to the spinal cord, most
preferably near the C6, C7, T1, T2, T3, and/or T4 cervical and
thoracic vertebrae. A second electrode 18b is positioned is
electrical contact with tissue to stimulate the patient's cervical
paraspinal muscles. Most preferably, second electrode 18b comprises
a surface electrode that is positioned on the patient's skin in the
posterior neck region just lateral to the one or more of the
cervical vertebrae, most preferably near the C1, C2, C3, and/or C4
cervical vertebrae. Another pair of electrodes 20a, 20b is provided
bilaterally in a similar position as generally illustrated in FIG.
3E.
[0185] In this exemplary embodiment, the pulse train pattern
comprises a biphasic overlapping pulse train pattern having the
following parameters:
Pulse duration of individual electrical pulses: 50-70 microseconds
Current amplitude of individual electrical pulses: 20-70 milliamps
Duration of first phase: 100 milliseconds Duration of overlap: 20
milliseconds Duration of second phase: 100 milliseconds Frequency
of pulse train pattern: 1.6 hertz Total treatment time: 20 minutes
Total number of treatments: 18 (over six weeks) Frequency of
individual electrical pulses (in each phase): 50 hertz
[0186] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.015 mA/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the neck muscles 135a.
Sixth Exemplary Embodiment
[0187] In a sixth exemplary embodiment of the present invention, as
generally illustrated in FIG. 3F, two pair of electrodes is
positioned in electrical contact with the patient's mid-back or
upper back. In addition, at least one of a pair of electrodes is
positioned in electrical contact of the area of the cranium
overlying the brain somatosensory and motor control of the mid-back
and upper back 135b as illustrated in FIG. 4A. This embodiment is
particularly useful for improving posture in patients suffering
from a neurological disorder.
[0188] More specifically, as shown in FIG. 3F, the electrodes are
positioned in electrical contact with the erector spinae and
trapezius muscles. The first electrode 18a is in electrical contact
with tissue to stimulate the patient's thoracic paraspinal muscles.
Most preferably, second electrode 18a comprises a surface electrode
that is positioned on the patient's skin in just lateral to the one
or more of the thoracic vertebrae, most preferably near the T3, T4,
T5, 16, T7, T8, and/or T9 thoracic vertebrae. A second electrode
18b is positioned in electrical contact with tissue to stimulate
the patient's upper thoracic paraspinal muscles. Most preferably,
first electrode 18a comprises a surface electrode that is
positioned on the patient's skin along at the midpoint of the upper
trapezius just lateral to the spinal cord, most preferably near the
C7, T1, T2, T3, and/or T4 cervical and thoracic vertebrae. Another
pair of electrodes 20a, 20b is provided bilaterally in a similar
position as generally illustrated in FIG. 3F.
[0189] In this exemplary embodiment, the pulse train pattern
comprises a biphasic overlapping pulse train pattern having the
following parameters:
Pulse duration of individual electrical pulses: 50-70 microseconds
Current amplitude of individual electrical pulses: 20-70 milliamps
Duration of first phase: 100 milliseconds Duration of overlap: 20
milliseconds Duration of second phase: 100 milliseconds Frequency
of pulse train pattern: 1.6 hertz Total treatment time: 20 minutes
Total number of treatments: 36 Frequency of individual electrical
pulses (in each phase): 50 hertz
[0190] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.015 mA/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the mid-back and upper back muscles 135b.
Seventh Exemplary Embodiment
[0191] In a seventh exemplary embodiment of the present invention,
as generally illustrated in FIG. 3G, a pair of electrodes is
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more of the muscles
associated with lumbar stabilization. A second pair of electrodes
is positioned bilaterally in a similar manner. In addition, at
least one of a pair of electrodes is positioned in electrical
contact of the area of the cranium overlying the brain
somatosensory and motor control of the trunk 135c as illustrated in
FIG. 4A.
[0192] More specifically, as shown in FIG. 3G, a first electrode
18a is positioned in electrical contact with the tissue of the
patient's lumbar region. Most preferably, first electrode 18a
comprises a surface electrode that is positioned posteriorly on the
patient's skin in the lower back region over the lower paraspinal
muscles just lateral to one or more of the lower thoracic and/or
lumbar vertebrae, most preferably near the L1, L2, L3, L4, and/or
L5 lumbar vertebrae. A second electrode 18b is positioned is
electrical contact with tissue to stimulate the patient's abdominal
muscles. Most preferably, second electrode 18b comprises a surface
electrode that is positioned anteriorly on the patient's skin at
about the level of the umbilicus, about half-way between the
anterior superior iliac spine ("ASIS") and the anterior midline
over the combined abdominal muscle. Another pair of electrodes 20a.
20b is provided bilaterally in a similar position as generally
illustrated in FIG. 3G.
[0193] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
Pulse duration of individual electrical pulses: 50-70 microseconds
Current amplitude of individual electrical pulses: 20-90 milliamps
Duration of first phase: 200 milliseconds Duration of overlap: 40
milliseconds Duration of second phase: 200 milliseconds Duration of
overlap: 40 milliseconds Duration of third phase: 120 milliseconds
Frequency of pulse train pattern: 0.67 hertz Frequency of
individual electrical pulses (in each phase): 50 hertz Total
treatment time: 20 minutes Total number of treatments: 18 (over six
weeks)
[0194] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.015 mA/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the lumbar and abdominal muscles 135c.
Eighth Exemplary Embodiment
[0195] In an eighth exemplary embodiment of the present invention,
as generally illustrated in FIG. 3H, four pairs of electrodes are
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more of the muscles
involved in trunk flexion and extension. Two channels may be used
with a bifurcating cable as illustrated in FIG. 3H.
[0196] More specifically, as shown in FIG. 3H, a first electrode
18a is positioned in electrical contact with the tissue of the
patient's upper lumbar and upper abdominal region. Most preferably,
first electrode 18a comprises a surface electrode that is
positioned posteriorly on the patient's skin in the lower back
region over the multifidus muscle, just lateral to one or more of
the lower thoracic and/or lumbar vertebrae, most preferably near
the L1, L2, L3, L4, and/or L5 lumbar vertebrae. The second
electrode 18b of the first channel is also placed posteriorly on
the patient's skin in the lower back region over the multifidus
muscle, just lateral to one or more of the lower thoracic and/or
lumbar vertebrae, most preferably near the T9, T10, T11, T12, L1,
L2, and/or L3 lumbar vertebrae. A third electrode 18c and fourth
electrode 18d are placed over the same side abdominal muscles at
the same vertebral level to stimulate the patient's lower abdominal
muscles. Another set of four electrodes 20a, 20b, 20c, and 20d are
provided bilaterally in a similar position as generally illustrated
in FIG. 3H.
[0197] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
Pulse duration of individual electrical pulses: 50-70 microseconds
Current amplitude of individual electrical pulses: 20-70 milliamps
Duration of first phase: 200 milliseconds Duration of overlap: 40
milliseconds Duration of second phase: 200 milliseconds Duration of
overlap: 40 milliseconds Duration of third phase: 120 milliseconds
Frequency of pulse train pattern: 0.67 hertz Frequency of
individual electrical pulses (in each phase): 50 hertz Total
treatment time: 20 minutes Total number of treatments: 18 (over six
weeks)
[0198] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.015 ma/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the lumbar and abdominal muscles 135c.
Ninth Exemplary Embodiment
[0199] In a ninth exemplary embodiment of the present invention, as
generally illustrated in FIG. 3I, a pair of electrodes is
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more of the muscles
involved in the elbow flexion. A second pair of electrodes is
positioned in electrical contact with the patient's tissue in order
to provide stimulation to one or more of the muscles involved in
elbow extension. In addition, at least one of a pair of electrodes
is positioned in electrical contact of the area of the cranium
overlying the brain somatosensory and motor control of the upper
extremity 135b as illustrated in FIG. 4A.
[0200] More specifically, as shown in FIG. 3I, first and second
electrodes 18a, 18b are positioned in electrical contact with
tissue to stimulate the biceps brachii muscle of the patient. Most
preferably, first electrode 18a comprises a surface electrode that
is positioned on the patient's skin anteriorly on the upper arm
above the biceps brachii muscle insertion. Most preferably, the
second electrode 18b comprises a surface electrode that is
positioned anteriorly on the patient's skin on the upper arm just
below the biceps brachii muscle origin. Another pair of electrodes
20a, 20b is provided in electrical contact with tissue to stimulate
the triceps brachii muscle of the patient. Most preferably, first
electrode 20a comprises a surface electrode that is positioned
posteriorly on the patient's skin on the upper arm above the
triceps brachii muscle insertion. Most preferably, the second
electrode 20b comprises a surface electrode that is positioned on
the patient's skin on the upper arm just above the triceps brachii
muscle origin.
[0201] During treatment, the first and second channels are
positioned on the right or left arm, and a patterned pulse train is
applied as discussed more fully below. It will be appreciated that
the muscles involved in elbow flexion and extension may be
bilaterally stimulated when the electrical stimulation device
contains at least four channels. Alternatively, two electrical
stimulation devices can be used for bilateral stimulation: one to
simulate the right arm, and one to stimulate the left arm such as
for stimulation of the bilateral biceps or triceps in a
reciprocating functional pattern similar to FIG. 3N.
[0202] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
Pulse duration of individual electrical pulses: 50-70 microseconds.
Current amplitude of individual electrical pulses: 30-70 milliamps
Duration of first phase: 100 milliseconds Duration of overlap: 20
milliseconds Duration of second phase: 100 milliseconds Duration of
overlap: 20 milliseconds Duration of third phase: 60 milliseconds
Frequency of pulse train pattern: 0.67 seconds Total treatment
time: 20 minutes Total number of treatments: 18 (over six weeks)
Frequency of individual electrical pulses (in each phase): 50
hertz
[0203] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.015 ma/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the upper extremities 135b.
Tenth Exemplary Embodiment
[0204] In a tenth exemplary embodiment of the present invention, as
generally illustrated in FIG. 3J, two pairs of electrodes are
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more of the muscles
involved in the internal and external rotation of the shoulder. In
addition, at least one of a pair of electrodes is positioned in
electrical contact of the area of the cranium overlying the brain
somatosensory and motor control of the upper extremity 135b as
illustrated in FIG. 4A.
[0205] More specifically, as shown in FIG. 3J, first pair of
electrodes 18a, 18b are provided to provide simulation to muscles
involved in the internal rotation of the shoulder. A first
electrode 18a is positioned in electrical contact with tissue to
stimulate the biceps brachii muscle. Most preferably, first
electrode 18a comprises a surface electrode that is positioned on
the patient's skin near the midpoint of the biceps brachii muscle.
A second electrode 18b is positioned is electrical contact with
tissue to stimulate the patient's pectoralis major and anterior
deltoid muscle. Most preferably, second electrode 18b comprises a
surface electrode that is positioned anteriorly on the patient's
skin just above the axilla.
[0206] Another pair of electrodes 20a, 20b is provided to stimulate
the muscles involved in the external rotation of the shoulder. A
first electrode 20a is positioned in electrical contact with tissue
to stimulate the triceps brachi muscle. Most preferably, first
electrode 20a comprises a surface electrode that is positioned in
near the midpoint of the triceps brachii. A second electrode 20b is
positioned is electrical contact with tissue to stimulate the
infraspinatus teres minor and the posterior deltoid muscle. Most
preferably, second electrode 20b comprises a surface electrode that
is positioned posteriorly on the patient's skin just above the
underarm.
[0207] During treatment, the first and second channels are
positioned on the right or left arm, and a patterned pulse train is
applied as discussed more fully below. It will be appreciated that
the muscles involved in shoulder rotation may be bilaterally
stimulated when the electrical stimulation device contains at least
four channels. Alternatively, two electrical stimulation devices
can be used for bilateral stimulation: one to simulate the right
shoulder, and one to stimulate the left shoulder.
[0208] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
Pulse duration of individual electrical pulses: 50-70 microseconds
Current amplitude of individual electrical pulses: 30-70 milliamps
Duration of first phase: 100 milliseconds Duration of overlap: 20
milliseconds Duration of second phase: 100 milliseconds Duration of
overlap: 20 milliseconds Duration of third phase: 60 milliseconds
Frequency of pulse train pattern: 0.67 hertz Total treatment time:
20 minutes Total number of treatments: 18 (over six weeks)
Frequency of individual electrical pulses (in each phase): 50
hertz
[0209] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.015 ma/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the upper extremities 135b.
Eleventh Exemplary Embodiment
[0210] In an eleventh exemplary embodiment of the present
invention, as generally illustrated in FIG. 3J, two pairs of
electrodes are positioned in electrical contact with the patient's
tissue in order to provide electrical stimulation to one or more of
the muscles involved in the flexion and extension of the shoulder
and elbow. In addition, at least one of a pair of electrodes is
positioned in electrical contact of the area of the cranium
overlying the brain somatosensory and motor control of the upper
extremity 135b as illustrated in FIG. 4A
[0211] More specifically, as shown in FIG. 3J, first pair of
electrodes 18a, 18b are provided to provide simulation to muscles
involved in the flexion of the shoulder and elbow. A first
electrode 18a is positioned in electrical contact with tissue to
stimulate the biceps brachii muscle. Most preferably, first
electrode 18a comprises a surface electrode that is positioned on
the patient's skin near the midpoint of the biceps brachii muscle.
A second electrode 18b is positioned is electrical contact with
tissue to stimulate the patient's anterior deltoid muscle. Most
preferably, second electrode 18b comprises a surface electrode that
is positioned anteriorly on the patient's skin just above the
axilla.
[0212] Another pair of electrodes 20a, 20b is provided to stimulate
the muscles involved in the extension of the shoulder. A first
electrode 20a is positioned in electrical contact with tissue to
stimulate the triceps brachi muscle. Most preferably, first
electrode 20a comprises a surface electrode that is positioned in
near the distal end of the triceps brachii. A second electrode 20b
is positioned is electrical contact with tissue to stimulate the
posterior deltoid muscle. Most preferably, second electrode 20b
comprises a surface electrode that is positioned posteriorly on the
patient's skin just above the axilla.
[0213] During treatment, the first and second channels are
positioned on the right or left arm, and a patterned pulse train is
applied as discussed more fully below. It will be appreciated that
the muscles involved in shoulder rotation may be bilaterally
stimulated when the electrical stimulation device contains at least
four channels. Alternatively, two electrical stimulation devices
can be used for bilateral stimulation: one to simulate the right
shoulder, and one to stimulate the left shoulder.
[0214] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
Pulse duration of individual electrical pulses: 50-70 microseconds
Current amplitude of individual electrical pulses: 30-70 milliamps
Duration of first phase: 100 milliseconds Duration of overlap: 20
milliseconds Duration of second phase: 100 milliseconds Duration of
overlap: 20 milliseconds Duration of third phase: 60 milliseconds
Frequency of pulse train pattern: 0.67 hertz Total treatment time:
20 minutes Total number of treatments: 18 (over six weeks)
Frequency of individual electrical pulses (in each phase): 50
hertz
[0215] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.015 ma/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the upper extremities 135b.
Twelfth Exemplary Embodiment
[0216] In an twelfth exemplary embodiment of the present invention,
also generally illustrated in FIG. 3L, a pair of electrodes is
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more of the muscles
associated with wrist flexion, extension, pronation and supination
and extension and/or finger flexion and extension as a treatment
for neurological disorders in the upper extremities. The treated
muscles include the flexor digitorum superficialis, flexor carpi
radialis, flexor carpi ulnaris, extensor digitorum, extensor digiti
minimi muscle, extensor carpi ulnaris, extensor carpi radialis
longus, and/or extensor carpi radialis brevis. In addition, at
least one of a pair of electrodes is positioned in electrical
contact of the area of the cranium overlying the brain
somatosensory and motor control of the upper extremity 135b as
illustrated in FIG. 4A.
[0217] More specifically, as generally shown in FIG. 3L, a
two-channel system is used to apply electrical stimulation to
muscles of the wrist and fingers. In the first channel, a first
electrode 18a is positioned in electrical contact with tissue of
the proximal palmar surface to stimulate the hand intrinsic
muscles. Most preferably, first electrode 18a comprises a surface
electrode that is positioned on the patient's skin across the
thenar and the hypothenar eminence on the palmar/anterior side of
the forearm at the base of the wrist just below the wrist crease. A
second electrode is positioned in electrical contact with tissue to
stimulate the muscles of the volar surface of the proximal forearm.
Most preferably, second electrode 18b comprises a surface electrode
that is positioned on the patient's skin on the palmar/anterior
side of lower arm just below the elbow joint.
[0218] For the second channel, the first electrode 20a is
positioned in electrical contact with a tissue to stimulate a motor
point of the patient's extensor digitorum and pollicis muscles.
Most preferably, first electrode 20a comprises a surface electrode
that is positioned on the patient's skin on the dorsal/posterior
side of the lower arm about 1/3 of the way between the wrist crease
and elbow joint. The second electrode 20b is positioned in
electrical contact with tissue to stimulate a motor point of the
patient's proximal extensor muscles of the forearm. Most
preferably, second electrode 20b comprises a surface electrode that
is positioned on the patient's skin on the dorsal/posterior side of
the lower arm just below the elbow joint.
[0219] During treatment, the first and second channels are
positioned on the right or left arm, and a patterned pulse train is
applied to the arm and wrist as discussed more fully below. It will
be appreciated that the muscles involved in wrist extension and
flexion may be bilaterally stimulated when the electrical
stimulation device contains at least four channels. Alternatively,
two electrical stimulation devices can be used for bilateral
stimulation: one to simulate the right wrist and lingers, and one
to stimulate the left wrist and fingers.
[0220] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
Pulse duration of individual electrical pulses: 50-70 microseconds
Current amplitude of individual electrical pulses: 30-70 milliamps
Duration of first phase: 100 milliseconds Duration of overlap: 20
milliseconds Duration of second phase: 100 milliseconds Duration of
overlap: 20 milliseconds Duration of third phase: 60 milliseconds
Frequency of pulse train pattern: 0.67 hertz Total treatment time:
20 minutes Total number of treatments: 18 (over six weeks)
Frequency of individual electrical pulses (in each phase): 50
hertz
[0221] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.015 ma/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the upper extremities 135b.
Thirteenth Exemplary Embodiment
[0222] In a thirteenth exemplary embodiment of the present
invention, as generally illustrated in FIG. 3M, two pairs pair of
electrodes are positioned in electrical contact with the patient's
tissue in order to provide electrical stimulation to one or more of
the muscles involved in movements of the upper extremities.
[0223] More specifically, as shown in FIG. 3M, first pair of
electrodes 18a, 18b are provided to provide simulation to the
anterior portion of the arm. A first electrode 18a is positioned in
electrical contact with tissue of the proximal palmar surface to
stimulate the hand intrinsic muscles. Most preferably, first
electrode 18a comprises a surface electrode that is positioned on
the patient's skin across the thenar and the hypothenar eminence on
the palmar/anterior side of the forearm at the base of the wrist
just below the wrist crease. A second electrode 18b is positioned
is electrical contact with tissue to stimulate the patient's biceps
brachii muscles and median and ulnar nerves. Most preferably,
second electrode 18b comprises a surface electrode that is
positioned anterior and medially (to capture the median and ulnar
nerve bundle) on the patient's skin near the midpoint of the biceps
brachii muscle.
[0224] Another pair of electrodes 20a, 20b is provided to stimulate
the posterior muscles of the arm. The first electrode 20a is
positioned in electrical contact with tissue to stimulate a motor
point of the patient's proximal extensor muscles of the forearm.
Most preferably, first electrode 20a comprises a surface electrode
that is positioned on the patient's skin on the dorsal/posterior
side of the lower arm just below the elbow joint A second electrode
20b is positioned is electrical contact with tissue to stimulate
the patient's triceps brachii muscles. Most preferably, second
electrode 20b comprises a surface electrode that is positioned
posteriorly on the patient's skin near the midpoint of the triceps
brachii muscle.
[0225] During treatment, the first and second channels are
positioned on the right or left arm, and a patterned pulse train is
applied to the arm and wrist as discussed more fully below. It will
be appreciated that the muscles involved in arm movement may be
bilaterally stimulated when the electrical stimulation device
contains at least four channels. Alternatively, two electrical
stimulation devices can be used for bilateral stimulation: one to
simulate the right wrist and fingers, and one to stimulate the left
wrist and fingers.
[0226] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
Pulse duration of individual electrical pulses: 50-70 microseconds
Current amplitude of individual electrical pulses: 30-70 milliamps
Duration of first phase: 100 milliseconds Duration of overlap: 20
milliseconds Duration of second phase: 100 milliseconds Duration of
overlap: 20 milliseconds Duration of third phase: 60 milliseconds
Frequency of pulse train pattern: 0.67 hertz Total treatment time:
20 minutes Total number of treatments: 18 (over six weeks)
Frequency of individual electrical pulses (in each phase): 50
hertz
[0227] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.015 ma/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex-region
controlling the upper extremities 135b.
Fourteenth Exemplary Embodiment
[0228] In a fourteenth exemplary embodiment of the present
invention, as generally illustrated in FIG. 3N, two pairs of
electrodes are positioned in electrical contact with the patient's
tissue in order to provide electrical stimulation to the patient's
triceps brachii muscles. In addition, at least one of a pair of
electrodes is positioned in electrical contact of the area of the
cranium overlying the brain somatosensory and motor control of the
upper extremity 135b as illustrated in FIG. 4A. An alternative
placement is illustrated in FIG. 4D using a two channel stimulator
placed bilaterally over the brain somatosensory and motor control
of the upper extremity 135b. The patient is preferably instructed
to participate in alternating reciprocal movements during
treatment, such as those involved in cycling.
[0229] More specifically, as shown in FIG. 3N, first and second
electrodes 18a, 18b are positioned in electrical contact with
tissue to stimulate the triceps brachii muscle of the patient.
Another pair of electrodes 20a, 20b is provided in electrical
contact with tissue to stimulate the other triceps brachii muscle
of the patient.
[0230] In this exemplary embodiment, the pulse train pattern
comprises a functional pulse train pattern having the following
parameters:
Pulse duration of individual electrical pulses: 50-70 microseconds
Current amplitude of individual electrical pulses: 30-70 milliamps
Duration of first phase: 200 milliseconds Duration of delay: 300
milliseconds Duration of second phase: 200 milliseconds Duration of
delay: 300 milliseconds Frequency of pulse train pattern: 1.0 hertz
Total treatment time: 10-20 minutes Total number of treatments: 18
(over six weeks) Frequency of individual electrical pulses (in each
phase): 50 hertz
[0231] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.015 ma/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the upper extremities 135b either unilaterally as in
FIG. 4A or bilaterally as in FIG. 4D. The timing parameters to be
adjusted for the desired speed or cycles per minute. The current
embodiment demonstrates timing pattern for upper extremity cycling
at 1 Hz.
Fifteenth Exemplary Embodiment
[0232] In a fifteenth exemplary embodiment of the present
invention, as shown in FIG. 3O, two pairs of electrodes are
positioned in electrical contact with the patient's tissue in order
to provide electrical stimulation to one or more of the muscles
involved in movements of the scapula, specifically scapular
abduction and upward rotation.
[0233] More specifically, as shown in FIG. 3O, first pair of
electrodes 18a, 18b are applied to provide simulation to the upper
and mid trapezius and rhomboids. Most preferably, first electrode
18a comprises a surface electrode that is positioned on the
patient's skin across the midpoint of the upper trapezius, and the
second electrode 18b comprises a surface electrode that is
positioned on the patient's skin to stimulate the trapezius and
lower cervical and upper thoracic paraspinal muscles near the C6,
C7, T1, T2, T3, and/or T4 cervical and thoracic vertebrae
[0234] The second pair of electrodes 20a, 20b are applied to
provide stimulation to the lower trapezius and serratus anterior
muscles and nerves. The first electrode 20a of the second channel
is positioned in electrical contact with tissue to simulate the
serratus anterior muscle, and the second electrode 20b is
positioned in electrical contact with tissue to simulate the lower
trapezius muscle and the thoracic paraspinal muscles near the T3,
T4, T5, T6, T7, T8, and/or T9 thoracic vertebrae of said
patient,
[0235] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
Pulse duration of individual electrical pulses: 50-70 microseconds
Current amplitude of individual electrical pulses: 30-70 milliamps
Duration of first phase: 100 milliseconds Duration of overlap: 20
milliseconds Duration of second phase: 100 milliseconds Duration of
overlap: 20 milliseconds Duration of third phase: 60 milliseconds
Frequency of pulse train pattern: 0.67 hertz Total treatment time:
20 minutes Total number of treatments: 18 (over six weeks)
Frequency of individual electrical pulses (in each phase): 50
hertz
[0236] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.015 ma/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the upper extremities 135b.
Sixteenth Exemplary Embodiment
[0237] In a sixteenth exemplary embodiment of the present
invention, as generally illustrated in FIG. 3P, two pairs pair of
electrodes are positioned in electrical contact with the patient's
tissue in order to provide electrical stimulation to one or more of
the muscles involved in movements of the upper extremities.
[0238] More specifically, as shown in FIG. 3P, first pair of
electrodes 18a, 18b are provided to provide simulation to the
posterior portion of the arm. A first electrode 18a is positioned
in electrical contact with tissue of the posterior lateral neck
surface. Most preferably, first electrode 18a comprises a surface
electrode that is positioned on the patient's skin posterior
lateral neck surface in the region of C6, C7, and T1. A second
electrode 18b is positioned is electrical contact with tissue to
stimulate the patient's posterior deltoid muscle. Most preferably,
second electrode 18b comprises a surface electrode that is
positioned on the dorsal surface of the deltoid muscle, posterior
and inferior to the acromion.
[0239] Another pair of electrodes 20a, 20b is provided to stimulate
the posterior muscles of the arm. The first electrode 20a is
positioned in electrical contact with tissue to stimulate a motor
point of the patient's proximal extensor muscles of the forearm.
Most preferably, first electrode 20a comprises a surface electrode
that is positioned on the patient's skin on the dorsal/posterior
side of the lower arm, over the extensor carpi radialis longus
origin. A second electrode 20b is positioned is electrical contact
with tissue to stimulate the patient's first dorsal interosseus
muscle. Most preferably, second electrode 20b comprises a surface
electrode that is positioned posteriorly on the patient's skin in
the web-space between the thumb and first metacarpal bone.
[0240] During treatment, the first and second channels are
positioned on the right or left arm, and a patterned pulse train is
applied to the arm as discussed more fully below. It will be
appreciated that the muscles involved in arm movement may be
bilaterally stimulated when the electrical stimulation device
contains at least four channels. Alternatively, two electrical
stimulation devices can be used for bilateral stimulation: one to
simulate the right upper extremity, and one to stimulate the left
upper extremity.
[0241] In this exemplary embodiment, the pulse train pattern
comprises a low frequency pulse train pattern or a
frequency-sequenced pulse burst train pattern having the following
parameters:
Low Frequency Pulse Train Pattern:
[0242] Pulse duration of individual electrical pulses: 200
microseconds Current amplitude of individual electrical pulses:
10-50 milliamps Total treatment time: 20 minutes Total number of
treatments: 1.8 (over six weeks) Frequency of individual electrical
pulses (in each phase): 50 hertz
Frequency Sequenced Pulse Burst Train Pattern
Carrier Frequency: 500 Hz-100,000 Hz
[0243] First Sequence Burst Frequency: 2-20 Hz for up to 10 minutes
Second Sequence Burst Frequency: 0.1 Hz-5 Hz for up to thirty
minutes Third Sequence Burst Frequency: 20 Hz-250 Hz for up to 20
minutes Current amplitude of individual electrical pulses: 10-50
milliamps Total treatment time: up to 60 minutes Total number of
treatments: 18 (over six weeks)
[0244] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.015 mA/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the upper extremities 135b.
Seventeenth Exemplary Embodiment
[0245] In a seventeenth exemplary embodiment of the present
invention, as generally illustrated in FIG. 3Q, two pairs pair of
electrodes are positioned in electrical contact with the patient's
tissue in order to provide electrical stimulation to one or more of
the muscles involved in movements of the lower extremities.
[0246] More specifically, as shown in FIG. 3Q, first pair of
electrodes 18a, 18b are provided to provide simulation to the
anterior portion of the lower extremity. A first electrode 18a is
positioned in electrical contact with tissue of the thigh above the
patella. Most preferably, first electrode 18a comprises a surface
electrode that is positioned on the patient's skin approximately 2
body inches proximal to the medial superior border of the patella
over the quadricep muscles, such as the vastus medialis. A second
electrode 18b is positioned is electrical contact with tissue to
stimulate the patient's anterior tibialis. Most preferably, second
electrode 18b comprises a surface electrode that is positioned
anterior and inferior to the fibular head.
[0247] Another pair of electrodes 20a, 20b is provided to stimulate
the lateral leg and dorsal foot muscles and nerves. The first
electrode 20a is positioned in electrical contact with tissue to
stimulate the distal peroneal muscles. Most preferably, first
electrode 20a comprises a surface electrode that is positioned on
the patient's skin on the a point three body inches above the
lateral malleolus between the posterior border of the fibula over
the peroneus tendons. A second electrode 20b is positioned is
electrical contact with tissue to stimulate the extensor digitorum
brevis muscle and deep peroneal nerve. Most preferably, second
electrode 20b comprises a surface electrode that is positioned on
the dorsum of the foot, over the first three metatarsal bones.
[0248] During treatment, the first and second channels are
positioned on the right or left lower extremity and a patterned
pulse train is applied to the arm as discussed more fully below. It
will be appreciated that the muscles involved in arm movement may
be bilaterally stimulated when the electrical stimulation device
contains at least four channels. Alternatively, two electrical
stimulation devices can be used for bilateral stimulation: one to
simulate the right lower extremity, and one to stimulate the left
lower extremity.
[0249] In this exemplary embodiment, the pulse train pattern
comprises a low frequency pulse train pattern or a
frequency-sequenced pulse burst train pattern having the following
parameters:
Low Frequency Pulse Train Pattern:
[0250] Pulse duration of individual electrical pulses: 200
microseconds Current amplitude of individual electrical pulses:
10-50 milliamps Total treatment time: 20 minutes Total number of
treatments: 18 (over six weeks) Frequency of individual electrical
pulses (in each phase): 50 hertz
Frequency Sequenced Pulse Burst Train Pattern
Carrier Frequency: 500 Hz-100,000 Hz
[0251] First Sequence Burst Frequency: 2-20 Hz for up to 10 minutes
Second Sequence Burst Frequency: 0.1 Hz-5 Hz for up to thirty
minutes Third Sequence Burst Frequency: 20 Hz-250 Hz for up to 20
minutes Current amplitude of individual electrical pulses: 10-50
milliamps Total treatment time: up to 60 minutes Total number of
treatments: 18 (over six weeks)
[0252] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.015 mA/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the lower extremities 135c.
Eighteenth Exemplary Embodiment
[0253] In a eighteenth exemplary embodiment of the present
invention, as generally illustrated in FIG. 3R, a pair of
electrodes is positioned in electrical contact with the patient's
tissue in order to provide electrical stimulation to one or more of
the muscles associated with toe and ankle dorsiflexion (or
extension) and flexion (or plantar flexion) as a treatment for
neurological disorders afflicting the lower extremities. In
addition, at least one of a pair of electrodes is positioned in
electrical contact of the area of the cranium overlying the brain
somatosensory and motor control of the lower extremity 135c as
illustrated in FIG. 4A.
[0254] More specifically, as generally shown in FIG. 3R, a
two-channel system is used to apply electrical stimulation to
agonist/antagonist muscles involved in toe and ankle
extension/flexion. In the first channel, a first electrode 18a is
positioned is electrical contact with tissue to stimulate the motor
point of the extensor digitorum brevis muscle (which extends the
joints of the proximal phalanges of toes 1-4). Most preferably,
second electrode 18b comprises a surface electrode that is
positioned on the patient's skin at the anterior lateral mid shaft
of the leg over the mid tibialis anterior and the approximate mid
belly of the extensor digitorum longus and extensor hallicus
longus. Most preferably, first electrode 18a comprises a surface
electrode that is positioned on the patient's skin about
mid-leg.
[0255] For the second channel, a first electrode 20a is positioned
is electrical contact with tissue to stimulate the intrinsic
muscles of the foot. Most preferably, first electrode 20a comprises
a surface electrode that is positioned on the patient's skin on the
sole of the foot at the anterior one-third junction to include the
abductor hallucis. The second electrode 20b is positioned in
electrical contact with tissue to stimulate the posterior tibialis
and flexor hallicus muscles.
[0256] During treatment, the first and second channels are
positioned on the right or left leg, and a patterned pulse train is
applied to the leg as discussed more fully below. It will be
appreciated that the muscles involved in toe extension and flexion
may be bilaterally stimulated when the electrical stimulation
device contains at least four channels. Alternatively, two
electrical stimulation devices can be used for bilateral
stimulation: one to simulate the right leg, and one to stimulate
the left leg.
[0257] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
Pulse duration of individual electrical pulses: 50-70 microseconds
Current amplitude of individual electrical pulses: 30-70 milliamps
Duration of first phase: 200 milliseconds Duration of overlap
between first and second phase: 40 milliseconds Duration of second
phase: 200 milliseconds Duration of overlap between second and
third phase: 40 milliseconds Duration of third phase: 120
milliseconds Frequency of pulse train pattern: 0.67 hertz Total
treatment time: 20 minutes Total number of treatments: 18 during
six weeks Frequency of individual electrical pulses (in each
phase): 50 Hz
[0258] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.015 ma/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the lower extremities 135c. If the bilateral lower
extremities are involved, the transcranial stimulation could be
applied bilaterally with the positive electrode placed as described
in 135c on each side of the cranium and the negative electrodes
placed either on the forehead utilizing larger electrodes or on a
neutral position over the upper shoulder.
Nineteenth Exemplary Embodiment
[0259] In a nineteenth exemplary embodiment of the present
invention, generally illustrated in FIG. 3S, a pair of electrodes
is positioned in electrical contact with the patient's tissue in
order to provide electrical stimulation to one or more of the
muscles associated with ankle dorsiflexion and eversion and plantar
flexion as a treatment for neurological disorders that afflict the
lower extremities. In addition, at least one of a pair of
electrodes is positioned in electrical contact of the area of the
cranium overlying the brain somatosensory and motor control of the
lower extremity 135c as illustrated in FIG. 4A
[0260] More specifically, as shown in FIG. 3S, a two-channel system
is used to apply electrical stimulation to muscles involved in
ankle dorsillexion and plantar flexion and/or ankle inversion and
eversion. In the first channel (panel 1 of FIG. 3S), a first
electrode 18a is positioned is electrical contact with tissue to
stimulate the lower portion of the tibialis anterior muscle. Most
preferably, first electrode 18a comprises a surface electrode that
is positioned on the patient's skin over the mid belly of the
anterior tibialis. A second electrode 18b is positioned in
electrical contact with tissue to stimulate the patient's proximal
tibialis anterior muscle. Most preferably, second electrode 18b
comprises a surface electrode that is positioned on the patient's
skin inferior to the fibular head.
[0261] Alternatively, in the first channel (panel 2 of FIG. 3S), a
first electrode 18a is positioned is electrical contact with tissue
to stimulate the anterior and lateral muscles of the leg. Most
preferably, first electrode 18a comprises a surface electrode that
is positioned on the patient's skin mid belly of the anterior
tibialis as well as the peroneus muscles. A second electrode 18b is
positioned in electrical contact with tissue to stimulate the
patient's proximal tibialis anterior muscle. Most preferably,
second electrode 18b comprises a surface electrode that is
positioned on the patient's skin inferior to the fibular head.
[0262] For the second channel (panel 3 of FIG. 3S), a first
electrode 20a and second electrode 20b are positioned in electrical
contact with tissue to stimulate the patient's triceps surae. Most
preferably, first electrode 20a comprises a surface electrode that
is positioned on the patient's skin directly over the junction of
the gastroenemius and the soleus muscles. Most preferably, second
electrode 20b comprises a surface electrode that is positioned on
the patient's skin posteriorly just inferior to the popliteal fossa
over the tibial nerve and the two heads of the gastroenemius
muscle.
[0263] During treatment, the first and second channels are
positioned on the right or left leg, and a patterned pulse train is
applied to the leg as discussed more fully below. It will be
appreciated that the muscles involved in toe extension and flexion
may be bilaterally stimulated when the electrical stimulation
device contains at least four channels. Alternatively, two
electrical stimulation devices can be used for bilateral
stimulation: one to simulate the right leg, and one to stimulate
the left leg.
[0264] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern or a
functional pattern that typically creates ankle dorsiflexion and
eversion having the following parameters:
Triphasic Overlapping Pulse Train Pattern
[0265] Pulse duration of individual electrical pulses: 50-70
microseconds Current amplitude of individual electrical pulses:
30-70 milliamps Duration of first phase: 200 milliseconds Duration
of overlap between first and second phase: 40 milliseconds Duration
of second phase: 200 milliseconds Duration of overlap between
second and third phase: 40 milliseconds Duration of third phase:
120 milliseconds Frequency of pulse train pattern: 0.67 hertz Total
treatment time: 20 minutes Total number of treatments: 18 during
six weeks Frequency of individual electrical pulses (in each
phase): 50 Hz
Functional Pattern for Ankle Dorsiflexion and Eversion
[0266] Pulse duration of individual electrical pulses: 50-200
microseconds Current amplitude of individual electrical pulses:
30-140 milliamps Duration of first phase: 400 milliseconds Duration
of overlap: 250 milliseconds Duration of second phase: 250
milliseconds Frequency of pulse train pattern: 1.0 hertz Total
treatment time: up to 30 minutes Total number of treatments: 18
(over six weeks) Frequency of individual electrical pulses (in each
phase): 50 hertz
[0267] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.0.15 mA/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the lower extremities 135c.
Twentieth Exemplary Embodiment
[0268] In an twentieth exemplary embodiment of the present
invention, generally illustrated in FIG. 3T, a pair of electrodes
is positioned in electrical contact with the patient's tissue in
order to provide electrical stimulation to one or more of the
muscles associated with the lower extremities as a treatment for
neurological disorders that afflict the lower extremities. In
addition, at least one of a pair of electrodes is positioned in
electrical contact of the area of the cranium overlying the brain
somatosensory and motor control of the lower extremity 135c as
illustrated in FIG. 4A.
[0269] More specifically, as generally shown in FIG. 3T, a
two-channel system is used to apply electrical stimulation to
muscles involved in movement of the lower extremity. In the first
channel, a first electrode 18a is positioned in electrical contact
with tissue to stimulate the patient's proximal tibialis anterior
muscle. Most preferably, second electrode 18b comprises a surface
electrode that is positioned on the patient's skin inferior to the
fibular head. A second electrode 18b is positioned in electrical
contact with tissue to stimulate the midpoint of the quadriceps
muscles. In the second channel, a first electrode 20a is positioned
is electrical contact with tissue to stimulate the patient's
triceps surae. A second electrode 20b is positioned in electrical
contact with tissue to stimulate the mid hamstrings.
[0270] During treatment, the first and second channels are
positioned on the right or left leg, and a patterned pulse train is
applied to the leg as discussed more fully below. It will be
appreciated that the muscles involved in toe extension and flexion
may be bilaterally stimulated when the electrical stimulation
device contains at least four channels. Alternatively, two
electrical stimulation devices can be used for bilateral
stimulation: one to simulate the right leg, and one to stimulate
the left leg.
[0271] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
Pulse duration of individual electrical pulses: 50-100 microseconds
Current amplitude of individual electrical pulses: 30-90 milliamps
Duration of first phase: 200 milliseconds Duration of overlap
between first and second phase: 40 milliseconds Duration of second
phase: 200 milliseconds Duration of overlap between second and
third phase: 40 milliseconds Duration of third phase: 120
milliseconds. Frequency of pulse train pattern: 0.67 hertz Total
treatment time: 20 minutes Total number of treatments: 18 during
six weeks Frequency of individual electrical pulses (in each
phase): 50 Hz
[0272] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.015 ma/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the lower extremities 135c.
Twenty-First Exemplary Embodiment
[0273] In a twenty-first exemplary embodiment of the present
invention, generally illustrated in FIG. 3U, a pair of electrodes
is positioned in electrical contact with the patient's tissue in
order to provide electrical stimulation to one or more of the
muscles associated with hip abduction and knee extension as well as
hip adduction and knee flexion (stabilization) as a treatment for
neurological disorders that afflict the lower extremities. In
addition, at least one of a pair of electrodes is positioned in
electrical contact of the area of the cranium overlying the brain
somatosensory and motor control of the lower extremity 135c as
illustrated in FIG. 4A.
[0274] More specifically, as generally shown in FIG. 3U, a
two-channel system is used to apply electrical stimulation to
muscles involved in hip abduction/adduction and knee
extension/flexion. In the first channel, a first electrode 18a is
positioned is electrical contact with the quadricep muscles, and in
particular to stimulate the motor point of the vastus medialis,
which functions as an extensor of the knee. A second electrode 18b
is positioned in electrical contact with tissue to stimulate the
gluteus medius, gluteus minimus, and tensor faciae latae.
Preferably, the second electrode 18b is positioned about midway
between the iliac crest and the greater trochanter. In the second
channel, a first electrode 20a is positioned is electrical contact
with tissue to stimulate the patient's hamstring muscles (biceps
femoris, semitendinosus, and/or semimembraneous muscles) A second
electrode 20b is positioned in electrical contact with tissue to
stimulate the adductor magnus, adductor longus, adductor brevis,
and medial hamstring muscles.
[0275] The far right panel of FIG. 3U shows the hip extensor
alternative placement: In the second channel, a first electrode 20a
is positioned in electrical contact with tissue to stimulate the
adductor magnus, adductor longus, adductor brevis and medial
hamstring muscles. A second electrode 20b is positioned in
electrical contact with tissue to stimulate the mid-belly of the
gluteus maximus.
[0276] During treatment, the first and second channels are
positioned on the right or left leg, and a patterned pulse train is
applied to the leg as discussed more fully below. It will be
appreciated that the muscles involved in hip abduction/adduction
and knee extension/flexion may be bilaterally stimulated when the
electrical stimulation device contains at least four channels.
Alternatively, two electrical stimulation devices can be used for
bilateral stimulation: one to simulate the right leg, and one to
stimulate the left leg.
[0277] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
Pulse duration of individual electrical pulses: 50-200 microseconds
Current amplitude of individual electrical pulses: 30-140 milliamps
Duration of first phase: 200 milliseconds Duration of overlap
between first and second phase: 40 milliseconds Duration of second
phase: 200 milliseconds Duration of overlap between second and
third phase: 40 milliseconds Duration of third phase: 120
milliseconds Frequency of pulse train pattern: 0.67 hertz Total
treatment time: 20 minutes Total number of treatments: 18 during
six weeks Frequency of individual electrical pulses (in each
phase): 50 Hz
[0278] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.015 ma/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the lower extremities 135c. For bilateral neuromuscular
stimulation, the pattern would be biphasic and sequenced from one
extremity to the other. If the bilateral lower extremities are
involved, the transcranial stimulation could be applied bilaterally
with the positive electrode placed as described in 135c on each
side of the cranium and the negative electrodes placed either on
the forehead utilizing larger electrodes or on a neutral position
over the upper trapezius.
Twentieth-Second Exemplary Embodiment
[0279] In a twenty-second exemplary embodiment of the present
invention, generally illustrated in FIG. 3V, a pair of electrodes
is positioned in electrical contact with the patient's tissue in
order to provide electrical stimulation to one or more of the
muscles associated with knee extension and flexion as a treatment
for neurological disorders that afflict the lower extremities. In
addition, at least one of a pair of electrodes is positioned in
electrical contact of the area of the cranium overlying the brain
somatosensory and motor control of the lower extremity 135c as
illustrated in FIG. 4A
[0280] More specifically, as generally shown in FIG. 3V, a
two-channel system is used to apply electrical stimulation to
muscles involved in knee extension/flexion. In the first channel, a
first electrode 18a is positioned in electrical contact with tissue
to stimulate the rectus lemons and vastus lateralis muscles. A
second electrode 18b is positioned is electrical contact with the
vastus medialis muscles, and in particular to stimulate a motor
point of the on the vastus medialis, which functions as an extensor
of the knee. In the second channel, the electrode 20a is positioned
in electrical contact with tissue to stimulate the distal portion
of the patient's biceps femoris, semimembranosus, and/or
semitendinosus muscles. Electrode 20b is positioned in electrical
contact with tissue to stimulate the proximal portion of the
patient's biceps femoris, semimembranosus, and/or semitendinosus
muscles.
[0281] During treatment, the first and second channels are
positioned on the right or left leg, and a patterned pulse train is
applied to the leg as discussed more fully below. It will be
appreciated that the muscles involved in hip knee extension/flexion
may be bilaterally stimulated when the electrical stimulation
device contains at least four channels. Alternatively, two
electrical stimulation devices can be used for bilateral
stimulation: one to simulate the right leg, and one to stimulate
the left leg.
[0282] In this exemplary embodiment, the pulse train pattern
comprises a triphasic overlapping pulse train pattern having the
following parameters:
Pulse duration of individual electrical pulses: 50-200 microseconds
Current amplitude of individual electrical pulses: 30-140 milliamps
Duration of first phase: 200 milliseconds Duration of overlap
between first and second phase: 40 milliseconds Duration of second
phase: 200 milliseconds Duration of overlap between second and
third phase: 40 milliseconds Duration of third phase: 120
milliseconds Frequency of pulse train pattern: 0.67 hertz Total
treatment time: 20 minutes Total number of treatments: 18 during
six weeks Frequency of individual electrical pulses (in each
phase): 50 Hz
[0283] In this exemplary embodiment, a continuous direct or pulsed
direct current of approximately 1 mA with a current density of
greater than 0.015 ma/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the lower extremities 135c.
Twenty-Third Exemplary Embodiment
[0284] In a twenty-third exemplary embodiment of the present
invention, generally illustrated in FIG. 3W, a pair of electrodes
is positioned in electrical contact with the patient's tissue in
order to provide electrical stimulation to one or more of the
muscles associated with functional rehabilitation of walking,
cycling, and sit-to-stand are used as a treatment for neurological
disorders that afflict the lower extremities. In addition, at least
one of a pair of electrodes is positioned in electrical contact of
the area of the cranium overlying the brain somatosensory and motor
control of the lower extremity. In addition, at least one of a pair
of electrodes is positioned in electrical contact of the area of
the cranium overlying the brain somatosensory and motor control of
the lower extremity 135c as illustrated in FIG. 4A. Alternatively,
two pairs of electrodes may be used as illustrated in FIG. 4E
(either panel) with the negative electrode of the first channel
being placed over 135c on FIG. 4A.
[0285] More specifically, as generally shown in FIG. 3W, a
two-channel system is used to apply electrical stimulation to
muscles involved in knee extension. In the first channel, a first
electrode 18a is positioned in electrical contact with tissue to
stimulate the rectus femoris, and vastus lateralis muscles. A
second electrode 18b is positioned is electrical contact with the
vastus medialis muscles, and in particular to stimulate a motor
point of the on the vastus medians, which functions as an extensor
of the knee. In the second channel, the electrode 20a is positioned
in electrical contact with tissue to stimulate the contralateral
knee extensors on the opposite side of the body.
[0286] In this exemplary embodiment, the pulse train pattern
comprises a functional pulse train patterns having the following
parameters:
Pulse Train Pattern for Walking:
[0287] Pulse duration of individual electrical pulses: 50-100
microseconds Current amplitude of individual electrical pulses:
50-140 milliamps Duration of first phase: 240 milliseconds Duration
of delay: 260 milliseconds Duration of second phase: 240
milliseconds Frequency of pulse train pattern: 1.0 hertz Frequency
of individual electrical pulses (in each phase): 50 hertz Total
treatment time: 10 minutes Total number of treatments: 18 (over six
weeks)
[0288] The timing parameters to be adjusted for the desired speed
or cycles per minute. The current embodiment demonstrates timing
pattern for lower extremity walking at 1 Hz.
Pulse Train Pattern for Cycling:
[0289] Pulse duration of individual electrical pulses: 50-200
microseconds Current amplitude of individual electrical pulses:
50-140 milliamps Duration of first phase: 340 milliseconds Duration
of delay: 160 milliseconds Duration of second phase: 340
milliseconds Frequency of pulse train pattern: 1.0 hertz Total
treatment time: 10 minutes Total number of treatments: 18 (over six
weeks) Frequency of individual electrical pulses (in each phase):
50 hertz
[0290] The timing parameters to be adjusted for the desired speed
or cycles per minute. The current embodiment demonstrates timing
pattern for lower extremity cycling at 1 Hz.
Pulse Train Pattern for Sit-to-Stand:
[0291] Pulse duration of individual electrical pulses: 50-200
microseconds Current amplitude of individual electrical pulses:
50-140 milliamps Duration of first phase ramp: 2 seconds Duration
of first phase: 3 seconds Frequency of pulse train pattern: 0.1
hertz Total treatment time: 15 minutes Total number of treatments:
18 (over six weeks) Frequency of individual electrical pulses (in
each phase): 50 hertz
[0292] The timing parameters to be adjusted for the desired speed
or cycles per minute. The current embodiment demonstrates timing
pattern for sit-to-stand every 10 seconds. When using sit to stand
training, both channels are stimulated simultaneously.
[0293] In these exemplary embodiments, a continuous direct or
pulsed direct current of approximately 1 mA with a current density
of greater than 0.015 ma/cm.sup.2 is simultaneously applied
transcranially to the brain somatosensory and motor cortex region
controlling the lower extremities 135c as illustrated in FIG. 4A.
An alternative placement for brain stimulation is illustrated in
FIG. 4E (either panel) using a 2 channel stimulator placed in a
quadripolar arrangement with the electrode 118a being the positive
electrode applied to the brain somatosensory and motor cortex
region controlling the lower extremities 135c as illustrated in
FIG. 4A.
[0294] It will also be appreciated that the neurological disorder
treatment methods of the present invention may readily be adapted
by configuring the electrodes in a manner that is asymmetrical or
bilateral in nature. For example, a combination of the Fifth and
Seventh exemplary embodiments may be used. It is contemplated that
all of the Exemplary embodiments may be combined in a similar
manner to fit the patient's needs and symptoms (e.g. first
embodiment for the first channel and either the second, third,
fourth, fifth, sixth, or seventh embodiments for the second
channel, and so on).
[0295] Case Study #1
[0296] This case study involved a 67 year-old female four months
following a stroke affecting the left side of her body. She was
unable to move her left hand at all voluntarily and required
considerable effort by the therapy staff to move her fingers
passively. After stretching, her hand moved rapidly back into full
flexion of the fingers and thumb. The thumb had developed a flexion
contracture. She had no voluntary supination and maintained the
wrist at about 45 degrees of pronation. She had undergone three
weeks of daily in-patient therapy beginning one week after the
stroke and twice weekly outpatient therapy which involved
stretching and facilitation techniques without success for the
three months before this treatment program.
[0297] The patient was first treated with a transcranial constant
direct current stimulator with the positive electrode (30 cm.sup.2)
was positioned to the right scalp overlying the brain somatosensory
and motor region for the hand and upper extremity. The negative
electrode (22 cm.sup.2) was positioned over the left shoulder
muscle as a neutral location. After applying transcranial direct
current stimulation for ten minutes at 1.0 mA of constant direct
current, the peripheral stimulation program began as described
below.
[0298] During the patient experienced a very slight tingling
sensation under both the positive and negative electrodes of the
transcranial stimulator. No adverse effects were noted. The total
treatment time for the transcranial stimulation was about 30
minutes.
[0299] After about 10 minutes, the patient was treated with
Omnistim.RTM. FX.sup.2 electrical stimulation with a therapy
protocol described as the "upper extremity tri-phasic" with channel
A negative (2''.times.4'') electrode applied to the forearm flexors
and the positive (2''.times.4'') electrode applied to the hand
intrinsics. Channel B applied to the forearm wrist and finger
extensors with the negative (2''.times.4'') electrode applied to
the proximal forearm muscles and the positive (2''.times.4'')
electrode applied to the distal forearm muscles. Electrode
placements and protocol follow description is the twelfth exemplary
embodiment.
[0300] The intensity of the peripheral stimulation was increased to
create minimal twitch muscle contractions with visible activation
and minimal linger and wrist movement. The pulse train timing
pattern comprises a triphasic overlapping pulse train pattern
having the following parameters:
Phases one and three are applied through channel A Phase two is
applied through channel B Pulse duration of individual electrical
pulses: 50 microseconds Current amplitude of individual electrical
pulses: 60-90 milliamps Duration of first phase: 100 milliseconds
(5 pulses per train) Duration of overlap: 20 milliseconds (1 pulse)
Duration of second phase: 100 milliseconds (5 pukes per train)
Duration of third phase: 60 milliseconds (5 pulses per train)
Duration of overlap of third phase over second phase: 20
milliseconds (1 pulse) Frequency of pulse train pattern: 1.5
seconds (0.67 Hz) Total treatment time: 20 minutes for the
peripheral stimulation Frequency of individual electrical pulses
(in each phase): 50 hertz
[0301] Following the combination of the transcranial direct current
stimulation and the peripheral patterned stimulation, the patient
stated that her hand felt somewhat more "normal," especially in the
ulnar distribution. She was able to move her thumb through a
partial flexion and extension range of motion of 45 degrees with
voluntary effort but extension was inhibited by muscle contracture.
All four fingers demonstrated immediate functional improvement with
voluntary movement from initial position of full flexion to
extension lacking only the last 20 degrees of metacarpal-phalangeal
(MP) joint motion and 10 degrees of proximal inter phalangeal (PIP)
joint motion. This motion was able to be repeated voluntarily and
was maintained with only partial loss of range of motion.
[0302] At follow-up in 12 weeks she was still able to extend the
fingers but declined to minus 45 degrees of MP extension but
improved PIP extension to full range. A single repeat combination
stimulation again improved her voluntary finger extension to minus
20 degrees MP motion. The maneuver was considerably faster taking
only 1-2 seconds following this procedure. After the first
procedure the finger extension through the same range took 4
seconds. She was also able to supinate the forearm to neutral.
[0303] Case Study #2
[0304] The second case study involves an 81 year-old male who
suffered a stroke 34 years ago and who had not regained any
voluntary movement of his left hand. He had sustained a right
middle cerebral artery infarct at the time. Despite therapies, he
had no voluntary return of movement to the wrist and hand. He had
some shoulder and elbow motion. He was able to stretch the fingers
and thumb using his right hand. He was not able to generate even a
minimal voluntary twitch of any digit of the hand.
[0305] The patient was first treated with a transcranial constant
direct current stimulator with the positive electrode (30 cm.sup.2)
was positioned to the right scalp overlying the brain motor region
for the hand and upper extremity. The negative electrode (22
cm.sup.2) was positioned over the left shoulder muscle as a neutral
location. After applying transcranial direct current stimulation
for ten minutes at 1.0 mA of constant direct current, the
peripheral stimulation program began as described below.
[0306] During the treatment, patient experienced a very slight
tingling sensation under both the positive and negative electrodes
of the transcranial stimulator. No adverse effects were noted. The
total treatment time for the transcranial stimulation was about 30
minutes.
[0307] After about 10 minutes, the patient was treated with
Omnistim.RTM. FX.sup.2 electrical stimulation with a therapy
protocol described as the "upper extremity tri-phasic" with channel
A negative (2''.times.4'') electrode applied to the forearm flexors
and the positive (2''.times.4'') electrode applied to the hand
intrinsics. Channel B applied to the forearm wrist and finger
extensors with the negative (2''.times.4'') electrode applied to
the proximal forearm muscles and the positive (2''.times.4'')
electrode applied to the distal forearm muscles. Electrode
placements and protocol follow description is the twelfth exemplary
embodiment.
[0308] The intensity of the peripheral stimulation was increased to
create minimal twitch muscle contractions with visible activation
and minimal finger and wrist movement. The pulse train timing
pattern comprises a triphasic overlapping pulse train pattern
having the following parameters:
Phases one and three are applied through channel A Phase two is
applied through channel B Pulse duration of individual electrical
pulses: 50 microseconds Current amplitude of individual electrical
pulses: 60-90 milliamps Duration of first phase: 100 milliseconds
(5 pulses per train) Duration of overlap: 20 milliseconds (1 pulse)
Duration of second phase: 100 milliseconds (5 pulses per train)
Duration of third phase: 60 milliseconds (5 pulses per train)
Duration of overlap of third phase over second phase: 20
milliseconds (1 pulse) Frequency of pulse train pattern: 1.5
seconds (0.67 Hz) Total treatment time: 20 minutes for the
peripheral stimulation Frequency of individual electrical pulses
(in each phase): 50 hertz
[0309] Following 20 minutes of neuromuscular stimulation combined
with 30 minutes of the transcortical direct current stimulation
with the positive placed over the right brain motor cortex
approximating the hand region and the negative placed over the left
side of the patient's upper shoulder, he was able to produce only
most minimal but definite voluntary minimal twitch of the thumb but
not any of the other fingers and the thumb movement lasted only
about 15 minutes after the first stimulation program was
completed.
[0310] Following a second session of the same combined stimulation
protocol five days later, the patient was now able to produce
voluntary movement of the thumb through a 45 degree range of motion
and the fingers beginning at full flexion through 60 degrees of
extension with equal motion at MP joints and the PIP joint. That
was the first time he was able to move his fingers in the last 34
years.
[0311] This improvement lasted greater than 12 weeks with continued
voluntary exercise. He also noted an improvement in the sensation
of his hand.
[0312] Case Study #3
[0313] The third case example involves a 69 year-old male who
sustained a left sided cerebrovascular accident resulting in right
hemiparesis about nine months prior to the combined stimulation
treatment. He had regained speech and swallowing but continues to
have difficulty with ambulation and arm movement despite extensive
rehabilitation therapies three times per week for the full nine
months. He even had multiple sessions of the below noted FX2
electrical stimulation therapy without improvement.
[0314] The patient was first treated with a transcranial constant
direct current stimulator with the positive electrode (30 cm.sup.2)
was positioned to the right scalp overlying the brain motor region
for the left lower extremity. The negative electrode (22 cm.sup.2)
was positioned over the left upper trapezius muscle as a neutral
location. After applying transcranial direct current stimulation
for ten minutes at 1.0 mA of constant direct current, the
peripheral stimulation program began as described below.
[0315] The patient was treated with OMNISTIM.RTM. FX2 electrical
stimulation with a therapy protocol described as the "lower
extremity tri-phasic" with channel. A negative (3''.times.5'')
electrode applied to the anterior lateral hip musculature and the
positive (3''.times.5'') electrode applied to the vastus medialis
just medial and superior to the knee. Channel B applied to
posterior hip and thigh with the negative (3''.times.5'') electrode
applied to the gluteus maximus muscle and the positive
(3''.times.5'') electrode applied to the medial aspect of mid
hamstring muscles and hip adductors as described in the
twenty-first exemplary embodiment with FIG. 3U (panel 2).
[0316] The intensity of the peripheral stimulation was such to
create moderate muscle contractions that were well tolerated.
[0317] The pulse train timing pattern comprises a triphasic
overlapping pulse train pattern having the following
parameters:
Phases one and three are applied through channel A Phase two is
applied through channel B Pulse duration of individual electrical
pulses: 70 microseconds Current amplitude of individual electrical
pulses: 60-100 milliamps Duration of first phase: 200 milliseconds
Duration of overlap: 40 milliseconds Duration of second phase: 200
milliseconds Duration of third phase: 120 milliseconds Duration of
overlap of third phase over second phase: 40 milliseconds Frequency
of pulse train pattern: 1.5 seconds (0.67 Hz) Total treatment time:
20 minutes for the peripheral stimulation Frequency of individual
electrical pulses (in each phase): 50 hertz Phases one and three
are applied through channel A
[0318] After the first two sessions of transcranial direct current
stimulation applied to the scalp overlying the left vertex
corresponding to the motor strip region of the brain and EMG
patterned electrical stimulation to the thigh and leg muscles
quadriceps, hamstrings, and gastroc--the patient showed no
significant improvement in gait. As discussed above, the positive
electrode location was initially over the lower extremity motor
cortex at the left vertex but after the first two unsuccessful
treatments, it was shifted laterally one cm posterior-laterally in
an attempt to decrease the stimulation to the contralateral motor
cortex.
[0319] The third session was a modification of the first two in
which the transcranial application was moved one centimeter
laterally away from the vertex and the peripheral stimulation was
applied to the hip and thigh musculature as demonstrated in the
twenty-first exemplary embodiment. Following 30 minutes of
transcranial DC stimulation at 1 mA with 20 minutes of peripheral
stimulation, the patient was able to again, transfer without
assistance but his gait speed improved considerably. Before the
third stimulation session, his shuttle walking took 29 seconds and
repeated at 29 seconds tested 2 days prior and again just before
the stimulation. Following the stimulation he was timed at 22
seconds and repeated at 22 seconds. Hip flexion and knee flexion
improved to 30 degrees and he subjectively felt better balance.
[0320] Five days later, his gait had slowed to 25 seconds. After a
fourth stimulation session using the same modified system of the
third session, his shuttle time improved to 20 seconds average (21
and 19 seconds). He again noted a subjective improvement in
balance. Normal fast gait for the same shuttle tested out to be 10
seconds. The improvement in gait and balance continued after 5 more
days.
[0321] While the present invention has been described and
illustrated hereinabove with reference to several exemplary
embodiments, it should be understood that various modifications
could be made to these embodiments without departing from the scope
of the invention. Therefore, the invention is not to be limited to
the exemplary embodiments described and illustrated hereinabove,
except insofar as such limitations are included in the following
claims.
* * * * *