U.S. patent application number 16/839240 was filed with the patent office on 2020-07-23 for method and apparatus for treating various neurological conditions.
The applicant listed for this patent is Stefanie LATTNER. Invention is credited to Stefanie LATTNER.
Application Number | 20200230020 16/839240 |
Document ID | / |
Family ID | 46457711 |
Filed Date | 2020-07-23 |
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United States Patent
Application |
20200230020 |
Kind Code |
A1 |
LATTNER; Stefanie |
July 23, 2020 |
METHOD AND APPARATUS FOR TREATING VARIOUS NEUROLOGICAL
CONDITIONS
Abstract
Disclosed herein is a method and apparatus for treating
neurological conditions such as attention deficit disorder, autism,
and Parkinson's disease. More particularly, the invention relates
to methods and apparatus used to stimulate the 8.sup.th cranial
nerve, particularly for treatment of such diseases and
disorders.
Inventors: |
LATTNER; Stefanie;
(Rockledge, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
LATTNER; Stefanie |
Rockledge |
FL |
US |
|
|
Family ID: |
46457711 |
Appl. No.: |
16/839240 |
Filed: |
April 3, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13978298 |
Jul 3, 2013 |
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PCT/US2012/020315 |
Jan 5, 2012 |
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16839240 |
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61430040 |
Jan 5, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 21/00 20130101;
A61M 2021/0022 20130101; A61M 21/02 20130101; A61H 2201/165
20130101; A61H 2205/027 20130101; A61H 2230/405 20130101; A61H
2201/5097 20130101; A61M 2205/50 20130101; A61H 2201/1604 20130101;
A61H 2230/065 20130101; A61M 2021/0072 20130101; A61H 2230/305
20130101; A61H 2230/505 20130101; A61H 2201/5002 20130101; H04R
2460/13 20130101; A61H 23/0245 20130101; A61H 23/00 20130101; A61M
2021/0027 20130101 |
International
Class: |
A61H 23/00 20060101
A61H023/00; A61H 23/02 20060101 A61H023/02; A61M 21/00 20060101
A61M021/00 |
Claims
1. A method for treating a neurological disorder, the method
comprising: mechanically stimulating both auditory and vestibular
nerve bundles of a vestibulocochlear nerve of a patient, wherein
the stimulation comprises a first mechanical vibratory stimulus for
mechanically stimulating the auditory nerve bundle of the
vestibulocochlear nerve and a second mechanical vibratory stimulus
for mechanically stimulating the vestibular nerve bundle of the
vestibulocochlear nerve, wherein the mechanical vibratory stimuli
vibrate at different frequencies and are applied simultaneously by
a vibrating mechanism externally applied to the patient, and
wherein the mechanical vibratory stimuli are achieved by
application of a mechanical force.
2. The method of claim 1, wherein the mechanical vibratory stimuli
are applied to both vestibulocochlear nerves of the patient.
3. The method of claim 1, wherein at least one of the mechanical
vibratory stimuli is applied at a frequency of about 0.1 Hz to
about 40 Hz.
4. The method of claim 1, wherein at least one of the mechanical
vibratory stimuli is applied at a frequency of about 0.3 Hz to
about 15 Hz.
5. The method of claim 4, wherein the second mechanical vibratory
stimulus is applied at a frequency of about 0.3 Hz to about 15
Hz.
6. The method of claim 1, wherein the first mechanical vibratory
stimulus is applied to the auditory nerve bundle of the
vestibulocochlear nerve, without affecting the vestibular nerve
bundle of the vestibulocochlear nerve.
7. The method of claim 1, wherein the second mechanical vibratory
stimulus is applied to the vestibular nerve bundle of the
vestibulocochlear nerve, without affecting the auditory nerve
bundle of the vestibulocochlear nerve.
8. A method of increasing concentration, the method comprising:
mechanically stimulating both auditory and vestibular nerve bundles
of a vestibulocochlear nerve of a patient, wherein the stimulation
comprises a first mechanical vibratory stimulus for mechanically
stimulating the auditory nerve bundle of the vestibulocochlear
nerve and a second mechanical vibratory stimulus for mechanically
stimulating the vestibular nerve bundle of the vestibulocochlear
nerve, wherein the mechanical vibratory stimuli are applied
simultaneously by a vibrating mechanism externally applied to the
patient to increase Beta brain wave activity, and wherein the
mechanical vibratory stimuli are achieved by application of a
mechanical force.
9. A method of enhancing relaxation, the method comprising:
mechanically stimulating both auditory and vestibular nerve bundles
of a vestibulocochlear nerve of a patient, wherein the stimulation
comprises a first mechanical vibratory stimulus for mechanically
stimulating the auditory nerve bundle of the vestibulocochlear
nerve and a second mechanical vibratory stimulus for mechanically
stimulating the vestibular nerve bundle of the vestibulocochlear
nerve, wherein the mechanical vibratory stimuli are applied
simultaneously by a vibrating mechanism externally applied to the
patient to increase alpha brain wave activity, and wherein the
mechanical vibratory stimuli are achieved by application of a
mechanical force.
10. An apparatus for delivering a mechanical stimulus to the
vestibulocochlear nerve of a patient, the apparatus comprising: at
least one mechanical vibratory element capable of delivering a
complex mechanical vibration to the vestibulocochlear nerve,
wherein the complex mechanical vibration comprises a first
mechanical vibratory stimulus between about 0.1 Hz and about 40 Hz,
and a second mechanical vibratory stimulus between about 0.3 Hz and
about 15 Hz, wherein the mechanical vibratory element is externally
applied to the patient, and wherein the mechanical vibratory
stimuli are achieved by application of a mechanical force; and a
microprocessor, operatively coupled to the vibratory element for
controlling the delivery of stimuli via the at least one mechanical
vibratory element.
11. The apparatus of claim 10, further comprising a second
mechanical vibratory element capable of delivering a complex
mechanical vibration to another vestibulocochlear nerve of the
patient comprising a first mechanical vibratory stimulus between
about 0.1 Hz and about 40 Hz, and a second mechanical vibratory
stimulus between about 0.3 Hz and about 15 Hz, wherein the second
mechanical vibratory element is externally applied to the patient
and wherein the at least one mechanical vibratory element and the
second mechanical vibratory element are independently controllable
by the microprocessor.
12. The apparatus of claim 10, further comprising user controls for
selective control of the stimuli.
13. The apparatus of claim 10, wherein the at least one mechanical
vibratory element is adapted for placement externally behind the
ear of a patient.
14. The apparatus of claim 11, wherein the first and second
mechanical vibratory elements are adapted for placement externally
behind the ear of a patient.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This continuation patent application claims priority to U.S.
patent application Ser. 13/978,298, filed on Jul. 3, 2013, which
claims priority PCT Patent Application No. PCT/US2012/20315 filed
on Jan. 5, 2012, which claims priority to U.S. Provisional Patent
Application No. 61/430,040 filed on Jan. 5, 2011, in the name of
Stefanie Lattner entitled "Method and Apparatus for Treating
Various Neurological Conditions", which are hereby incorporated by
reference in their entirety.
FIELD
[0002] The present invention relates to a method and apparatus for
treating neurological conditions such as attention deficit
disorder, autism, and Parkinson's disease. More particularly, the
invention relates to methods and apparatus used to stimulate the
8.sup.th cranial nerve, particularly for treatment of such diseases
and disorders.
BACKGROUND OF INVENTION
[0003] The 8.sup.th cranial nerve is comprised of the auditory
nerve and the vestibular nerve which are adjacent to each other.
Fibers of the vestibular nerve are excited (fire) at different
frequencies than the auditory nerve. See FIG. 1 for a diagram of
the brain and the location of the 8.sup.th cranial nerve.
[0004] Previous devices have been focused on specific designs that
uniquely stimulate either the auditory nerve or the vestibular
nerve for the purpose of hearing or balance respectively and
without interfering with the other. For example, vestibular
stimulators were designed to stimulate the vestibular bundle while
not creating any auditory affects (i.e. create the sensation of
rocking without the device causing any noise, pinging, buzzing, or
other unwanted auditory excitation); while cochlear implants are
designed to stimulate the auditory nerve without effecting the
vestibular nerve (excite the nerve fibers of the auditory bundle
without causing vertigo).
[0005] Previous vestibular stimulation devices were designed to
cause an end-effect that results in sleepiness and even sleep.
Thus, such devices were specifically designed to be worn during
sleep, and need not concern themselves with wake-time activities
such as vision and coordination of movement while awake. Other such
devices were designed to induce the sensation of rocking.
[0006] Previous devices for stimulation of either the auditory
nerve or the vestibular nerve accomplished stimulation through
electrical transduction. Prior devices employed the use of
electrodes as the primary mechanism to influence the targeted
nerve. These devices deliver electrical energy in or near the head
for the purpose of stimulating nerves. Such electrical devices
inherently contain safety risks as electrical energy is delivered
directly to brain tissue and can be difficult to contain as it (by
definition) will change the electrical potential of all cells
within a certain distance and time of administration. If the
electrical energy is not adequately contained or if it is delivered
at the wrong amplitude or frequency, tissue damage may result.
[0007] These devices simply were not capable of or designed to
treat the disorders contemplated herein. Accordingly, there is a
need for a method and device capable of stimulating both the
vestibular and the auditory nerves, particularly for treatment of
neurological disorders such as attention deficit disorder, autism,
and Parkinson's disease.
SUMMARY OF THE INVENTION
[0008] Some embodiments provide a method for treating a
neurological disorder, the method comprising applying at least one
stimulus to the vestibulocochlear nerve of a patient in need of
such treatment, wherein the at least one stimulus is an auditory
stimulus, a vibratory stimulus, or a combination thereof In some
instances, both auditory stimulus and vibratory stimulus are
applied. In some instances, the at least one stimulus is applied to
one of the vestibulocochlear nerves in others, it may be applied to
both vestibulocochlear nerves.
[0009] In some embodiments, the auditory stimulus is applied at a
frequency of about 0.1 Hz to about 40 Hz.
[0010] In some embodiments, the vibratory stimulus is applied at a
frequency of about 0.3 Hz to about 15 Hz.
[0011] In some embodiments, an auditory stimulus is applied to each
vestibulocochlear nerve at different frequencies.
[0012] In some embodiments, an auditory stimulus is applied to an
auditory nerve bundle of the vestibulocochlear nerve, without
affecting a vestibular nerve bundle.
[0013] In some embodiments, a vibratory stimulus is applied to a
vestibular nerve bundle, without affecting an auditory nerve
bundle.
[0014] In some embodiments, the at least one stimulus is applied
externally and travels to the vestibulocochlear nerve via
transmission through body tissues
[0015] In some embodiments, the at least one stimulus is applied
within the patient's body and transmitted either directly to the
vestibulocochlear nerve or via transmission through body
tissues.
[0016] Some embodiments provide a method of increasing
concentration, the method comprising applying at least one stimulus
to the vestibulocochlear nerve of a patient in need of such
treatment, wherein the at least one stimulus is an auditory
stimulus, a vibratory stimulus, or a combination thereof, and
causes an increase in Beta brain wave activity.
[0017] Some embodiments provide a method of enhancing relaxation,
the method comprising applying at least one stimulus to the
vestibulocochlear nerve of a patient in need of such treatment,
wherein the at least one stimulus is an auditory stimulus, a
vibratory stimulus, or a combination thereof, and causes an
increase in alpha brain wave activity.
[0018] Some embodiments provide an apparatus for delivering a
stimulus to the vestibulocochlear nerve of a patient, the apparatus
comprising at least one vibratory element adapted capable of
delivering auditory stimulus between 0.1 Hz and about 40 Hz,
vibratory stimulus between about 0.3 Hz and about 15 Hz, or both;
and a microprocessor, operatively coupled to the vibratory element
for controlling the delivery of stimuli via the at least one
vibratory element.
[0019] Some embodiments further comprise a second vibratory element
adapted capable of delivering auditory stimulus between 0.1 Hz and
about 40 Hz, vibratory stimulus between about 0.3 Hz and about 15
Hz, or both, wherein the at least one vibratory element and the
second vibratory element are independently controllable by the
microprocessor.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] FIG. 1A is a depiction of the human brain, showing various
parts, including the vestibulocochlear nerve (i.e. the 8.sup.th
cranial nerve).
[0021] FIG. 1B depicts the human brain, showing the various
portions or lobes of the brain.
[0022] FIG. 2 is a schematic drawing of a device according to some
embodiments.
[0023] FIG. 3 is a graphical representation of a device according
to some embodiments.
[0024] FIG. 4 is a graphical representation of an alternative
device according to some embodiments.
[0025] FIG. 5A is a graphical representation of an alternative
device according to some embodiments employing a headset type
arrangement and external vibrating elements.
[0026] FIG. 5B is a graphical representation of an alternative
device according to some embodiments employing a headset type
arrangement and ear bud type vibrating elements.
[0027] FIG. 6A is a graphical representation of an alternative
device according to some embodiments employing a wearable device
arrangement and external vibrating elements.
[0028] FIG. 6B is a graphical representation of an alternative
device according to some embodiments employing a wearable device
arrangement and ear bud type vibrating elements.
[0029] FIG. 7A is a graphical representation of an alternative
device according to some embodiments employing a remote transmitter
and external vibrating elements.
[0030] FIG. 7B is a graphical representation of an alternative
device according to some embodiments employing a remote transmitter
and ear bud type vibrating elements.
[0031] FIGS. 8A and 8B show two arrangement both employing both
external vibrating elements and ear bud type vibrating
elements.
[0032] FIGS. 9 and 10 show a self-contained device in accordance
with some embodiments, affixed either externally to the back of the
ear, or within the ear canal.
[0033] FIG. 11 shows a minimally invasive device, including
potential attachment sites.
[0034] FIG. 12 depicts a schematic of an implantable device
according to some embodiments.
[0035] FIG. 13 depicts possible implantation sites.
[0036] FIGS. 14-17 are EEG readouts under various testing
conditions.
DETAILED DESCRIPTION OF THE INVENTION
[0037] It is believed that through optimal stimulation of the
entire vestibulocochlear nerve (not just the vestibular bundle or
auditory bundle) the devices described herein can be used to treat
a variety of neurological disorders, such as, but not limited to
attention deficit disorder, autism, and Parkinson's disease. Fibers
of the vestibular nerve fire at different frequencies than the
auditory nerve, so the stimulator incorporates techniques that
optimally trigger and sustain the correct stimulation of both sets
of nerve fibers which requires sophisticated coupling and
sensitivity to the desired vs. undesired end effects.
[0038] Some embodiments of the invention are designed to cause an
end-effect that, rather than inducing sleepiness, increases
concentration (which may be an excitatory effect in the
brain--particularly when targeted at treating ADHD). Similarly with
autism, stimulation may increase neuronal development,
interconnections and/or improve synchrony, all of which are
believed to be lacking in patients suffering from autism.
[0039] Some embodiments of the invention are based on mechanical
vibration, and is consequently safer than previous devices and
methods employing electrical transmissions. The mechanical
vibration will not change the electrical potential of all cells
within the area and will only affect those cells capable of
mechanical transduction.
[0040] This invention is designed to stimulate the 8.sup.th cranial
nerve, the vestibulocochlear nerve, for the purpose of treating
debilitating effects of ADD, autism, Parkinson's, etc. including
anxiety, lack of concentration, lack of motor control, and
hyperactivity.
[0041] As described above, the vestibulocochlear nerve is a sensory
nerve that comprises the auditory branch and the vestibular branch.
It transduces external information into neuronal signals that the
brain then integrates, processes, and reacts to. As is well known,
the nerve branches that comprise the vestibulocochlear nerve are
predominantly responsible for hearing and balance. However, the
neural pathways of this sensory neuron further connect to the
thalamus and cortex through complex interactions that are under
investigation, but not fully understood. It is suspected that these
sensory inputs may have the ability to influence memory, emotion,
concentration, etc. Anatomically there exists evidence that the
portions of the vestibulocochlear nerve connects with areas of the
brain indicated in each of the disorders mentioned including the
temporal lobe, frontal lobe, and the cerebellum through the
thalamus in in the case of the vestibular projections, directly to
the cerebellum. The vestibular projections are also known to
communicate with the extraoccular motor nuclei, comprising the
vestibulo-occular reflex which stabilizes vision and balance. This
neural reflex also directly communicates with the cerebellum for
motor control. The exact neural interactions per each disorder of
interest, however, is not yet known.
[0042] Key neurotransmitters that are under investigation with
respect to these disorders, namely, but not exclusively, dopamine
and seratonin are also indicated in early animal studies as being
modulators of the vestibulocochlear nerve. While the neurobiology
of this invention is not well understood due to the early nature of
the scientific community's understanding of the neurobiology of the
brain, it is believed that stimulating this nerves through
artificial means such as the device described herein, influences
the key neurotransimitters in a way that results in the desired
clinical end-effect.
[0043] FIG. 2 shows a basic schematic of a device 10 in accordance
with one embodiment of the invention.
[0044] Unlike prior devices for stimulating the vestibulocochlear
nerve:
[0045] The device is not intended to stimulate the auditory branch
of this nerve for the purpose of effecting hearing.
[0046] The device is not intended to stimulate the vestibular
branch of this nerve for the purpose of effecting balance or to
create a sensation of rocking.
[0047] Both of these nerve branches optimally fire at different
frequencies (discussed in the device description below). The device
is designed to optimally stimulate the 8.sup.th cranial nerve (both
branches) while not stimulating any neighboring nerves (such as the
facial nerve).
[0048] The auditory bundle is integrated in the brain using
contralateral control (opposite side), while the vestibular portion
of the nerve is controlled on the ipsilateral side (same side). The
delivery of stimulus and the reaction to that stimulus is complex.
The invention described herewith comprised techniques to address
this complexity by optimizing each type of stimulus needed and
optimally combining them if and when needed.
[0049] The device 10 employs a vibrating mechanism 20 to
mechanically stimulate the nerves, a control module 100, which can
include a microprocessor 110, optional user controls 120, and a
power source, such as a battery 130. The vibrating mechanism 20 can
be any suitable mechanism known or later developed in the art. Some
exemplary vibrating mechanisms include but are not limited to
"coin" or "pancake" vibration motors, ceramic devices, piezo
actuators, puffers (for air or liquid), etc.
[0050] In some embodiments, the device is an electromechanical
device that comprises an embedded microprocessor/controller that
causes contacts to vibrate at a predetermined force and frequency
to stimulate the 8.sup.th cranial nerve as described herein. The
device can be designed to be completely non-invasive device, a
minimally invasive device, or fully implantable device.
[0051] The device delivers a complex vibration (comprised of
specifically selected frequencies) that is capable of optimally
stimulating each bundle of the nerve, without stimulating
neighboring nerves.
[0052] The device stimulates the nerve without delivering
electrical energy (greatly improving the safety profile of the
device).
[0053] The device is designed so that when built in the
non-invasive form, is capable of securing to the back of the ear at
the junction of the cranial bone and mandible.
[0054] The device comprises a microprocessor for controlling the
selection of frequencies to be delivered, as well as the delivery
thereof, as well as one or more vibratory mechanisms, and in some
embodiments at least 2 vibratory mechanisms. The vibratory
mechanism(s) are operatively coupled to the microprocessor which
may be powered by a battery or other power source. The device may
also be provided with a user interface and controls for powering
the device on or off, and other controls.
[0055] The device can be constructed in a number of ways and may
employ various existing or later developed vibrator mechanisms.
[0056] In some non-invasive embodiments, the following options may
be employed. Particularly, the vibratory mechanism can be located
in the ear canal, and/or behind the ear at the junction of cranium
and jaw line. The mechanism of vibration can be achieved by
creating changes in air pressure, applying a mechanical force,
pulsation of fluid (encapsulated water, air, saline, etc.), or a
combination of the above. To secure the mechanism behind the ear
any suitable material may be used, including but not limited to a
gel pillow (or any soft material that transfers the vibration at
the desired frequency), a spring-loaded actuator, a skin-friendly
sticky pad, or any combination of the above. Some devices are
adapted for insertion into the ear canal, these include but are not
limited to a bladder filled with air, gel, saline, soft silicone,
or similar with vibrating element embedded, a probe fitted to the
ear canal that channels pulsating air, saline, or similar (as a
mechanism for transducing the selected frequency). In some
embodiments, a combination of both in the ear canal and externally
applied vibratory mechanisms can be employed.
[0057] The device can either be controlled automatically via the
microprocessor or allow for user control of any of a variety of
options. For example, the microprocessor/controller may be
Time-based: For example, on for X minutes with an intentional
off-period to control therapy time. In other embodiments, it can be
User-controlled where the user has the option to turn on the device
on an as-needed basis (with limits programmed to prevent any
potential over-usage). The control may be staged, cycling the user
through various stages in order to obtain the desired end effect.
For example, you might start with one frequency mix for a specified
duration and then adapt either over a fixed time, by user control,
by algorithmic adaptation or adaptation based on physiological
input/monitoring.
[0058] In some embodiments, the user's physiological condition or
response can be used to control the device. Any physiological
condition or combination thereof could be used to control the
device or to determine how to control the device, including but not
limited to heart rate, blood pressure, pulse, temperature,
respiration, neurotransmitters such as serotonin, blood-based
biomarkers, ear-fluid-based biomarkers, selectable
therapy/frequencies for specific conditions. Delivery of
therapy/frequencies via a programmed algorithm that controls
spatial and temporal separation so that the brain can adequately
interpret and react to the stimulus may also be used. There is also
a diagnostic option for titration or for separate application.
[0059] Stimulus Options:
[0060] The auditory and vibratory stimuli applied can be
administered independently or combined, depending on the specific
treatment approach. Specific frequencies can be tailored to each
nerve bundle and then combined, if desired.
[0061] Suitable Preferred frequencies ranges include:
[0062] Vestibular Bundle: 0.1 Hz-15 Hz
[0063] Auditory bundle: 0.3 Hz-40 Hz (through any of the methods
listed below)
[0064] Carrier frequency: 20 Hz-20 KHz (audible range)
[0065] Carrier frequency with specified frequencies for vestibular
and auditory bundle combined.
[0066] Methods to administer stimulus to auditory stimulus:
[0067] Administer the desired frequency in one ear only.
[0068] Administer 2 stimuli to each ear such that the difference is
the desired stimulus.
[0069] Frequency modulation (in terms of phase-modulation and
optimizing harmonics) or in terms of the specific frequency
chosen.
[0070] Force of vibration of air/fluid component (which could be
considered amplitude modulation).
[0071] Preferred range: 0-90 dB
[0072] Force of vibration to skin-connecting elements: any range
considered tolerable for wearing for longer durations.
[0073] Combination of any of the above.
[0074] Preferred embodiment:
[0075] Vestibular Stimulus delivered behind the ear with both
vibrating elements tuned to 0.2-0.4 Hz. Plus
[0076] Auditory stimulus also delivered behind the ear through a
secondary vibratory element tuned such that one element vibrates at
80 Hz on one ear and the second at 40 Hz on the other ear. (So that
all are below what is typically considered the auditory range).
[0077] Note: This represents only one example and is not meant to
limit the potential options listed within.
[0078] Depending upon the chosen features, particularly whether
behind the ear or in the ear or both, the device can be constructed
in a number of ways. For example, as seen in FIG. 3, a
spring-loaded articulating arm 200 that positions the pad
containing the vibrating mechanism 20 correctly and maintains
contact with the skin with the correct amount of pressure can be
employed. The microprocessor/controller 100 and battery can be
directly connected to pad with the actuator on
microprocessor/controller 100.
[0079] In some embodiments, the device is adapted for use with both
ears. In others, the device may be employed for one ear only
(either ear) as shown in FIG. 4.
[0080] In some embodiments, an adhesive/sticky fixation may be used
rather than spring-loading. Other suitable fasteners will be known
to those of skill in the art.
[0081] In some embodiments, the microprocessor/controller and
actuator are located on headset (shown with multiple fixating
mechanisms), as seen in FIG. 5. FIG. 5 also depicts an embodiment
employing the vibrating mechanism as an ear bud 20a, or other
ear-canal device.
[0082] In some embodiments, the microprocessor/controller and
actuator are located on wearable, connecting device (shown with
multiple fixation methods), as seen in FIG. 6.
[0083] In some embodiments, the microprocessor/controller and
actuator are located on a remote transmitting device (shown with
multiple fixation methods), as seen in FIG. 7.
[0084] A dual vibrating mechanism may be employed is some
embodiments above. FIG. 8 shows an exemplary embodiment.
[0085] In some embodiments, exemplified in FIGS. 9 and 10, the
device 10a is completely self-contained and fixed to the back of
the ear or within ear canal.
[0086] In some embodiments, the device is a minimally invasive, as
shown in FIG. 11, employing a small injection for placement of
vibrating element under the skin. The microprocessor/controller and
actuator can be mounted externally as described above or in any
suitable manner.
[0087] If transmitter is not used, the vibrating element may be
connected via external skin contact.
[0088] In some embodiments, the device is implantable as shown in
FIG. 12. In these embodiments, the device is located completely, or
substantially completely, under the skin. Locations for the
vibrating element 20 are similar to those described above for the
minimally invasive device, but in these embodiments, the
microprocessor/controller could also be implanted. The circles in
FIG. 13 show exemplary locations for the vibrating element.
Location of microprocessor/controller could be in soft tissue space
and hard-wired to the vibrating element.
[0089] Also contemplated herein are methods of treating
neurological disorders via mechanically stimulating the 8.sup.th
cranial nerve in a patient in need of such treatment. In some
embodiments, the neurological disorder to be treated is selected
from ADHD, autism, and Parkinson's.
Experimental
[0090] An experimental test procedure was set up to determine and
establish the effectiveness of the device to increase concentration
or increase relaxation. To determine effectiveness, a standard EEG
was used to measure various brain waves. The importance and
interpretation of these was determined consistent with what is
reported in the literature. Generally, increased alpha wave
activity when the test subject's eyes are closed indicates
increased relaxation. Increased Beta wave activity typically means
the brain is awake and thinking (in general) and it does not
necessarily mean excitation as might be interpreted from some
graphs. In the prefrontal and sometimes frontal lobes, where
interpretation and logic are performed, increased Beta wave
activity suggests increased concentration. These channels are
important to review when making assessments during math or reading
tasks. As used herein, the various brain waves are:
Scoring Frequencies
[0091] Beta: >12.0 Hz
[0092] Alpha: 8-12 Hz
[0093] Theta: 4-7.5 Hz
[0094] Delta: 0.5-3.5 Hz
[0095] Set-Up and Test Method:
[0096] Test subject was an adult female with no known disorders
related to ADD, ADHD, anxiety or any other condition. This clinical
profile was chosen since it would represent the most difficult
situation to improve upon with regard to increasing concentration
or attention, or to improve relaxation.
[0097] Test subject was instrumented with a traditional "10-20" EEG
lead placement on the scalp. Commercial neurophysiology software
was used to acquire EEG data in real time during studies conducted
during evening hours.
[0098] Studies were conducted to collect data across 19 leads with
a sample rate of 1000 Hz, filtering for 60 Hz noise rejection
(related to the common frequency used in the United States). Each
study was initiated after each lead was calibrated and verified by
the software to have minimal impedance (indicating a good
connection to the scalp for signal acquisition).
[0099] Test Protocol:
[0100] The test protocol mimicked study protocols used for qEEG to
study subjects with ADD, ADHD, Anxiety or other neurological
disorders. This included the following sequence:
[0101] 1. Sit relaxed with eyes open for up to several minutes
(allowing subject to blink naturally)
[0102] 2. Sit relaxed eyes closed for up to several minutes
[0103] 3. Sit relaxed with eyes open for several minutes (allowing
subject to blink naturally)
[0104] 4. Complete Math Task for several minutes. This included
counting backwards from a random number at an interval given at the
beginning of the study (for example, start at X and count backwards
by Y).
[0105] 5. Complete Read Task for several minutes. This included
reading several chapters of a book (the book presented was one that
test subject had not seen/read prior)
[0106] 6. Repeat the above protocol while wearing device with it
turned on. Similar tasks with new starting material were
undertaken. When the device is on, it has both vibration and an
auditory element. In this case, the auditory element was the
stimulation sound created by the vibration motor. The vibration
stimulation consisted of a pressure element applied to the back of
the ear. The vibration of the pressure sensor was generated using a
sign wave with an amplitude of 2V peak-to-peak and a frequency of
0.5 hertz. The amplitude of the pressure sensor can be changed to
ensure that the vibration is felt through the skin. The stimulus
was applied for the full duration of this study protocol.).
[0107] Device Parameters:
[0108] Round in shape--12 mm (0.5'') diameter, 3.4 mm (0.134'')
thick.
[0109] No visible moving parts.
[0110] Adhesive used on one side to fix to body
[0111] Placement: Behind ear, bilateral
[0112] Vibration Design:
[0113] 2V, changeable peak-to-peak voltage amplitude,
[0114] 0.5 Hz frequency (also changeable), bilateral
[0115] Waveform: Sine wave capable of up to 1G vibration at 12,000
rpm from 3V with current less than 80 mA.
[0116] Auditory Design
[0117] Audible Frequency range used, bilateral
[0118] Analysis:
[0119] All data were recorded and annotated to mark events (task
start, task stop, eye blinks, coughs, noticeable head movements,
etc). As is customary in the field, representative sections were
digitally analyzed and compared with and without using the device.
FFT (fast Fourier transform) was the method used by software to
present the spectral distribution. All results screens were
generated automatically by the software. The tables were created
using specific channel data reported by the software. No
custom/home developed software was used to review or analyze the
data.
Concentration
[0120] The subject was instrumented with the EEG electrodes and
paced through a series of math and reading tasks while not wearing
the device (control) and while wearing the device. The electrodes
on the prefrontal cortex (FP1 and FP2) are key channels indicating
concentration.
Math Task:
[0121] The table below shows a baseline reading of the test subject
performing a math task without the device. The EEG readout is shown
in FIG. 14, and generally indicates concentration during the math
task.
TABLE-US-00001 Math Task-No Device Predominance of the cerebral
rhythms by channel Theta/(sum Theta Beta 1 Beta 2 Beta 3 of Beta)
FP1 20.81% 10.84% 5.93% 5.79% 92.24% FP2 16.24% 11.47% 7.76% 6.23%
63.79% F7 19.60% 13.51% 8.06% 6.76% 69.18% F8 17.07% 16.11% 8.68%
7.54% 52.80% F3 18.76% 16.97% 10.62% 7.76% 53.07% F4 19.87% 19.58%
8.47% 8.12% 54.94% FZ 20.06% 14.78% 7.11% 8.20% 66.67% FP1 &
FP2 (Prefrontal cortex) are key channels indicating concentration
Control
[0122] By comparison, the table below shows the same subject
performing a similar math task while wearing the device. The
results generally show increased Beta activity, and a decreased
ratio of theta activity to beta activity. Each of these is
generally indicative of an increase in concentration. The EEG
readout is shown in FIG. 15 and supports the conclusion of
increased concentration.
TABLE-US-00002 Mask Task - Device On Predominance of the cerebral
rhythms by channel Theta/(sum Theta Beta 1 Beta 2 Beta 3 of Beta)
Results* FP1 16.28% 19.27% 18.28% 17.98% 29.32% Decreased
Theta/Beta FP2 19.33% 15.39% 15.11% 12.26% 45.21% Decreased
Theta/Beta F7 17.53% 16.21% 16.56% 14.07% 37.43% Decreased
Theta/Beta F8 22.74% 19.22% 15.82% 10.44% 50.00% Decreased
Theta/Beta F3 18.39% 18.71% 16.33% 12.25% 38.89% Decreased
Theta/Beta F4 23.03% 17.00% 14.80% 14.32% 49.93% Decreased
Theta/Beta FZ 22.02% 15.09% 17.92% 12.89% 47.97% Decreased
Theta/Beta FP1 & FP2 (Prefrontal Cortex) are key channels
indicating concentration *Desired result is Decreased Theta/Beta
indicating higher concentration
[0123] The data above, indicate that the test subject appears to
have a higher level of concentration while wearing the device.
Reading Task:
[0124] The table below shows a baseline reading of the test subject
performing a reading task without the device.
TABLE-US-00003 Reading Task-No Device Predominance of the cerebral
rhythms by channel Theta/(sum Theta Beta 1 Beta 2 Beta 3 of Beta)
FP1 22.06% 13.01% 6.61% 5.16% 89.02% FP2 22.44% 13.77% 6.46% 5.12%
88.52% F7 19.22% 15.72% 8.43% 7.23% 61.25% F3 22.06% 15.45% 9.76%
6.81% 68.89% F8 23.23% 15.76% 8.44% 5.50% 78.22% F4 21.28% 17.34%
10.25% 6.08% 63.20% FZ 23.93% 14.66% 8.59% 6.21% 81.23% FP1 &
FP2 (Prefrontal Cortex) are key channels indicating concentration
Control
[0125] By comparison, the table below shows the same subject
performing a similar reading task while wearing the device. The
results generally show increased Beta activity, and a decreased
ratio of theta activity to beta activity. Each of these is
generally indicative of an increase in concentration.
TABLE-US-00004 Reading Task - Device On Predominance of the
cerebral rhythms by channel Theta/(sum Theta Beta 1 Beta 2 Beta 3
of Beta) Results* FP1 20.17% 16.66% 8.74% 6.25% 63.73% Decreased
Theta/Beta FP2 18.77% 14.86% 7.93% 6.37% 64.37% Decreased
Theta/Beta F7 18.49% 16.87% 10.98% 7.23% 52.71% Decreased
Theta/Beta F3 13.73% 20.73% 11.94% 7.44% 34.23% Decreased
Theta/Beta F8 18.26% 20.25% 11.39% 9.53% 44.35% Decreased
Theta/Beta F4 21.50% 21.53% 14.42% 8.43% 48.45% Decreased
Theta/Beta FZ 21.18% 15.79% 10.30% 7.57% 62.92% Decreased
Theta/Beta FP1 & FP2 (Prefrontal Cortex) are key channels
indicating concentration *Desired result is Decreased Theta/Beta
indicating higher concentration
[0126] The data above, indicate that the test subject appears to
have a higher level of concentration while wearing the device.
Relaxation
[0127] The same test subject was used to test the device's effect
on relaxation. Here, the electrodes on the Occipital cortex (O1 and
O2) are key channels for indicating relaxation.
[0128] The table below and associated EEG readout (FIG. 16) show
the expected alpha predominance while relaxing.
TABLE-US-00005 Relaxation Task-No Device Predominance of the
cerebral rhythms by channel Alpha Beta 1 Beta 2 Beta 3 Sum Of Beta
O1 27.13% 19.55% 15.23% 10.21% 44.99% O2 30.27% 20.89% 10.06% 8.22%
39.17% T3 20.04% 24.66% 12.57% 10.69% 47.92% T5 28.85% 22.17% 9.81%
5.84% 37.82% P3 34.22% 21.20% 9.32% 5.12% 35.64% F8 20.17% 18.25%
9.81% 6.95% 35.01% T4 21.23% 23.02% 12.27% 11.04% 46.33% T6 30.51%
21.69% 8.47% 5.53% 35.69% F4 18.94% 19.69% 9.73% 6.52% 35.94% P4
37.82% 21.26% 7.90% 5.01% 34.17% PZ 34.55% 20.69% 8.08% 4.62%
33.39% O1 & O2 (Occipital cortex) are key channels for
indicating relaxation Control
[0129] The table below, and associated EEG readout (FIG. 17) show
generally increased alpha activity, and decreased overall Beta
activity when compared to the control, both indicative of enhanced
relaxation.
TABLE-US-00006 Relaxation Task - Device On Predominance of the
cerebral rhythms by channel Resulting Sum of Resulting total Alpha
Beta 1 Beta 2 Beta 3 Beta Alpha* Beta* O1 30.63% 21.76% 12.51%
7.56% 41.83% Increased Decreased Alpha Beta sum O2 40.66% 19.70%
9.15% 7.65% 36.50% Increased Decreased Alpha Beta sum T3 20.82%
23.49% 13.13% 11.66% 48.28% Increased Increased Alpha Beta sum T5
22.22% 25.83% 12.49% 6.69% 45.01% Decreased Increased Alpha Beta
sum P3 27.82% 25.48% 11.57% 6.73% 43.78% Decreased Increased Alpha
Beta sum F8 27.85% 13.39% 11.06% 9.72% 34.17% Increased Decreased
Alpha Beta sum T4 34.57% 18.78% 8.56% 7.64% 34.98% Increased
Decreased Alpha Beta sum T6 44.12% 18.24% 7.10% 5.89% 31.23%
Increased Decreased Alpha Beta sum F4 21.03% 17.44% 12.73% 8.64%
38.81% Increased Increased Alpha Beta sum P4 50.06% 20.05% 8.00%
4.57% 32.62% Increased Decreased Alpha Beta sum PZ 42.22% 19.64%
9.08% 4.93% 33.65% Increased Increased Alpha Beta sum O1 & O2
(Occipital Cortex) are key channels for indicating relaxation
*Desired result is Increased Alpha and Decreased Beta indicating a
more relaxed state.
[0130] Thus, the data show that the device can be used to increase
concentration if needed, as well as enhance relaxation when needed.
Depending upon a patient's condition, either may be useful in the
treatment or management of their condition or disorder.
[0131] For example, in patients with attention deficit disorder,
those with the hyperactivity component may benefit from the enhance
relaxation effect that can be triggered by the device. Those
without the hyperactivity component can benefit from increased
concentration. Either way, the device and methods of using it are
flexible enough to allow for treatment of both conditions, when
necessary.
[0132] The disclosure herein is meant to be illustrative in nature.
Those of skill in the art will recognize additional variants of the
invention which are within the scope and spirit of the invention
disclosed here.
* * * * *