U.S. patent application number 12/855258 was filed with the patent office on 2011-02-17 for methods for treating psychiatric disorders using light energy.
Invention is credited to Fredric Schiffer.
Application Number | 20110040356 12/855258 |
Document ID | / |
Family ID | 43586487 |
Filed Date | 2011-02-17 |
United States Patent
Application |
20110040356 |
Kind Code |
A1 |
Schiffer; Fredric |
February 17, 2011 |
Methods for Treating Psychiatric Disorders Using Light Energy
Abstract
Methods for treating psychiatric disorders using light energy
are disclosed herein. A method for treating psychiatric disorders
using light energy includes determining which hemisphere of the
brain requires treatment using lateral visual field stimulation
(LVFS) and applying light energy to the hemisphere of the brain to
treat the psychiatric disorder other than depression. In an
embodiment, light energy may include near infrared light (NIR). The
methods of the present disclosure may be used to treat a variety of
psychiatric disorders. In an embodiment, the methods may be used to
treat a psychiatric disorder co-morbid with depression.
Inventors: |
Schiffer; Fredric;
(Wellesley, MA) |
Correspondence
Address: |
GREENBERG TRAURIG, LLP
ONE INTERNATIONAL PLACE, 20th FL, ATTN: PATENT ADMINISTRATOR
BOSTON
MA
02110
US
|
Family ID: |
43586487 |
Appl. No.: |
12/855258 |
Filed: |
August 12, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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61233318 |
Aug 12, 2009 |
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Current U.S.
Class: |
607/88 |
Current CPC
Class: |
A61M 21/02 20130101;
A61N 2005/0651 20130101; A61N 5/0618 20130101; A61N 2005/0659
20130101 |
Class at
Publication: |
607/88 |
International
Class: |
A61N 5/06 20060101
A61N005/06 |
Claims
1. A method for treating a psychiatric disorder in a patient
comprising: measuring a left hemispheric emotional valence and a
right hemispheric emotional valence for a left hemisphere and a
right hemisphere of a brain using a lateral visual field
stimulation test; determining which hemisphere of the brain of the
patient requires treatment; and applying light energy to the
hemisphere of the brain to treat the psychiatric disorder other
than depression.
2. The method of claim 1, wherein the psychiatric disorder includes
one of attention deficit disorder, schizophrenia, bipolar disorder,
anxiety disorders, post-traumatic stress disorder, substance abuse
disorders, alcoholism, opiate dependence, eating disorders such as
anorexia and bulimia, phobias, Asperser's syndrome, dissociative
disorders, insomnia, borderline personality disorder, persistent
anxiety, anxiety attacks, feelings of panic, fears of social
contacts, nightmares, flashbacks, obsessive thoughts, compulsive
behavior, attention disorder, sexual problem, irrational thinking
or combinations thereof.
3. The method of claim 1, wherein the treatment causes a reduction
or elimination of the psychiatric disorder.
4. The method of claim 1, wherein the light energy is applied to
one of the hemisphere of the brain with a positive PANAS score, the
hemisphere of the brain with a negative PANAS score, both the
hemisphere of the brain with a positive PANAS score and the
hemisphere of the brain with a negative PANAS score, or
combinations thereof.
5. The method of claim 1, wherein the light energy is near infrared
light.
6. The method of claim 1, wherein the light energy has a wavelength
of about 810 nanometers.
7. The method of claim 1, wherein the light energy has a power
density about 250 mW/cm.sup.2.
8. The method of claim 1, wherein the light energy is applied at a
distance of about 4 mm from the skin.
9. The method of claim 1, further comprising delivering the light
energy for at least one treatment period of at least about four
minutes to a treated area.
10. The method of claim 1, further comprising pulsing the light
energy during a treatment period.
11. The method of claim 1, further comprising applying light energy
continuously during a treatment period.
12. A method for treating a psychiatric disorder in a patient:
measuring a left hemispheric emotional valence for a left
hemisphere of a brain and a right hemispheric emotional valence for
a right hemisphere of the brain using a lateral visual field
stimulation test; determining the hemisphere of the brain in need
of treatment; and applying light energy to the hemisphere of the
brain to treat the psychiatric disorder co-morbid with
depression.
13. The method of claim 12, wherein the psychiatric disorder
includes one of attention deficit disorder, schizophrenia, bipolar
disorder, anxiety disorders, post-traumatic stress disorder,
substance abuse disorders, alcoholism, opiate dependence, eating
disorders such as anorexia and bulimia, phobias, Asperser's
syndrome, dissociative disorders, insomnia, borderline personality
disorder, persistent anxiety, anxiety attacks, feelings of panic,
fears of social contacts, nightmares, flashbacks, obsessive
thoughts, compulsive behavior, attention disorder, sexual problem,
irrational thinking or combinations thereof.
14. The method of claim 12, wherein the treatment causes a
reduction or elimination of the psychiatric disorder.
15. The method of claim 12, wherein the light energy has a
wavelength of about 300 nanometers to a wavelength of about 1500
nanometers.
16. The method of claim 12, wherein the light energy has a power
density of up to about 320 mW/cm.sup.2.
17. A method for treating a patient comprising: determining which
portion of the brain needs treatment; and applying light energy to
the portion of the brain to treat the patient.
18. The method of claim 17, wherein the patient is being treated
for depression.
19. The method of claim 17, wherein the treatment causes an
improvement in the well-being of the patient.
20. A method for treating a psychiatric disorder in a patient
comprising applying light energy to a brain to treat the
psychiatric disorder.
21. The method of claim 20, wherein the psychiatric disorder
includes one of depression, attention deficit disorder,
schizophrenia, bipolar disorder, anxiety disorders, post-traumatic
stress disorder, substance abuse disorders, alcoholism, opiate
dependence, eating disorders such as anorexia and bulimia, phobias,
Asperser's syndrome, dissociative disorders, insomnia, borderline
personality disorder, persistent anxiety, anxiety attacks, feelings
of panic, fears of social contacts, nightmares, flashbacks,
obsessive thoughts, compulsive behavior, attention disorder, sexual
problem, irrational thinking or combinations thereof.
Description
RELATED APPLICATIONS
[0001] This application is related to and claims the benefit of
priority from U.S. Provisional Patent Application No. 61/233,318,
filed on Aug. 12, 2009, the entirety of which is incorporated
herein by reference.
FIELD
[0002] The embodiments disclosed herein relate to the treatment of
psychiatric disorders, and more particularly to the treatment of
psychiatric disorders using light energy.
BACKGROUND
[0003] The application of intense light, a non-ionizing
phototherapy, has been reported in over a thousand scientific
publications to have therapeutic efficacy for a wide range of
disorders in humans without any observed harmful effects. Light has
been demonstrated in cell culture to increase mitochondrial
respiration, increase ATP synthesis, increase heat shock proteins,
induce transforming growth factor .beta.-1, and increase nerve cell
proliferation and migration. Light has been tested in animals to
facilitating wound healing, promote the process of skeletal muscle
regeneration, and reduce infarct size in ischemic heart muscle by
50 to 70% in an induced experimental model in rats and dogs. Light
in the near infrared spectrum, which penetrates the scalp and
skull, can significantly reduce damage from experimentally induced
stroke in rats and rabbits, and to improve the memory performance
of middle aged mice, and reduce damage from acute stroke in humans.
A method of treating psychiatric disorders using light energy is
needed.
SUMMARY
[0004] Methods for treating psychiatric disorders using light
energy are disclosed herein.
[0005] According to aspects illustrated herein, there is provided a
method for treating psychiatric disorders using light energy,
including determining which hemisphere of the brain requires
treatment using lateral visual field stimulation (LVFS) and
applying light energy to the hemisphere of the brain to treat the
psychiatric disorder other than depression. In an embodiment, light
energy may include near infrared light (NIR). The methods of the
present disclosure may be used to treat a variety of psychiatric
disorders.
[0006] According to aspects illustrated herein, there is provided a
method for treating a psychiatric disorder in a patient, including
measuring a left hemispheric emotional valence and a right
hemispheric emotional valence for a left hemisphere of the brain
and a right hemisphere of the brain using a lateral visual field
stimulation test; determining which hemisphere of the brain needs
treatment; and applying light energy to the hemisphere of the brain
to treat the psychiatric disorder co-morbid with depression.
[0007] According to aspects illustrated herein, there is provided a
method for treating a psychiatric disorder in a patient, including
measuring a left hemispheric emotional valence for a left
hemisphere of the brain and a right hemispheric emotional valence
for a right hemisphere of the brain using a lateral visual field
stimulation test; determining the hemisphere of the brain in need
of treatment; and applying light energy to the hemisphere of the
brain to treat the psychiatric disorder co-morbid with
depression.
[0008] According to aspects illustrated herein, there is provided a
method for treating psychiatric disorders using light energy,
including determining which hemisphere of the brain has a more
positive psychology or valence, using lateral visual field
stimulation (LVFS), and applying light energy to the hemisphere
with the more positive valence. In an embodiment, light energy may
include near infrared light (NIR). The methods of the present
disclosure may be used to treat a variety of psychiatric
disorders.
[0009] According to aspects illustrated herein, there is provided a
method for treating psychiatric disorders using light energy,
including determining which hemisphere of the brain has a more
negative psychology or valence, using lateral visual field
stimulation (LVFS), and applying light energy to the hemisphere
with the more negative valence to improve its functioning. In an
embodiment, light energy may include near infrared light (NIR). The
methods of the present disclosure may be used to treat a variety of
psychiatric disorders.
[0010] According to aspects illustrated herein, there is provided a
method for treating psychiatric disorders using light energy,
including determining which hemisphere of the brain has a more
positive and negative psychology or valence, using lateral visual
field stimulation (LVFS); applying light energy to the hemisphere
with the more positive affect; and applying light energy to the
hemisphere with the more negative effect. In an embodiment, if both
hemispheres have about equal levels of positive or negative
valence, both hemispheres may benefit from the light energy. In an
embodiment, light energy may include near infrared light (NIR). The
methods of the present disclosure may be used to treat a variety of
psychiatric disorders.
[0011] According to aspects illustrated herein, there is provided a
method for treating psychiatric disorders using light energy,
including determining which hemisphere of the brain has a more
negative psychology or valence, using lateral visual field
stimulation (LVFS); applying light energy to the hemisphere with
the more negative affect; and increasing cerebral blood flow in the
opposing hemisphere. In an embodiment, light energy may include
near infrared light (NIR). The methods of the present disclosure
may be used to treat a variety of psychiatric disorders.
[0012] According to aspects illustrated herein, there is provided
method for treating a patient, including determining which portion
of the brain of the patient requires treatment; and applying light
energy to the portion to treat the patient. The light might be
applied bilaterally over the left and the right dorsolateral
pre-frontal corticies. In an embodiment, the treatment may be used
to treat depression. In another embodiment, the treatment may be
used to improve the well-being of the patient.
[0013] According to aspects illustrated herein, there is provided a
method for treating a patient, including determining which portion
of the brain needs treatment; and applying light energy to the
portion of the brain to treat the patient. In an embodiment, the
treatment may be used to treat depression. In an embodiment, the
treatment may be used to cause an improvement in the well-being of
the patient.
[0014] According to aspects illustrated herein, there is provided a
method for treating a psychiatric disorder in a patient including
applying light energy to a brain to treat the psychiatric
disorder.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The presently disclosed embodiments will be further
explained with reference to the attached drawings, wherein like
structures are referred to by like numerals throughout the several
views. The drawings shown are not necessarily to scale, with
emphasis instead generally being placed upon illustrating the
principles of the presently disclosed embodiments.
[0016] FIG. 1 shows a front view of glasses used for lateral visual
field stimulation.
[0017] FIGS. 2A-2B show images of the brain having different
activity by functional magnetic resonance imaging (fMRI) in the
left and right cerebral hemispheres after looking out of the left
or the right lateral visual field. FIG. 2A shows brain activity
after looking out of the left half of the left eye (the left
lateral visual field). FIG. 2B shows brain activity after looking
out of the right half of the right eye (the right lateral visual
field).
[0018] FIG. 3 shows NIR light being applied to the left side of the
head using Photobiomodulation (PBM). The patches above the
patient's eyebrows are connected to a commercial device for
measuring cerebral blood flow in the front of the brain on the left
and the right sides.
[0019] FIG. 4 shows a close up of the NIR-PBM device of FIG. 3.
[0020] FIG. 5 shows a control unit of the NIR-PBM device of FIG.
3.
[0021] FIG. 6 shows that there was an increase in cerebral blood
flow when the NIR light was on compared to when it was off
[0022] FIG. 7 shows that after the NIR treatment, there was an
increase in positive affect when the brain hemisphere with a
positive emotional valence was treated (matched treatment and
hemisphere), but a decrease in positive affect when the brain
hemisphere with a negative emotional valence was treated
(unmatched).
[0023] FIG. 8 shows that at 2-weeks post treatment, a decrease in
anxiety (as measured by the Hamilton Anxiety Rating Scale) was
related to the patient's baseline hemispheric emotional valence
(HEV) and cerebral blood flow. Those patients with a left negative
HEV and an increase in right frontal CBF had less anxiety, as did
those patients with a right negative HEV and an increase in left
frontal CBF.
[0024] While the above-identified drawings set forth presently
disclosed embodiments, other embodiments are also contemplated, as
noted in the discussion. This disclosure presents illustrative
embodiments by way of representation and not limitation. Numerous
other modifications and embodiments can be devised by those skilled
in the art which fall within the scope and spirit of the principles
of the presently disclosed embodiments.
DETAILED DESCRIPTION
[0025] Methods of treating psychiatric or psychological disorders
using light energy are disclosed herein. The methods of the present
disclosure may include using lateral visual field stimulation
(LVFS) to determine which hemisphere of the brain requires
treatment. Light energy may be applied to the chosen hemisphere to
treat the psychological disorder. In an embodiment, the light
energy may include near infrared light (NIR). The methods of the
present disclosure may be used to treat a variety of psychological
disorders.
[0026] As used herein, the terms "depression," "depressive
disorder," "dysthymic disorder," "major depressive disorder" and
"unipolar depression" refer to a DSM-IV definition of
depression.
[0027] As used herein, the term "psychiatric disorders" refers to
any psychiatric disorders including, but not limited to,
depression, attention deficit disorder, schizophrenia, bipolar
disorder, anxiety disorders, alcoholism, eating disorders such as
anorexia and bulimia, phobias, Asperser's syndrome, dissociative
disorders, insomnia, and borderline personality disorder. The
DSM-IV definition applies to these psychiatric disorders.
Psychiatric disorders also include substance abuse disorders (i.e.,
alcohol abuse or opiate dependence or abuse) caused either by
depression or not caused by depression, persistent anxiety, anxiety
attacks, feelings of panic, fears of social contacts, nightmares,
flashbacks, obsessive thoughts, compulsive behavior, attention
disorder, sexual problem, and irrational thinking.
[0028] As used herein, the term "co-morbid" or "co-existent" refers
to any psychiatric disorders that exist in addition to a primary
disease or disorder, such as depression.
[0029] As used herein, the term "transcranial" refers to a
procedure that is performed through the cranium, or the skull that
covers and protects the brain. Transcranial refers to a noninvasive
method that delivers energy to the neurons of the brain.
Transcranial therapy can cause activity in specific or general
parts of the brain with minimal discomfort, allowing the
functioning and interconnections of the brain to be studied and/or
treated. The light device is held on the scalp, no actual contact
is necessary, and the energy passes through the skull and into the
brain. Small induced currents can then make brain areas below the
light device more or less active, depending on the settings
used.
[0030] As used herein, the term "treat", "treating" or
"stimulating" refers to enhancing a person's positive outlook or
suppressing a person's negative outlook. This may refer to a
person's psychological well-being, including but not limited to
their emotional, cognitive, and motivational states. Those persons
who are successfully treated can find more appreciation for life,
for themselves (improved self-esteem), their work, and their
personal relationships.
[0031] Well-being refers to a state of wellness of body, mind and
soul, where all are in a state of health, the individual is happy
and prospering. Well-being describes the overall welfare of an
individual including a good or satisfactory condition of existence.
Well-being is a state characterized by health, happiness, and
prosperity.
[0032] Psychiatric disorders include, but are not limited to,
depression, attention deficit disorder, schizophrenia, bipolar
disorder, anxiety disorders, alcoholism, eating disorders such as
anorexia and bulimia, phobias, Asperser's syndrome, dissociative
disorders, insomnia and borderline personality disorder. One
prevalent psychiatric disorder is depression. Depression may be
defined as a combination of sadness, loss of energy, feelings of
hopelessness, difficulty concentrating, insomnia, and irritability.
The National Comorbidity Survey reported that 46% of men and 58% of
women have suffered in their lifetime at least a two-week period in
which they experienced a persistent depressed mood. Major
depression has a lifetime prevalence of about 16%, and it is
estimated that by 2020, it will be the second greatest contributor
to the impairment of global health. A recent Australian survey
reported that anxiety disorders were the most common mental
disorder with a lifetime prevalence of 26%.
[0033] In psychiatry, the Diagnostic and Statistical Manual of
Mental Disorders, 4th Edition (DSM-IV) is a manual published by the
American Psychiatric Association (APA) that includes all currently
recognized mental health disorders. In the DSM-IV, there are two
diagnoses for depression, Major Depression and Dysthymic Disorder,
as described below.
[0034] Major Depressive Disorder is characterized by one or more
Major Depressive Episodes (i.e., at least 2 weeks of depressed mood
or loss of interest accompanied by at least four additional
symptoms of depression). Dysthymic Disorder is characterized by at
least 2 years of depressed mood for more days than not, accompanied
by additional depressive symptoms that do not meet criteria for a
Major Depressive Episode.
[0035] Criteria for Major Depressive Episode include:
[0036] A. Five (or more) of the following symptoms have been
present during the same 2-week period and represent a change from
previous functioning; at least one of the symptoms is either (1)
depressed mood or (2) loss of interest or pleasure. Note: Do not
include symptoms that are clearly due to a general medical
condition, or mood-incongruent delusions or hallucinations. [0037]
(1) depressed mood most of the day, nearly every day, as indicated
by either subjective report (e.g., feels sad or empty) or
observation made by others (e.g., appears tearful). Note: In
children and adolescents, can be irritable mood. [0038] (2)
markedly diminished interest or pleasure in all, or almost all,
activities most of the day, nearly every day (as indicated by
either subjective account or observation made by others) [0039] (3)
significant weight loss when not dieting or weight gain (e.g., a
change of more than 5% of body weight in a month), or decrease or
increase in appetite nearly every day. Note: In children, consider
failure to make expected weight gains. [0040] (4) insomnia or
hypersomnia nearly every day [0041] (5) psychomotor agitation or
retardation nearly every day (observable by others, not merely
subjective feelings of restlessness or being slowed down) [0042]
(6) fatigue or loss of energy nearly every day [0043] (7) feelings
of worthlessness or excessive or inappropriate guilt (which may be
delusional) nearly every day (not merely self-reproach or guilt
about being sick) [0044] (8) diminished ability to think or
concentrate, or indecisiveness, nearly every day (either by
subjective account or as observed by others) [0045] (9) recurrent
thoughts of death (not just fear of dying), recurrent suicidal
ideation without a specific plan, or a suicide attempt or a
specific plan for committing suicide
[0046] B. The symptoms do not meet criteria for a Mixed
Episode.
[0047] C. The symptoms cause clinically significant distress or
impairment in social, occupational, or other important areas of
functioning.
[0048] D. The symptoms are not due to the direct physiological
effects of a substance (e.g., a drug of abuse, a medication) or a
general medical condition (e.g., hypothyroidism).
[0049] E. The symptoms are not better accounted for by Bereavement,
i.e., after the loss of a loved one, the symptoms persist for
longer than 2 months or are characterized by marked functional
impairment, morbid preoccupation with worthlessness, suicidal
ideation, psychotic symptoms, or psychomotor retardation.
[0050] Diagnostic criteria for Dysthymic Disorder include:
[0051] A. Depressed mood for most of the day, for more days than
not, as indicated either by subjective account or observation by
others, for at least 2 years. Note: In children and adolescents,
mood can be irritable and duration must be at least 1 year.
[0052] B. Presence, while depressed, of two (or more) of the
following: [0053] (1) poor appetite or overeating [0054] (2)
insomnia or hypersomnia [0055] (3) low energy or fatigue [0056] (4)
low self-esteem [0057] (5) poor concentration or difficulty making
decisions [0058] (6) feelings of hopelessness
[0059] The DSM-IV (1), the International Classification of Diseases
(ICD-9-CM)(2), and as described in The Comprehensive Textbook of
Psychiatry (3), thus, define depressive disorders, which in the
DSM-IV and the ICD-9-CM are given specific diagnostic codes: major
depression is 962.3 and dysthymia is 300.4. In distinction from the
depressive disorders, the DSM-IV, ICD-9-CM, the Comprehensive
Textbook of Psychiatry, and the accepted practice in the profession
(4) consider other disorders as separated and distinct psychiatric
diagnoses. The DSM-IV list of major categories is as follows:
[0060] Disorders Usually First Diagnosed in Infancy, Childhood, or
Adolescence [0061] Delirium, Dementia, and Amnestic and Other
Cognitive Disorders [0062] Mental Disorders Due to a General
Medical Condition [0063] Substance-Related Disorders [0064]
Schizophrenia and Other Psychotic Disorders [0065] Mood Disorders
[0066] Anxiety Disorders [0067] Somatoform Disorders [0068]
Factitious Disorders [0069] Dissociative Disorders [0070] Sexual
and Gender Identity Disorders [0071] Eating Disorders [0072] Sleep
Disorders [0073] Impulse-Control Disorders Not Elsewhere Classified
[0074] Adjustment Disorders [0075] Personality Disorders [0076]
Other Conditions That May Be a Focus of Clinical Attention
[0077] The depressive disorders are listed under Mood Disorders.
The profession considers other diagnostic categories distinct and
separate from depressive disorders in terms of diagnosis,
treatment, clinical course, symptoms, genetics, and brain
pathophysiology. For example, electro-convulsive therapy is
commonly used to treat major depression, but is not used for
childhood disorders, dementia, mental disorders due to a general
medical condition, substance-related disorders, anxiety disorders,
somatoform disorders, factitious disorders, dissociative disorders,
sexual and gender identity disorders, eating disorders, sleep
disorders, impulse-control disorders, adjustment disorders or
personality disorders. Benzodiazepams such as diazepam or
klonazepam are common treatments for anxiety disorders but are
likely to make depressed patients more depressed. Schizophrenia is
treated with antipsychotic medications that, with a few exceptions,
are only used to treat psychotic patients. Buprenorphine is used to
treat opiate dependence, but is not approved for any other
diagnosis. Disulfiram is used only in the treatment of alcohol
dependence.
[0078] Depression can run in families, and usually starts between
the ages of 15 and 30. It is much more common in women. Women can
also get postpartum depression after the birth of a baby. Some
people get seasonal affective disorder in the winter. Depression is
one part of bipolar disorder. There are effective treatments for
depression, including antidepressants and talk therapy. Many
depressed people do best by using both.
[0079] Depression is considered separate and distinct from other
psychiatric or psychological disorders. Depression by any
definition does not encompass most psychological disorders. For
example, people who are diagnosed with schizophrenia have delusions
and/or hallucinations, and have a deterioration of their
personality rendering them almost always incapable of complex work
or sustained relationships. A person with an anxiety disorder will
suffer excessive apprehension and worry with heightened arousal,
but will not feel sad or hopeless unless he suffers, in addition, a
coexisting depressive disorder. A person who abuses substances will
usually not also suffer anxiety or depression, although he may have
a dual diagnosis in which both a substance abuse disorder and
another disorder such as an anxiety disorder or a depressive
disorder are also present. 47% of patients diagnosed with
schizophrenia also have a substance abuse disorder.
[0080] Each of the diagnostic entities in the DSM-IV are supported
not only by clinical descriptions, but also by biological studies
that use electroencephalography (EEG), magnetoencephalograpy (MEG),
functional magnetic resonance imaging (fMRI), evoked potentials,
electrodermal activity, biochemical markers (catecholamines and
catecholamine metabolites; indoleamines and indoleamine
metabolites, acetylcholine, histamine, aminoacids, melatonin,
prostaglaindins, opoid petptides, neupropeptides, enzymes, receptor
densities), psychoimmunological markers, genetic markers, and
animal models.
[0081] By modern scientific techniques, depressive disorders and
other DSM-IV disorders can be distinguished from each other. For
example, as reviewed in the textbook, Current Diagnosis and
Treatment: Psychiatry by Loosen and Shelon, antidepressant
treatments (including pharmacotherapy and electroconvulsive therapy
[ECT]) cause desensitization of the norepinephrine
receptor--coupled adenylate cyclase system in brain, which is
linked to a decrease in the density of adrenoceptors in the brain.
This decrease in receptor sites paralleled the delayed onset of
action common to all antidepressants. Further, depression is
associated with the integration of multiple intracellular signals
that regulate neuronal response (i.e., changes in G protein, cyclic
adenosine monophosphate, or protein kinase and the induction of
gene transcription). These intracellular signals ultimately affect
the expression of specific genes. It is these abnormalities of
intracellular signal transduction and/or gene expression that
underlie much of the physiology of depression. Other
neurotransmitters (e.g., acetylcholine, gamma amino butyric acid,
melatonin, glycine, histamine), hormones (e.g., thyroid and adrenal
hormones), and neuropeptides (e.g., corticotropin-releasing
hormone, endorphins, enkephalins, vasopressin, cholecystokinin,
substance P) also play significant roles in the physiology of
depression.
[0082] In depression, functional imaging studies most consistently
demonstrate a decreased prefrontal cortex (PFC), especially left
PFC, blood flow. These findings correlate with severity of illness
and cognitive impairment. Functional imaging in depressed patients
also show basal ganglia abnormalities, involving decreased blood
flow and metabolism as well as increased activity of amygdala. In
major depression, other neuroimaging studies show abnormalities in
the hippocampus, cingulate, and related parts of the striatum and
thalamus. Together data offer a neural model for depression in
which dysfunction of limbic, striatal, and PFC structures impair
the modulation of the amygdala/hippocampus complex and lead to
abnormal processing of emotional stimuli. Depression also tends to
be associated with lesions in the left frontotemporal or right
parieto-occipital regions.
[0083] Many patients with dysthymic disorder have brain wave (EEG)
abnormalities that mimic those found in major depression such as
reduced REM latency, increased REM density, reduced slow-wave
sleep, impaired sleep continuity. Patients with dysthymia who have
these EEG abnormalities more frequently have a positive family
history for major depression. They also respond better to
antidepressant medications.
[0084] Anxiety disorders have scientific findings that
differentiate them from depression and other psychiatric or
psychological disorders. In patients with anxiety disorders
functional neuroimaging shows abnormalities during symptom
provocation tests, in the limbic, paralimbic and sensory
association regions.
[0085] For anxiety there is a general theory of a neural
behavioral-inhibition system. This system evaluates stimuli to
attempt to determine their level of dangerousness and
simultaneously in response produce behavioral inhibition and
increase arousal and attention. Antianxiety drugs inhibit brain
areas involved in these responses. From animal studies using
pharmacological agents and/or brain lesions, anxiety is associated
with several interconnected anatomical areas. Sensory stimuli that
are interpreted as dangerous activate the hippocampus, especially
the entorhinal cortex, which secondarily induces habituation by
actions on the lateral and medial septal areas, which then
stimulate the cingulate which induces behavioral inhibition.
Several specific neurotransmitter systems influence this anxiety
mechanism, including noradrenergic activity of the locus coeruleus,
serotonergic systems originating in the raphe, and by widespread
GABAA-receptor activity (which are the main locus of activity of
the benzodiazepines).
[0086] Stimuli that are interpreted as acute threats activate the
"fight or flight" response, which is mediated especially by the
locus coeruleus and the amygdala. The amygdala encodes fearful
memories and aversive conditioning and participates in the acute
fear and negative anticipation that we call anxiety.
[0087] Further, intense anxiety stimulates the sympathetic nervous
system via the locus coeruleus, and this induces tachycardia,
tremor, and diaphoresis. The frontal cortex becomes aware of the
anxiety and induces behavioral responses which are attempts to
improve survival, but which often cause more harm and increase
danger. The cingulate, in anxiety disorders, attempts to improve
the communication between the cortex and the subcortical areas.
[0088] Patients with a panic disorder can have a panic attack
induced by intravenous sodium lactate or inhalation of 5-35% CO2.
This will not affect individuals who do not suffer a panic
disorder. These agents activate the locus coeruleus. There is new
evidence that 5-HT1A-receptor binding is reduced in some patients
with panic disorder.
[0089] In an embodiment, the methods of the present disclosure can
be used to diagnose and treat the human brain for psychological,
psychiatric, depressive, neurological, general well-being and other
conditions. In an embodiment, the methods of the present disclosure
may include the use of a light treatment device to diagnose and
treat depression. In an embodiment, the methods of the present
disclosure may be used to diagnose and treat psychiatric disorders
other than depression including, but not limited to, attention
deficit disorder, schizophrenia, bipolar disorder, anxiety
disorders, substance abuse disorders such as alcohol abuse and drug
abuse, eating disorders such as anorexia and bulimia, phobias,
Asperser's syndrome, dissociative disorders, insomnia, borderline
personality disorder or combinations thereof. In an embodiment, the
methods of the present disclosure may be used to diagnose and treat
other psychiatric or psychological disorders including, but not
limited to, persistent anxiety, anxiety attacks, feelings of panic,
fears of social contacts, nightmares, flashbacks, alcohol or drug
abuse, obsessive thoughts, compulsive behavior, attention disorder,
sexual problem, eating disorder such as anorexia, bulimia or
obesity, irrational thinking, or combinations thereof. In an
embodiment, the methods of the present disclosure may be used to
diagnose and treat psychiatric disorders that are co-morbid or
co-existent with depression. In an embodiment, the methods of the
present disclosure may be used to diagnose and treat more than one
psychiatric disorder at a given time. For instance, the method may
diagnose and treat a patient having both depression and attention
deficit disorder or a patient having both anorexia and insomnia. In
an embodiment, the methods of the present disclosure may be used to
benefit persons who do not have any psychological disorders. For
patients without any of the above psychological disorders, the
methods of the present disclosure may help improve their
psychological well-being and enhance their positive outlook. These
patients can find more appreciation for life, for themselves
(improved self-esteem), their work, and their personal
relationships. The methods of the present disclosure may improve
patient self-confidence, positive disposition, interpersonal
relationships, and/or quality of life.
[0090] A recently published study was conducted of an open clinical
trial of the use of transcranial near infra-red light to treat 10
psychiatric patients (5 males) with a current major depressive
disorder with a comorbid anxiety disorder, including 3 with a
history of Post-Traumatic Stress Disorder. Schiffer F, Johnston A
L, Ravichandran C, Polcari A, Teicher MH, Webb R H, Hamblin M R.
Psychological benefits 2 and 4 weeks after a single treatment with
near infrared light to the forehead: a pilot study of 10 patients
with major depression and anxiety. Behavioral and Brain Functions.
2009 Dec. 8; 5:46.
[0091] Seven of these patients had a past history of opiate
dependence (6 patients) and one had a history of alcohol
dependence. The patients were allowed to continue their usual
psychiatric treatments, but were asked, if possible to not alter
their on-going treatments. None altered their treatments from 2
weeks before the NIR-PBM or during the 4-week follow-up.
[0092] As a baseline measure each patient had a Standardized
Clinical Diagnostic Interview to determine their diagnosis. The
patients also had their hemispheric emotional valence measured
using lateral visual field stimulation (LVFS), which includes
having a patient look out of one side of taped safety goggles to
allow their vision to be restricted on either the left or the right
lateral visual field. Earlier studies found that LVFS can induce
EEG, ear temperature, and fMRI changes. These results indicate that
looking out the right visual field activates the left hemisphere of
the brain and that looking out of the left visual field activates
the right hemisphere of the brain.
[0093] Earlier studies further reported that looking out of one
lateral visual field for a minute or more can induce a personality
alteration such that one side (left or right) in 80% of patients
will induce a more mature personality while looking out of the
other visual field will stimulate a personality that is more
immature and more negatively effected by past traumas. By measuring
the affective state of the patient while he or she looks out of
both visual fields we can calculate a hemispheric emotional valence
which indicates the degree to which either the left or the right
cerebral hemisphere is mature and healthy or immature and neurotic.
Some studies suggest that using the patient's hemispheric valence
might guide the application of lateralized treatments to the brain
for psychiatric conditions as well as help in the evaluation of
data from experiments treating one cerebral hemisphere. For
example, two similar but different studies reported that the
baseline hemispheric emotional valence predicted which patients
would respond to left-sided transcranial magnetic stimulation, an
FDA approved treatment for depression that applies a powerful
electromagnet to the left-side of the head. Both studies suggested
that treating a patient who has a positive hemispheric valence in
his left hemisphere (the treated hemisphere) will do well, but that
patients who have a negative hemispheric emotional valence in their
left hemisphere (the treated hemisphere) will not do well.
[0094] As another baseline measure each patient was given a
Hamilton Depression Rating Scale, a Hamilton Anxiety Rating Scale,
and a Positive and Negative Affect Scale. The two Hamilton scales
are used to measure changes in depression and in anxiety from a
treatment over at least a week. The Positive and Negative Affect
Scale is used to measure immediate changes in mood following a
treatment.
[0095] Each patient's cerebral blood flow in the frontal poles of
their brain on both the left and right sides was measured using,
for instance, a commercial device. The patients then received 4
treatments. Two treatments were placebo treatments, with the near
infrared light turned off, one treatment was over the left side of
the forehead and another treatment was over the right-side. The two
active treatments consisted of a 4-minute treatment with near
infrared light at 240 mW, one on the left-side of the forehead and
the other on the right-side. Patients were unable to detect whether
the light was on or off, and so the light off condition acted as a
placebo condition.
[0096] Immediately after each treatment (left-side "on", left-side
"off", right-side "on", right-side "off" we measured the patient's
affective state with the Positive and Negative Affective Scale.
During each treatment we measured the cerebral blood flow in the
left and in the right frontal pole of the patient's brain. At two
weeks post treatment and at four weeks post-treatment we repeated
both of the Hamilton scales.
[0097] The study revealed several findings. First, following each
of the 4 treatment conditions, the Positive and Negative Affective
Scale scores showed an improvement if the side with a positive
hemispheric emotional valence was treated but a worsening in the
measured affective state if the hemisphere with a negative
hemispheric emotional valence were treated. Second, the study found
when the left side of the forehead was treated with the light on,
the frontal pole blood flow was 0.65.+-.sd 0.08, compared to
0.06.+-.sd 0.05 when the left-side was treated with the light off,
placebo condition.
[0098] The study also revealed that at 2-weeks post treatment (all
4 treatment conditions were given on the same day) there was a
dramatic improvement in both the Hamilton Depression Rating Scale
and in the Hamilton Anxiety Rating Scale. Sixty percent of the 10
patients went into a remission defined as a Hamilton Depression
Rating Scale score of .ltoreq.10 at 2-weeks post treatment. For the
Hamilton Anxiety Rating Scale, 70% achieved a remission at this
criteria. These results compare favorably other treatments for
depression or anxiety disorders such as cognitive behavior therapy
of 30 weeks, serotonin reuptake inhibitors for 8 weeks, a course of
transcranial magnetic stimulation or a course of electro-convulsive
shock therapy as discussed in our publication. Since the sample of
patients included those suffering from major depression, a
generalized anxiety disorder, post-traumatic stress disorder, and
recent substance abuse, this NIR-PBM treatment might be suitable
for additional diagnostic groups.
[0099] The study further showed that the outcomes on the Hamilton
Anxiety Rating Scale were predicted by an interaction between the
individual patient's hemispheric emotional valence times the
increase in blood flow in the frontal pole on the side of the
positive hemispheric valence. (See FIG. 8)
[0100] As a result, the study found that bilateral NIR-PBM
treatments led to highly significant improvements 2 weeks post
treatment. The study also found that immediately after treatment,
patients did well when the hemisphere with a positive valence was
treated and poorly when the hemisphere with a negative valence was
treated. From this observation, it is likely that treating only the
side with a positive hemispheric valence might give better results
than the bilateral treatment results at 2-weeks post treatment. The
location of treatment is likely also important. Treating over the
upper side of the forehead, in an embodiment, is likely to activate
the hemisphere while treating over the area of the forehead over
the eye may have an inhibitory effect.
[0101] The study results are not likely due to placebo effects for
several reasons. First, placebo effects are usually on the order of
a 20% improvement and our improvement was on the order of 50 to
60%. Second, cerebral blood flow increased when the NIR-PBM was
"on" versus the placebo "off" condition. Patients could not
determine whether or not the light was on or off. Third,
immediately following the treatments, the patients improved to a
greater extent when the hemisphere with a positive hemispheric
emotional valence was treated. And finally, the Hamilton Anxiety
Rating Scale scores were predicted by the product of the
lateralized cerebral blood flow and the hemispheric emotional
valence.
[0102] The methods of the present disclosure can be used with light
treatment devices known in the art that deliver light energy for
diagnosis and treatment of the human brain for psychological,
psychiatric, depressive, neurological, general well-being and other
conditions. In one embodiment, the methods of the present
disclosure may include the use of lateral visual field stimulation
(LVFS) in conjunction with light treatments to help treat a variety
of psychiatric disorders or psychological conditions. The brain is
at its core an information processor. It takes sensory inputs,
interprets them, and decides on a response. A computer is also an
information processor that takes inputs and creates responses or
outputs. The computer uses transistor states to code information;
the brain uses neural firing patterns or biological neural networks
to code its information. Like a computer the brain uses parallel
and serial processing, and different biological neural networks in
the brain operated somewhat independently, but, like a computer in
a network, are related to other biological neural networks. The
brain's neural networks have hierarchical arrangements. For
example, sensory association areas of the brain have biological
neural networks that process information from several primary
sensory areas (perhaps for hearing, sight, and touch). The
biological neural networks in the sensory association areas will
relate to higher order association areas in the frontal cortices
whose biological neural networks integrate the sensory information
with information from other biological neural networks having to do
with other functions such as emotion or memory. Each neural network
processes information, and as such is a mini-brain, which combines
with other biological neural networks to create higher levels of
function and eventually create a mind with perceptions, emotions,
motivations, and actions or behaviors. A person can have a dominant
high-level set of biological neural networks that support his
dominant personality, but he may have competing high-level sets of
neural networks that support a personality with somewhat different
perceptions, emotions, motivations, actions or behaviors. These
high level biological neural networks appear to have a relationship
with one or the other of the two cerebral hemispheres of the brain.
The neural networks associated with one hemisphere (either the left
or the right) might be more affected by past traumas and have a
more neurotic perception of the world. For example, someone who was
bullied as a child, might as an adult, have high level neural
networks that incorrectly perceive the world as hostile and
threatening. That person may have another set of high level neural
networks, associated with the other cerebral hemisphere, that are
healthier and see the world (as it now actually is) as safe.
Depending on which set of high-level neural networks is dominant at
a particular time, the person will manifest a personality that is
either troubled or is healthier (or some combination of the
two).
[0103] Childhood traumas are almost always associated with
biological neural networks that are associated with one hemisphere
more than the other. Troubled biological neural networks may not be
associated with only one hemisphere, but rather they may be
associated more with one hemisphere over the other and once
stimulated can take over the entire brain. Different set of neural
networks can compete for dominance and when in control can use more
and more of the brains neurons. In a computer, one program such as
Word uses the same transistors that a different program such as
Excel uses. The allocation of neurons within the brain may be
determined by the struggles between competing sets of biological
neural networks.
[0104] Each diagnostic entity is manifested by different
configurations of biological neural networks involving different
brain locations and different neural transmitters and so are
distinct entities as described above. However, each entity may
involve a healthier and a more pathological set of neural networks
that are associated each with one of the two cerebral hemispheres.
Which hemisphere is associated with the more pathological neural
networks has to be determined for each individual patient. This may
refer to a hemispheric valence. The hemisphere with the healthier
neural networks is said to have a more positive hemispheric
emotional valence. The other cerebral hemisphere is thought to have
a more negative hemispheric emotional valence.
[0105] This explanation is based mainly on two observations. The
first is that we know that the eyes in all people are connected to
the brain so that images projected to the left visual field are
sent first to the right cerebral hemisphere. The information can
then be sent via the corpus callosum to the opposite hemisphere,
but in patients in whom the corpus callosum has been severed as a
treatment for epilepsy, the image is seen only by one hemisphere.
This discovery led to the "Split-brain Studies" for which Roger
Sperry won the Nobel Prize. We found that having patients limit
their vision to either the left or right lateral visual field while
in an fMRI scanner led to the observation illustrated in FIG. 2
that when the patients looked out of their right lateral visual
field the blood flow (and presumably their brain activity) in their
left brain was dramatically increased. The opposite occurred when
the subjects looked out of the left lateral visual field.
[0106] In an embodiment, based on earlier publications, having a
person look out of one lateral visual field and then the other
could cause dramatic changes in the patients' psychological state.
About 60% of patients may feel differently when they look out of
one visual field versus the other and about 30% have extreme
responses. About 85% of patients with severe symptoms will have an
extreme response. An example of an extreme response is the
following: a patient who is a veteran of the war in Viet Nam looked
out of his right lateral visual field and saw a large plant behind
me and became alarmed. He said, "That plant looks like the jungle!"
I asked him quickly to look out of the left lateral visual field
and he said, "That's a nice looking plant." He was obviously
distressed when looking out the right lateral visual field and was
relaxed and calmed when looking out of the left lateral visual
field. The side in which the patient gets upset is consistent for
that patient, but for another given patient the side that is
upsetting can be either the left or right side. Patients with
post-traumatic stress disorder, about 65% of the time, feel more
distressed when they look out of the right visual field (left brain
is more distressed). Patients with major depression about 65% of
the time feel more distressed when looking out of the left lateral
visual field.
[0107] LVFS can be used to guide the placement of light treatments.
In an embodiment, LVFS may be used to activate positive neural
networks and negative neural networks. The positive neural networks
and the negative neural networks in the brain may be associated
with positive or negative outlooks on the world, respectively. In
an embodiment, traumatic experiences may be associated with
specific neural networks that are in some way associated with one
hemisphere. Treatment of psychological conditions may include
treating these negative neural networks, either through education,
suppression, by enhancing the positive neural networks associated
with the hemisphere with a positive HEV, psychotherapy, deep brain
stimulation, certain psychotropic medications, unilateral ECT,
transcranial magnetic stimulation (TMS) or by a combination of
methods. In an embodiment, near infrared (NIR) treatments may be
used to enhance the positive hemisphere, suppress the negative, and
to support the teaching or healing of the negative neural networks
so that the trauma can be tolerated, grieved and recovered from. In
another embodiment, NIR treatments can be combined with other
treatments.
[0108] In an embodiment, the methods of the present disclosure may
include the use of glasses for the LVFS treatment. As shown in FIG.
1, glasses, such as safety glasses or goggles, are taped or covered
so that they permit vision to only one lateral visual field at a
time. The patient is asked to look to one side and to fixate the
center of his vision on the edge of the tape so that he or she is
looking out of the lateral half of one eye. Vision from the other
eye is occluded by the tape on the other side. While looking out of
the specific visual field, the patient is asked to look at a
photograph of a man or woman with a mildly angry facial expression.
After 45 seconds, he or she is asked to verbally rate his or her
present feelings for each of 10 affects from Positive and Negative
Affect Scale (PANAS), from none to extreme on a 5 point scale.
Following the PANAS measurements, the patient is asked to rest for
1 minute looking straight ahead so that vision from both eyes is
occluded. The patient is then asked to repeat the procedure by
looking out of the second visual field.
[0109] The PANAS has 5 positive affects including alert, inspired,
determined, attentive, active and 5 negative affects including
upset, hostile, ashamed, nervous, afraid. For each visual field,
the sum of the scores on the 5 negative affects is subtracted from
the scores from the 5 positive affects and the difference is the
PANAS score. The score measured when the person looks out of the
right lateral visual field (RVF) is subtracted from the score
measured when the person looks out of the left lateral visual field
(LFV). The LVF is indicative of the state of the right hemisphere
since the connection between the medial retinas and the cerebral
hemispheres are crossed. Since a more positive PANAS score
indicates more positive affect, we assign a value for the person's
HEV according to the formula: LVF PANAS score--RVF PANAS. A
positive score suggests that the right hemisphere has a more
positive HEV. Research studies show that LVFS offers a good
indication that the left and right cerebral hemispheres are
generally associated with different emotional valences such that
one hemisphere (either left or right) is associated with a more
positive outlook on the world (positive hemispheric valence) and
the other a more negative outlook on the world (negative
hemispheric valence).
[0110] A person's personality and some of the person's
psychological characteristics may be affected by which hemisphere,
right or left hemisphere, dominates. The eyes are connected to the
brain so that vision to the left side of a person goes first to the
opposite (right) hemisphere and vision to the right side of a
person goes first to the left hemisphere. One hemisphere can be
stimulated over the other by restricting vision to a portion of the
retina of an eye that is connected to a particular hemisphere of
the brain. For instance, LVFS has been shown by fMRI to induce a
very large increase in brain activity in the hemisphere opposite
the visual field, when the subject looked out of the left visual
field (LVF) and the right visual field (RVF). FIG. 2 shows images
of the brain having different activity in the left and right
cerebral hemispheres after looking out of the left and right
lateral visual fields. FIG. 2A shows brain activity after looking
out of the left half of the left eye. FIG. 2B shows brain activity
after looking out of the right half of the right eye. As an
example, a person looking out of one visual field might see another
person as very critical of him and he might feel very critical of
himself. Looking out the opposite visual field he is apt to see
another person as quite approving of him and he is apt to see
himself positively.
[0111] In an embodiment, the PANAS score may be used to determine
which hemisphere of the brain to treat for a psychological
disorder. Treating, or stimulating, one hemisphere of the brain at
a time may cause certain changes in the psychological state of a
person. These changes include, but are not limited to, a more
positive outlook and a reduction in a negative outlook. In one
embodiment, applying light over the upper side of the forehead
(over the dorsolateral prefrontal cortex) will stimulate the
hemisphere on that same side. In an embodiment, stimulating the
brain in the medial pre-frontal cortex (stimulating transcranially
on the forehead just above the eye on one side will inhibit the
limbic system on that same side. In some embodiments, applying
light on the forehead over the eye is likely to be emotionally
inhibitory. In other embodiments, applying light over the upper
side of the forehead (i.e., over the dorsolateral prefrontal
cortex) over the hemisphere with a positive valence is likely to be
helpful as would be treating over the medial pre-frontal cortex of
the other hemisphere (with a more negative valence) to inhibit the
limbic system of the hemisphere with a negative valence. With
clinical practice, one could expect to improve this art by learning
better locations and parameters for light treatments.
[0112] In an embodiment, diagnosing and treating one hemisphere of
the brain may only cause changes in the psychological state of a
person having a positive HEV. For example, treating the left
hemisphere may benefit those patients who had a positive left
hemispheric emotional valence (HEV), but not those with a negative
left HEV. On the other hand, treating the right hemisphere may
benefit those patients who had a positive right hemispheric
emotional valence (HEV), but not those with a negative right HEV.
In an embodiment, treating one hemisphere of the brain may only
cause changes in the psychological state of person having a
negative HEV. For example, treating the left hemisphere may benefit
those patients who had a negative left hemispheric emotional
valence (HEV), but not those with a positive left HEV. On the other
hand, treating the right hemisphere may benefit those patients who
had a negative right hemispheric emotional valence (HEV), but not
those with a positive right HEV. In an embodiment, treating one
hemisphere of the brain may cause changes in the psychological
state of person having an either a positive HEV or a negative HEV.
In an embodiment, diagnosis and treatment of a psychological
disorder may be specific for each particular disorder. For example,
treatment of anorexia may require treatment of the hemisphere with
a positive HEV while treatment of insomnia may require treatment of
the hemisphere with a negative HEV.
[0113] In an embodiment, the methods of the present disclosure may
include using light energy to treat a hemisphere of the brain. In
an embodiment, the light energy may include near infrared light
(NIR). During this procedure, subjects can wear protective eyewear
to prevent the light to be shined into their eyes. NIR light may,
in an embodiment, be applied using Photobiomodulation (PBM) in the
form of an LED, as shown in FIG. 3. FIG. 4 shows a close up of the
PBM device. FIG. 5 shows a control unit of the PBM device. The
control unit may contain a power supply. The power supply may be in
the form of a battery or it may be connected to a power outlet. In
an embodiment, the control unit may include at least one socket to
connect with a LED. In an embodiment, one socket and one LED may be
used to treat one location on a patient's head at a given time. In
an embodiment, more than one LED can be used to treat more than one
location on a patient's head at a given time. For example, in
stroke patients, NIR may be used over the entire head. A knob is
situated on the control unit to control the voltage to the LED. An
increase in the voltage may be associated with an increase in the
light being delivered.
[0114] In an embodiment, NIR light may be applied at a distance of
about 0 to 1000 mm from the skin. In an embodiment, NIR light may
be applied at a distance of about 4 mm from the skin. Placing the
NIR light at a distance of about 4 mm from the skin at a power
density of about 250 mW/cm.sup.2 allows an amount of NIR light and
intensity to be directed at a person's brain without causing harm
to the brain during a 4-minute treatment at a given site. This dose
may be safely delivered to other sites on the head in the same
treatment setting. This dose could be increased as long as it is
below the ANSI standard of about 320 mW/cm.sup.2 on the skin at
each site. It should be noted that the intensity of the NIR light
increases as the NIR light approaches the skin and decreases in
intensity by the square of the distance as the NIR light is moved
away from the skin. One reason for choosing the distance of about 4
mm from the skin at a power density of about 250 mW/cm.sup.2 is
that the closer to the skin the more likely the LED will emit heat
that cannot be dissipated by the heat sink and fan. If the patient
can detect heat, placebo controlled studies may not be conducted as
the patient may know whether the LED light was on or off. Also, the
heat from the LED might cause the patient to feel pain the closer
the LED is to the patient. Additionally, too much light, without
heat, can cause damage to the skin. There is a conservative
standard for the permissible amount of light (photons) at near
infrared frequency of 810 nm, called the ANSI standard, as noted
above, and studies with NIR light below that standard will not
cause any harm to the patient.
[0115] During treatment, the light treatment device may be pulsed,
or the light treatment may be continuously applied. In certain
embodiments, the light treatment device may be combined with other
types of treatments for an improved therapeutic effect. Treatment
can include directing light through the scalp of the patient to a
target area of the brain concurrently with applying an
electromagnetic field to the brain. The light may be applied with a
desired power density and with a desired electromagnetic field
strength at the target area. In an embodiment, methods of treating
a psychiatric disorder may include non-invasively irradiating at
least a portion of a patient's brain with light energy having an
efficacious power density and wavelength, sufficient to cause a
neurotrophic effect and/or regulation of neurotransmitters. In
another embodiment, methods of treating a psychiatric disorder may
include non-invasively irradiating at least a portion of a
patient's brain with light energy having an efficacious power
density and wavelength, sufficient to cause a neurotrophic effect
and/or regulation of neurotransmitters, and delivering the light
energy for one or more treatment periods occurring over the course
of at least one week, each treatment period having a duration of at
least about 1 minute.
[0116] In an embodiment, the NIR light may be pulsed when applied
to the skin. Pulsing the NIR light can allow the use of a more
intense light and yet remain below the ANSI standard. Pulsing the
NIR light may be used to entrain the brain and thereby affect the
state of the brain. A faster entrainment can increase brain
activity, and a slower entrainment can decrease brain activity.
[0117] The light output may be continuously applied at about 250
mW/cm.sup.2 at a wavelength of about 810 nm with a full width half
maximum of about 40 nm. In an embodiment, the NIR light may be
directed at a person's brain for about 4 minutes (total delivered
fluence per spot of 60 J/cm.sup.2). In an embodiment, the procedure
with the NIR light may be repeated at at least one other site on
the forehead. In an embodiment, the NIR light may penetrate the
dura, or the outermost of the three layers of the meninges
surrounding the brain, at about 3.7%. In accordance with a
penetration of about 3.7%, approximately 2.1 J/cm.sup.2 of fluence
is delivered to each of the treated areas of the brain. It should
be noted that the level of light exposure is below the ANSI
standard of 320 mW/cm.sup.2. The level of light exposure either to
the skin (power density of 250 mW/cm.sup.2 and total fluence of 60
J/cm.sup.2), to the surface of the brain (power density of 9.5
mW/cm.sup.2 and total fluence of 2.1 J/cm.sup.2) and to each of the
2 treated areas of the forehead poses no significant risk to the
skin or the brain. It should be noted that while described above
with a specific frequency, the invention of the present disclosure
could also use a frequency from about 300 nm to about 1500 nm.
Furthermore, the present invention can use any source of light,
whether low level laser or LED, so long as its duration and
intensity are below the ANSI standard of 320 mW/cm.sup.2 on the
skin.
[0118] The methods of the present disclosure may affect blood flow
within the brain. Blood flow in the brain can be measured in left
and right frontal poles by NIRS, by a blood flow monitoring device,
such as a Somanetics INVOS system, modified by Somanetics to
provide total hemoglobin (cHb). In an embodiment, the blood flow
monitoring device uses a low power NIR LED. The blood flow
monitoring device has no effect on the brain. The blood flow
monitoring device measures the amount of blood in the brain once a
second. In an embodiment, the Somanetics devices measures oxy- and
deoxy-hemoglobin. The blood flow monitoring device poses no harm or
discomfort to subjects and allows subjects to have relatively free
movement. The blood flow monitoring device can be used to monitor
cHb in the left and right frontal poles during PBM. Since the PBM
used in an embodiment of the present disclosure is a continuous
wave, the light from the PBM is not detected by this NIRS device
because it has a proprietary mechanism for excluding continuous
light so that sunlight does not affect the device's pulsed photon
emitter. It should be noted that the Somanetics device is FDA
approved, is commercially available, and is used throughout the
world in hospital settings to monitor cerebral perfusion.
[0119] In an embodiment, cHb can be measured by NIRS during
treatments at at least one point. In an embodiment, there may be a
correlation between NIR and improved cHb and mood. For example,
there may be greater total (left plus right) cHb during NIR on
versus off as shown in FIG. 6. FIG. 7 shows that there was a
significantly more positive affect when the hemisphere with a
positive HEV was treated with NIR-PBM and a significantly more
negative affect after a hemisphere with a negative HEV was treated.
In FIG. 7, "matched" refers to treating the hemisphere with a
positive HEV and "unmatched" refers to treating the hemisphere with
a negative HEV. PANAS scores declined when the negative hemisphere
was treated. Thus, in a blind, placebo-controlled secondary study,
the PANAS scores improved on the PANAS items, following NIR
treatments to the hemisphere with a more positive HEV. The PANAS
scores correlated very highly with the HEV values times agreement
(1) or disagreement (-1) with the side treated.
[0120] The increase in cHb with NIR suggests that the NIR treatment
is affecting the brain. The improvement in PANAS immediately
following the treatment may indicate that this effect on the brain
likely relates to the alterations in affect. FIG. 8 shows that at
2-weeks post treatment, a decrease in anxiety (as measured by the
Hamilton Anxiety Rating Scale) was related to the patient's
baseline HEV and cerebral blood flow (CBF). In an embodiment,
patients with a left negative HEV and an increase in right frontal
CBF had less anxiety. In an embodiment, patients with a right
negative HEV and an increase in left frontal CBF had less anxiety.
Thus, patients who had an increase in blood flow in their positive
hemisphere did better at 2-weeks post treatment. If a person has a
negative side, increasing the blood flow on the opposite side can
have a beneficial effect at 2-weeks post treatment. The fact that
the outcomes at 2-weeks were dependent in regression models on the
baseline HEV value is consistent with the fact that right
hemisphere is often associated with a positive HEV (in opposition
to the popular notion that negative affect and/or cognition are
associated always with the right hemisphere) and that knowing a
patient's HEV can enlighten data reduction and guide treatment.
Cerebral blood flow correlates with brain activity in the front of
the brain. Patients with a negative right HEV and an increased left
CBF and patients with a negative left HEV and an increased right
CBF may have significantly better outcomes in terms of their
Hamilton Anxiety Rating Scale scores at 2-weeks post NIR
treatment.
[0121] Several theories may help explain the possible correlation
between NIR light and improved cHb and mood. NIR light is known to
increase and/or stimulate mitochondrial ATP and nerve growth
factors. This may be because the energy from the NIR light may be
absorbed by the mitochondria, which are the energy production
centers of the brain. Increasing and/or stimulating mitochondria
and mitochondrial ATP may help stimulate the positive neural
circuits or inhibit the negative neural circuits. It is further
known that light therapies may promote wound healing or reduce the
damage from strokes or heart attacks. Such studies were conducted
in rats and rabbits.
[0122] It should be noted that patients who were treated
bilaterally with the methods of the present disclosure experienced
a remission of anxieties at a rate of about seventy percent.
Remission refers to the state of absence of disease activity in
patients with a chronic illness. Remission is measured using a
rating scale where a score of greater than fifteen on the rating
scale correlates to having an anxiety disorder and a score of ten
or less on the rating scale correlates to being in remission and no
longer manifesting an abnormal level of anxiety. Compared to other
treatments, a remission rate of about seventy percent is very high.
On the Hamilton Depression Scale there was an average percent
decrease (percent less depression) of 54% 2-weeks after the single
treatment, and on the Hamilton Anxiety Rating Scale, at 2-weeks
post treatment, there was a percent decrease of 63%. These also
compare well with other treatments. For example, studies have found
that after 29 patients with an anxiety disorder were treated with
cognitive behavioral therapy for 30 weeks, those 29 patients
achieved a 51% reduction on the Hamilton Anxiety Rating Scale at
the end of the treatment. In addition, studies have found that
after 28 patients having an anxiety disorder were treated with
short-term psychodynamic psychotherapy for 30 weeks, those 28
patients achieved a 43% reduction on this anxiety rating scale at
the end of the treatment. In an embodiment, the methods of the
present disclosure treats patients with light therapy for a total
of about 8 minutes, is pain free, and without any observed side
effects, and is generally inexpensive.
[0123] According to aspects illustrated herein, there is provided a
method for treating psychiatric disorders using light energy,
including determining which hemisphere of the brain requires
treatment using lateral visual field stimulation (LVFS) and
applying light energy to the hemisphere of the brain to treat the
psychiatric disorder other than depression. In an embodiment, light
energy may include near infrared light (NIR). The methods of the
present disclosure may be used to treat a variety of psychiatric
disorders.
[0124] According to aspects illustrated herein, there is provided a
method for treating a psychiatric disorder in a patient, including
measuring a left hemispheric emotional valence and a right
hemispheric emotional valence for a left hemisphere of the brain
and a right hemisphere of the brain using a lateral visual field
stimulation test; determining which hemisphere of the brain needs
treatment; and applying light energy to the hemisphere of the brain
to treat the psychiatric disorder co-morbid with depression.
[0125] According to aspects illustrated herein, there is provided a
method for treating a psychiatric disorder in a patient, including
measuring a left hemispheric emotional valence for a left
hemisphere of the brain and a right hemispheric emotional valence
for a right hemisphere of the brain using a lateral visual field
stimulation test; determining the hemisphere of the brain in need
of treatment; and applying light energy to the hemisphere of the
brain to treat the psychiatric disorder co-morbid with
depression.
[0126] According to aspects illustrated herein, there is provided a
method for treating psychiatric disorders using light energy
including determining which hemisphere of the brain has a more
positive affect using lateral visual field stimulation (LVFS) and
applying light energy to the hemisphere with the more positive
affect. In an embodiment, light energy may include near infrared
light (NIR). The methods of the present disclosure may be used to
treat a variety of psychiatric disorders.
[0127] According to aspects illustrated herein, there is provided a
method for treating psychiatric disorders using light energy
including determining which hemisphere of the brain has a more
negative affect using lateral visual field stimulation (LVFS) and
applying light energy to the hemisphere with the more negative
affect to improve its functioning. In an embodiment, light energy
may include near infrared light (NIR). The methods of the present
disclosure may be used to treat a variety of psychiatric
disorders.
[0128] According to aspects illustrated herein, there is provided a
method for treating psychiatric disorders using light energy
including determining which hemisphere of the brain has a more
positive and negative affect using lateral visual field stimulation
(LVFS); applying light energy to the hemisphere with the more
positive affect; and applying light energy to the hemisphere with
the more negative effect. In an embodiment, if both hemispheres
have about equal levels of positive or negative affects, both
hemispheres may benefit from the light energy. In an embodiment,
light energy may include near infrared light (NIR). The methods of
the present disclosure may be used to treat a variety of
psychiatric disorders.
[0129] According to aspects illustrated herein, there is provided a
method for treating psychiatric disorders using light energy
including determining which hemisphere of the brain has a more
negative affect using lateral visual field stimulation (LVFS);
applying light energy to the hemisphere with the more negative
affect; and increasing cerebral blood flow in the opposing
hemisphere. In an embodiment, light energy may include near
infrared light (NIR). The methods of the present disclosure may be
used to treat a variety of psychiatric disorders.
[0130] According to aspects illustrated herein, there is provided
method for treating a patient, including determining which portion
of the brain of the patient requires treatment; and applying light
energy to the portion to treat the patient. The light might be
applied bilaterally over the left and the right dorsolateral
pre-frontal corticies. In an embodiment, the treatment may be used
to treat depression. In another embodiment, the treatment may be
used to improve the well-being of the patient.
[0131] According to aspects illustrated herein, there is provided a
method for treating a patient, including determining which portion
of the brain needs treatment; and applying light energy to the
portion of the brain to treat the patient. In an embodiment, the
treatment may be used to treat depression. In an embodiment, the
treatment may be used to cause an improvement in the well-being of
the patient.
[0132] According to aspects illustrated herein, there is provided a
method for treating a psychiatric disorder in a patient including
applying light energy to a brain to treat the psychiatric
disorder.
[0133] All patents, patent applications, and published references
cited herein are hereby incorporated by reference in their
entirety. It will be appreciated that several of the
above-disclosed and other features and functions, or alternatives
thereof, may be desirably combined into many other different
systems or applications. Various presently unforeseen or
unanticipated alternatives, modifications, variations, or
improvements therein may be subsequently made by those skilled in
the art.
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