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Near-Infrared Laser Stimulation for Various Neurological Conditions

Primary Purpose

Refractory Depression, Anxiety Disorders, Neurodegenerative Diseases

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Near Infrared Laser Stimulation
Sponsored by
Neurological Associates of West Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria (depression):

  • Diagnosis of Major Depressive Disorder
  • Score greater than 13 on the Beck Depression Inventory
  • Failure to remit with 3 antidepressants
  • At least 18 years of age

Inclusion Criteria (anxiety):

  • Diagnosis of Generalized or Acute Anxiety Disorder
  • Score greater than 22 on the Beck Anxiety Inventory
  • Failure to remit with 3 anxiolytics
  • At least 18 years of age

Inclusion Criteria (neurodegenerative dementia):

  • Cognitive decline with mild cognitive impairment (Clinical Dementia Rating stage 0.5) through moderate dementia (CDR stage 2)
  • Lumbar puncture for Abeta 42 and Tau proteins evincing clinical correlation of neurodegenerative disease pathology
  • Advanced MRI of the brain including volume measurement of the hippocampus, blood-oxygen level dependent imaging, and arterial spin labeling perfusion scans. On entry, patients will have CDR stage of at least 0.5 and at least one abnormal imaging biomarker.

Inclusion criteria (TBI/CTE):

  • Diagnosis of Traumatic Brain Injury or Chronic Traumatic Encephalopathy
  • At least 18 years of age

Exclusion Criteria:

  • Macular degeneration
  • Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
  • Advanced kidney, pulmonary, cardiac or liver failure
  • Advanced terminal illness
  • Any active cancer or chemotherapy
  • Bone marrow disorder
  • Myeloproliferative disorder
  • Sickle cell disease
  • Primary pulmonary hypertension
  • Immunocompromising conditions and/or immunosuppressive therapies
  • Any other neoplastic illness or illness characterized by neovascularity
  • Subjects unable to give informed consent
  • Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep
  • Recent surgery or dental work within 3 months of the scheduled procedure.
  • Pregnancy, women who may become pregnant or are breastfeeding

Sites / Locations

  • Neurological Associates of West Los Angele

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Near Infrared Laser Therapy

Arm Description

On the days of each near-infrared therapy session, patients will undergo 10 minutes of transcranial infrared laser stimulation. The laser dose for all conditions will be a 3.4 W continuous laser wave, at a 1064 wavelength, with irradiance (power density) at 250 milli-Watts/cm2. All groups will have treatment once a week (10 minutes per session) for 5-6 weeks. For Alzheimer's, the site targeted will be the right prefrontal cortex. Parkinson's patients will have laser delivered to the brain stem, bilateral temporal lobes. TBI/CTE patients will have the laser stimulation site dependent on location of injury. Patients with depression/anxiety will have laser stimulation applied to the prefrontal area of the head.

Outcomes

Primary Outcome Measures

[Depression (MDD)] Beck Depression Inventory (BDI-II)
The BDI-II is a 21-question multiple-choice self-report inventory. Each question involves four possible responses, ranging in intensity from "0" (this item does not apply) to "3" (this item applies severely). The test is scored as the sum of all of the response values; this number is used to determine the severity of depressive symptoms. A score of 0 to 3 is possible for each question with a maximum total score of 63 points. The standard cutoff scores are as follows: 0-13 total points = minimal depression; 14-19 total points = mild depression; 20-28 total points = moderate depression; and 29-63 total points = severe depression. A reduction in the total score by at least 30% is considered to be clinically significant.
[Anxiety] Beck Anxiety Inventory (BAI)
The BAI is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety symptoms. Each of the 21 items asks whether the patient has experienced various anxiety symptoms in the last two weeks, and if so, how severely. Each question/answer is scored on a scale value of "0" (not at all) to "3" (severely). Higher total scores indicate more severe anxiety symptoms. The maximum total score possible is 63 points. The standard cutoff scores are: 0-7 = minimal anxiety; 8-15 = mild anxiety; 16-25 = moderate anxiety; 26-63 = severe anxiety. A reduction in score by at least 30% is considered clinically meaningful.
[Dementia] Quick Dementia Rating Scale (QDRS)
The Quick Dementia Rating Scale (QDRS) is an interview-based tool administered by study officials to participants' caregivers used to obtain observations from a consistent source. The QDRS form consists of 10 categorical questions (5 cognitive, 5 functional), each with 5 detailed options depicting the level of impairment as either 0 (normal), 0.5 (mild/inconsistent impairment), 1 (mild/consistent impairment), 2 (moderate impairment), or 3 (severe impairment). Based on the conversion table outlined in Dr. James Galvin's research (2015), total QDRS scores were converted to Clinical Dementia Rating (CDR) scale levels ranging from 0 (normal aging), 0.5 (mild cognitive impairment), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia).
[Concussion/Traumatic Brain Injury (TBI)] Brief Pain Inventory (BPI)
Self-report measure containing a composite pain score and functional interference score. The pain subscale contains 4 questions, each with answers ranging from 0 'no pain' to 10 'pain as bad as you can imagine.' Total possible score for the pain subscale is 40 points. The functional/interference subscale contains 7 questions, with each answer ranging from 0 'does not interfere' to 10 'completely interferes.' The maximum possible score for the interference subscale is 70 points. The total overall composite BPI score is out of 100 maximum points. A clinical improvement is considered a decrease in BPI overall composite score by at least 30% from baseline.
[All] Global Rating of Change (GRC)
The GRC consists of a single likert-scale ranging from "-5" (very much worse) to "0" (neutral/no change) to "5" (very much better). The GRC is obtained in an interview format to assess a patient's perceived change in status following a treatment. A score that is at least 2 or greater is considered to indicate clinically significant change.

Secondary Outcome Measures

[MDD & TBI] Patient Depression Questionnaire (PDQ-9)
The PDQ-9 is a 9-item, self-report questionnaire to evaluate for depressive symptoms. Each question asks the patient if they have experienced a particular depressive symptom over the past two weeks. Answers may range from "0" (not at all), "1" (several days/week), "2" (more than half of the days), and "3" (nearly every day). Maximum total score is 27 points. A higher score indicates more severe depressive symptoms. A reduction in total score by at least 30% is considered clinically meaningful.
[MDD & TBI] Patient Depression Questionnaire (PDQ-9)
The PDQ-9 is a 9-item, self-report questionnaire to evaluate for depressive symptoms. Each question asks the patient if they have experienced a particular depressive symptom over the past two weeks. Answers may range from "0" (not at all), "1" (several days/week), "2" (more than half of the days), and "3" (nearly every day). Maximum total score is 27 points. A higher score indicates more severe depressive symptoms. A reduction in total score by at least 30% is considered clinically meaningful.
[MDD] Hamilton Depression Rating Scale (HAM-D)
The HAM-D is a 17-item, interview style questionnaire. A trained staff member administers this form to a patient and scores the patients' responses on a scale of "0" (symptom absent) to "4" (most severe option per symptom). A higher total score indicates a more severe level of depression. The maximum possible score is 50 points. A change in score of at least 30% is considered clinically meaningful.
[MDD] Hamilton Depression Rating Scale (HAM-D)
The HAM-D is a 17-item, interview style questionnaire. A trained staff member administers this form to a patient and scores the patients' responses on a scale of "0" (symptom absent) to "4" (most severe option per symptom). A higher total score indicates a more severe level of depression. The maximum possible score is 50 points. A change in score of at least 30% is considered clinically meaningful.
[Anxiety] Hamilton Anxiety Rating Scale (HAM-A)
The HAM-A is an observer/rater scale consisting of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
[Anxiety] Hamilton Anxiety Rating Scale (HAM-A)
The HAM-A is an observer/rater scale consisting of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
[Dementia] Repeatable Battery Assessment of Neuropsychological Status (RBANS) versions A-D
RBANS assesses immediate memory, visuospatial skill, language, attention, and delayed memory. Patient performance on each subscale immediate memory, language, attention, visuospatial, and delayed memory are scored relative to validated norms for same-aged peers. A change of 8+ points in the Total Scale score, 11+ points in the Immediate Memory score, 9+ points in the Language score, 4+ points on the Attention score, 14+ points is considered significant for the Visuospatial score, and 10+ points for the Delayed Memory score are considered significant.
[Dementia] Repeatable Battery Assessment of Neuropsychological Status (RBANS) versions A-D
RBANS assesses immediate memory, visuospatial skill, language, attention, and delayed memory. Patient performance on each subscale immediate memory, language, attention, visuospatial, and delayed memory are scored relative to validated norms for same-aged peers. A change of 8+ points in the Total Scale score, 11+ points in the Immediate Memory score, 9+ points in the Language score, 4+ points on the Attention score, 14+ points is considered significant for the Visuospatial score, and 10+ points for the Delayed Memory score are considered significant.
[Dementia] Montreal Cognitive Assessment (MoCA) versions 7.1-7.3
The MoCA evaluates frontal-executive functions (e.g., verbal abstraction and mental calculation), language (e.g., confrontation naming, phonemic fluency), orientation (e.g., person, place, date, day of the week, and time), visuospatial construction (e.g., simple figure copy), divided visual attention, and immediate and delayed memory of unstructured information. MoCA scores range from 0-30 possible points; 26 or greater is considered to reflect normal cognitive status.
[Dementia] Montreal Cognitive Assessment (MoCA) versions 7.1-7.3
The MoCA evaluates frontal-executive functions (e.g., verbal abstraction and mental calculation), language (e.g., confrontation naming, phonemic fluency), orientation (e.g., person, place, date, day of the week, and time), visuospatial construction (e.g., simple figure copy), divided visual attention, and immediate and delayed memory of unstructured information. MoCA scores range from 0-30 possible points; 26 or greater is considered to reflect normal cognitive status.
[MDD] Beck Depression Inventory (BDI-II)
The BDI-II is a 21-question multiple-choice self-report inventory. Each question involves four possible responses, ranging in intensity from "0" (this item does not apply) to "3" (this item applies severely). The test is scored as the sum of all of the response values; this number is used to determine the severity of depressive symptoms. A score of 0 to 3 is possible for each question with a maximum total score of 63 points. The standard cutoff scores are as follows: 0-13 total points = minimal depression; 14-19 total points = mild depression; 20-28 total points = moderate depression; and 29-63 total points = severe depression. A reduction in the total score by at least 30% is considered to be clinically significant.
[Anxiety] Beck Anxiety Inventory (BAI)
The BAI is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety symptoms. Each of the 21 items asks whether the patient has experienced various anxiety symptoms in the last two weeks, and if so, how severely. Each question/answer is scored on a scale value of "0" (not at all) to "3" (severely). Higher total scores indicate more severe anxiety symptoms. The maximum total score possible is 63 points. The standard cutoff scores are: 0-7 = minimal anxiety; 8-15 = mild anxiety; 16-25 = moderate anxiety; 26-63 = severe anxiety. A reduction in score by at least 30% is considered clinically meaningful.
[Dementia] Quick Dementia Rating Scale (QDRS)
The Quick Dementia Rating Scale (QDRS) is an interview-based tool administered by study officials to participants' caregivers used to obtain observations from a consistent source. The QDRS form consists of 10 categorical questions (5 cognitive, 5 functional), each with 5 detailed options depicting the level of impairment as either 0 (normal), 0.5 (mild/inconsistent impairment), 1 (mild/consistent impairment), 2 (moderate impairment), or 3 (severe impairment). Based on the conversion table outlined in Dr. James Galvin's research (2015), total QDRS scores were converted to Clinical Dementia Rating (CDR) scale levels ranging from 0 (normal aging), 0.5 (mild cognitive impairment), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia).
[TBI] Brief Pain Inventory (BPI)
Self-report measure containing a composite pain score and functional interference score. The pain subscale contains 4 questions, each with answers ranging from 0 'no pain' to 10 'pain as bad as you can imagine.' Total possible score for the pain subscale is 40 points. The functional/interference subscale contains 7 questions, with each answer ranging from 0 'does not interfere' to 10 'completely interferes.' The maximum possible score for the interference subscale is 70 points. The total overall composite BPI score is out of 100 maximum points. A clinical improvement is considered a decrease in BPI overall composite score by at least 30% from baseline.
[All] Global Rating of Change (GRC)
The GRC consists of a single likert-scale ranging from "-5" (very much worse) to "0" (neutral/no change) to "5" (very much better). The GRC is obtained in an interview format to assess a patient's perceived change in status following a treatment. A score that is at least 2 or greater is considered to indicate clinically significant change.

Full Information

First Posted
July 21, 2020
Last Updated
September 26, 2022
Sponsor
Neurological Associates of West Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT04489082
Brief Title
Near-Infrared Laser Stimulation for Various Neurological Conditions
Official Title
Use of Near Infrared Laser Stimulation for Treatment of Depression, Anxiety, Neurodegenerative Conditions, and Traumatic Brain Injury/Chronic Traumatic Encephalopathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 2, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurological Associates of West Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will evaluate the safety and feasibility of near infrared therapy as an intervention for patients with refractory depression, anxiety, neurodegenerative disease, and traumatic brain injury.
Detailed Description
The present study is being undertaken as an open-label study to evaluate the safety and feasibility of near infrared therapy as an intervention for patients with refractory depression, anxiety, cognitive impairment due to a neurodegenerative disease (e.g., Alzheimer's), and traumatic brain injury. Baseline and outcome measures in this study utilize validated tests that are appropriate for repeated measures. The present study can be easily implemented because instruments have been in routine clinical deployment providing for a high degree of availability and reliability. Quality assurance is tightly controlled. The study population is sufficiently broad and the conditions of interest are sufficiently prevalent so that recruitment of subjects is not a limiting factor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Depression, Anxiety Disorders, Neurodegenerative Diseases, Traumatic Brain Injury, Chronic Traumatic Encephalopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The present study is being undertaken as an open-label study to evaluate the safety and feasibility of near infrared therapy as an intervention for patients with refractory depression, anxiety, cognitive impairment due to a neurodegenerative disease (e.g., Alzheimer's), and traumatic brain injury.
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Near Infrared Laser Therapy
Arm Type
Experimental
Arm Description
On the days of each near-infrared therapy session, patients will undergo 10 minutes of transcranial infrared laser stimulation. The laser dose for all conditions will be a 3.4 W continuous laser wave, at a 1064 wavelength, with irradiance (power density) at 250 milli-Watts/cm2. All groups will have treatment once a week (10 minutes per session) for 5-6 weeks. For Alzheimer's, the site targeted will be the right prefrontal cortex. Parkinson's patients will have laser delivered to the brain stem, bilateral temporal lobes. TBI/CTE patients will have the laser stimulation site dependent on location of injury. Patients with depression/anxiety will have laser stimulation applied to the prefrontal area of the head.
Intervention Type
Device
Intervention Name(s)
Near Infrared Laser Stimulation
Intervention Description
10 minutes of transcranial near infrared laser stimulation
Primary Outcome Measure Information:
Title
[Depression (MDD)] Beck Depression Inventory (BDI-II)
Description
The BDI-II is a 21-question multiple-choice self-report inventory. Each question involves four possible responses, ranging in intensity from "0" (this item does not apply) to "3" (this item applies severely). The test is scored as the sum of all of the response values; this number is used to determine the severity of depressive symptoms. A score of 0 to 3 is possible for each question with a maximum total score of 63 points. The standard cutoff scores are as follows: 0-13 total points = minimal depression; 14-19 total points = mild depression; 20-28 total points = moderate depression; and 29-63 total points = severe depression. A reduction in the total score by at least 30% is considered to be clinically significant.
Time Frame
6 weeks
Title
[Anxiety] Beck Anxiety Inventory (BAI)
Description
The BAI is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety symptoms. Each of the 21 items asks whether the patient has experienced various anxiety symptoms in the last two weeks, and if so, how severely. Each question/answer is scored on a scale value of "0" (not at all) to "3" (severely). Higher total scores indicate more severe anxiety symptoms. The maximum total score possible is 63 points. The standard cutoff scores are: 0-7 = minimal anxiety; 8-15 = mild anxiety; 16-25 = moderate anxiety; 26-63 = severe anxiety. A reduction in score by at least 30% is considered clinically meaningful.
Time Frame
6 weeks
Title
[Dementia] Quick Dementia Rating Scale (QDRS)
Description
The Quick Dementia Rating Scale (QDRS) is an interview-based tool administered by study officials to participants' caregivers used to obtain observations from a consistent source. The QDRS form consists of 10 categorical questions (5 cognitive, 5 functional), each with 5 detailed options depicting the level of impairment as either 0 (normal), 0.5 (mild/inconsistent impairment), 1 (mild/consistent impairment), 2 (moderate impairment), or 3 (severe impairment). Based on the conversion table outlined in Dr. James Galvin's research (2015), total QDRS scores were converted to Clinical Dementia Rating (CDR) scale levels ranging from 0 (normal aging), 0.5 (mild cognitive impairment), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia).
Time Frame
6 weeks
Title
[Concussion/Traumatic Brain Injury (TBI)] Brief Pain Inventory (BPI)
Description
Self-report measure containing a composite pain score and functional interference score. The pain subscale contains 4 questions, each with answers ranging from 0 'no pain' to 10 'pain as bad as you can imagine.' Total possible score for the pain subscale is 40 points. The functional/interference subscale contains 7 questions, with each answer ranging from 0 'does not interfere' to 10 'completely interferes.' The maximum possible score for the interference subscale is 70 points. The total overall composite BPI score is out of 100 maximum points. A clinical improvement is considered a decrease in BPI overall composite score by at least 30% from baseline.
Time Frame
6 weeks
Title
[All] Global Rating of Change (GRC)
Description
The GRC consists of a single likert-scale ranging from "-5" (very much worse) to "0" (neutral/no change) to "5" (very much better). The GRC is obtained in an interview format to assess a patient's perceived change in status following a treatment. A score that is at least 2 or greater is considered to indicate clinically significant change.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
[MDD & TBI] Patient Depression Questionnaire (PDQ-9)
Description
The PDQ-9 is a 9-item, self-report questionnaire to evaluate for depressive symptoms. Each question asks the patient if they have experienced a particular depressive symptom over the past two weeks. Answers may range from "0" (not at all), "1" (several days/week), "2" (more than half of the days), and "3" (nearly every day). Maximum total score is 27 points. A higher score indicates more severe depressive symptoms. A reduction in total score by at least 30% is considered clinically meaningful.
Time Frame
6 weeks
Title
[MDD & TBI] Patient Depression Questionnaire (PDQ-9)
Description
The PDQ-9 is a 9-item, self-report questionnaire to evaluate for depressive symptoms. Each question asks the patient if they have experienced a particular depressive symptom over the past two weeks. Answers may range from "0" (not at all), "1" (several days/week), "2" (more than half of the days), and "3" (nearly every day). Maximum total score is 27 points. A higher score indicates more severe depressive symptoms. A reduction in total score by at least 30% is considered clinically meaningful.
Time Frame
4 weeks post last day of treatment
Title
[MDD] Hamilton Depression Rating Scale (HAM-D)
Description
The HAM-D is a 17-item, interview style questionnaire. A trained staff member administers this form to a patient and scores the patients' responses on a scale of "0" (symptom absent) to "4" (most severe option per symptom). A higher total score indicates a more severe level of depression. The maximum possible score is 50 points. A change in score of at least 30% is considered clinically meaningful.
Time Frame
6 weeks
Title
[MDD] Hamilton Depression Rating Scale (HAM-D)
Description
The HAM-D is a 17-item, interview style questionnaire. A trained staff member administers this form to a patient and scores the patients' responses on a scale of "0" (symptom absent) to "4" (most severe option per symptom). A higher total score indicates a more severe level of depression. The maximum possible score is 50 points. A change in score of at least 30% is considered clinically meaningful.
Time Frame
4 weeks post last day of treatment
Title
[Anxiety] Hamilton Anxiety Rating Scale (HAM-A)
Description
The HAM-A is an observer/rater scale consisting of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Time Frame
6 weeks
Title
[Anxiety] Hamilton Anxiety Rating Scale (HAM-A)
Description
The HAM-A is an observer/rater scale consisting of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Time Frame
4 weeks post last day of treatment
Title
[Dementia] Repeatable Battery Assessment of Neuropsychological Status (RBANS) versions A-D
Description
RBANS assesses immediate memory, visuospatial skill, language, attention, and delayed memory. Patient performance on each subscale immediate memory, language, attention, visuospatial, and delayed memory are scored relative to validated norms for same-aged peers. A change of 8+ points in the Total Scale score, 11+ points in the Immediate Memory score, 9+ points in the Language score, 4+ points on the Attention score, 14+ points is considered significant for the Visuospatial score, and 10+ points for the Delayed Memory score are considered significant.
Time Frame
6 weeks
Title
[Dementia] Repeatable Battery Assessment of Neuropsychological Status (RBANS) versions A-D
Description
RBANS assesses immediate memory, visuospatial skill, language, attention, and delayed memory. Patient performance on each subscale immediate memory, language, attention, visuospatial, and delayed memory are scored relative to validated norms for same-aged peers. A change of 8+ points in the Total Scale score, 11+ points in the Immediate Memory score, 9+ points in the Language score, 4+ points on the Attention score, 14+ points is considered significant for the Visuospatial score, and 10+ points for the Delayed Memory score are considered significant.
Time Frame
4 weeks post last day of treatment
Title
[Dementia] Montreal Cognitive Assessment (MoCA) versions 7.1-7.3
Description
The MoCA evaluates frontal-executive functions (e.g., verbal abstraction and mental calculation), language (e.g., confrontation naming, phonemic fluency), orientation (e.g., person, place, date, day of the week, and time), visuospatial construction (e.g., simple figure copy), divided visual attention, and immediate and delayed memory of unstructured information. MoCA scores range from 0-30 possible points; 26 or greater is considered to reflect normal cognitive status.
Time Frame
6 weeks
Title
[Dementia] Montreal Cognitive Assessment (MoCA) versions 7.1-7.3
Description
The MoCA evaluates frontal-executive functions (e.g., verbal abstraction and mental calculation), language (e.g., confrontation naming, phonemic fluency), orientation (e.g., person, place, date, day of the week, and time), visuospatial construction (e.g., simple figure copy), divided visual attention, and immediate and delayed memory of unstructured information. MoCA scores range from 0-30 possible points; 26 or greater is considered to reflect normal cognitive status.
Time Frame
4 weeks post last day of treatment
Title
[MDD] Beck Depression Inventory (BDI-II)
Description
The BDI-II is a 21-question multiple-choice self-report inventory. Each question involves four possible responses, ranging in intensity from "0" (this item does not apply) to "3" (this item applies severely). The test is scored as the sum of all of the response values; this number is used to determine the severity of depressive symptoms. A score of 0 to 3 is possible for each question with a maximum total score of 63 points. The standard cutoff scores are as follows: 0-13 total points = minimal depression; 14-19 total points = mild depression; 20-28 total points = moderate depression; and 29-63 total points = severe depression. A reduction in the total score by at least 30% is considered to be clinically significant.
Time Frame
4 weeks post last day of treatment
Title
[Anxiety] Beck Anxiety Inventory (BAI)
Description
The BAI is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety symptoms. Each of the 21 items asks whether the patient has experienced various anxiety symptoms in the last two weeks, and if so, how severely. Each question/answer is scored on a scale value of "0" (not at all) to "3" (severely). Higher total scores indicate more severe anxiety symptoms. The maximum total score possible is 63 points. The standard cutoff scores are: 0-7 = minimal anxiety; 8-15 = mild anxiety; 16-25 = moderate anxiety; 26-63 = severe anxiety. A reduction in score by at least 30% is considered clinically meaningful.
Time Frame
4 weeks post last day of treatment
Title
[Dementia] Quick Dementia Rating Scale (QDRS)
Description
The Quick Dementia Rating Scale (QDRS) is an interview-based tool administered by study officials to participants' caregivers used to obtain observations from a consistent source. The QDRS form consists of 10 categorical questions (5 cognitive, 5 functional), each with 5 detailed options depicting the level of impairment as either 0 (normal), 0.5 (mild/inconsistent impairment), 1 (mild/consistent impairment), 2 (moderate impairment), or 3 (severe impairment). Based on the conversion table outlined in Dr. James Galvin's research (2015), total QDRS scores were converted to Clinical Dementia Rating (CDR) scale levels ranging from 0 (normal aging), 0.5 (mild cognitive impairment), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia).
Time Frame
4 weeks post last day of treatment
Title
[TBI] Brief Pain Inventory (BPI)
Description
Self-report measure containing a composite pain score and functional interference score. The pain subscale contains 4 questions, each with answers ranging from 0 'no pain' to 10 'pain as bad as you can imagine.' Total possible score for the pain subscale is 40 points. The functional/interference subscale contains 7 questions, with each answer ranging from 0 'does not interfere' to 10 'completely interferes.' The maximum possible score for the interference subscale is 70 points. The total overall composite BPI score is out of 100 maximum points. A clinical improvement is considered a decrease in BPI overall composite score by at least 30% from baseline.
Time Frame
4 weeks post last day of treatment
Title
[All] Global Rating of Change (GRC)
Description
The GRC consists of a single likert-scale ranging from "-5" (very much worse) to "0" (neutral/no change) to "5" (very much better). The GRC is obtained in an interview format to assess a patient's perceived change in status following a treatment. A score that is at least 2 or greater is considered to indicate clinically significant change.
Time Frame
4 weeks post last day of treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (depression): Diagnosis of Major Depressive Disorder Score greater than 13 on the Beck Depression Inventory Failure to remit with 3 antidepressants At least 18 years of age Inclusion Criteria (anxiety): Diagnosis of Generalized or Acute Anxiety Disorder Score greater than 22 on the Beck Anxiety Inventory Failure to remit with 3 anxiolytics At least 18 years of age Inclusion Criteria (neurodegenerative dementia): Cognitive decline with mild cognitive impairment (Clinical Dementia Rating stage 0.5) through moderate dementia (CDR stage 2) Lumbar puncture for Abeta 42 and Tau proteins evincing clinical correlation of neurodegenerative disease pathology Advanced MRI of the brain including volume measurement of the hippocampus, blood-oxygen level dependent imaging, and arterial spin labeling perfusion scans. On entry, patients will have CDR stage of at least 0.5 and at least one abnormal imaging biomarker. Inclusion criteria (TBI/CTE): Diagnosis of Traumatic Brain Injury or Chronic Traumatic Encephalopathy At least 18 years of age Exclusion Criteria: Macular degeneration Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer) Advanced kidney, pulmonary, cardiac or liver failure Advanced terminal illness Any active cancer or chemotherapy Bone marrow disorder Myeloproliferative disorder Sickle cell disease Primary pulmonary hypertension Immunocompromising conditions and/or immunosuppressive therapies Any other neoplastic illness or illness characterized by neovascularity Subjects unable to give informed consent Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep Recent surgery or dental work within 3 months of the scheduled procedure. Pregnancy, women who may become pregnant or are breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheldon Jordan, M.D.
Organizational Affiliation
Neurological Associates of West Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurological Associates of West Los Angele
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data from this study will not be made publicly available due to ethical and privacy concerns. Anonymized data will be available upon reasonable request from any qualified investigator
Citations:
PubMed Identifier
31380975
Citation
Alosco ML, Stein TD, Tripodis Y, Chua AS, Kowall NW, Huber BR, Goldstein LE, Cantu RC, Katz DI, Palmisano JN, Martin B, Cherry JD, Mahar I, Killiany RJ, McClean MD, Au R, Alvarez V, Stern RA, Mez J, McKee AC. Association of White Matter Rarefaction, Arteriolosclerosis, and Tau With Dementia in Chronic Traumatic Encephalopathy. JAMA Neurol. 2019 Nov 1;76(11):1298-1308. doi: 10.1001/jamaneurol.2019.2244.
Results Reference
background
PubMed Identifier
28975240
Citation
Asken BM, Sullan MJ, DeKosky ST, Jaffee MS, Bauer RM. Research Gaps and Controversies in Chronic Traumatic Encephalopathy: A Review. JAMA Neurol. 2017 Oct 1;74(10):1255-1262. doi: 10.1001/jamaneurol.2017.2396.
Results Reference
background
PubMed Identifier
26487813
Citation
Bandelow B, Michaelis S. Epidemiology of anxiety disorders in the 21st century. Dialogues Clin Neurosci. 2015 Sep;17(3):327-35. doi: 10.31887/DCNS.2015.17.3/bbandelow.
Results Reference
background
PubMed Identifier
24398724
Citation
Chauhan NB. Chronic neurodegenerative consequences of traumatic brain injury. Restor Neurol Neurosci. 2014;32(2):337-65. doi: 10.3233/RNN-130354.
Results Reference
background
PubMed Identifier
19185342
Citation
Cipriani A, Furukawa TA, Salanti G, Geddes JR, Higgins JP, Churchill R, Watanabe N, Nakagawa A, Omori IM, McGuire H, Tansella M, Barbui C. Comparative efficacy and acceptability of 12 new-generation antidepressants: a multiple-treatments meta-analysis. Lancet. 2009 Feb 28;373(9665):746-58. doi: 10.1016/S0140-6736(09)60046-5.
Results Reference
background
PubMed Identifier
30850617
Citation
Coupe P, Manjon JV, Lanuza E, Catheline G. Lifespan Changes of the Human Brain In Alzheimer's Disease. Sci Rep. 2019 Mar 8;9(1):3998. doi: 10.1038/s41598-019-39809-8.
Results Reference
background
PubMed Identifier
31317824
Citation
Edwards G 3rd, Zhao J, Dash PK, Soto C, Moreno-Gonzalez I. Traumatic Brain Injury Induces Tau Aggregation and Spreading. J Neurotrauma. 2020 Jan 1;37(1):80-92. doi: 10.1089/neu.2018.6348. Epub 2019 Aug 28.
Results Reference
background
PubMed Identifier
24223526
Citation
Ferrari AJ, Charlson FJ, Norman RE, Patten SB, Freedman G, Murray CJ, Vos T, Whiteford HA. Burden of depressive disorders by country, sex, age, and year: findings from the global burden of disease study 2010. PLoS Med. 2013 Nov;10(11):e1001547. doi: 10.1371/journal.pmed.1001547. Epub 2013 Nov 5.
Results Reference
background
PubMed Identifier
28933211
Citation
Galgano M, Toshkezi G, Qiu X, Russell T, Chin L, Zhao LR. Traumatic Brain Injury: Current Treatment Strategies and Future Endeavors. Cell Transplant. 2017 Jul;26(7):1118-1130. doi: 10.1177/0963689717714102.
Results Reference
background
PubMed Identifier
27752476
Citation
Hamblin MR. Shining light on the head: Photobiomodulation for brain disorders. BBA Clin. 2016 Oct 1;6:113-124. doi: 10.1016/j.bbacli.2016.09.002. eCollection 2016 Dec.
Results Reference
background
PubMed Identifier
25581233
Citation
Montenigro PH, Corp DT, Stein TD, Cantu RC, Stern RA. Chronic traumatic encephalopathy: historical origins and current perspective. Annu Rev Clin Psychol. 2015;11:309-30. doi: 10.1146/annurev-clinpsy-032814-112814. Epub 2015 Jan 12.
Results Reference
background
PubMed Identifier
12103459
Citation
Montgomery SA, Baldwin DS, Riley A. Antidepressant medications: a review of the evidence for drug-induced sexual dysfunction. J Affect Disord. 2002 May;69(1-3):119-40. doi: 10.1016/s0165-0327(01)00313-5.
Results Reference
background
PubMed Identifier
30733666
Citation
Ni H, Yang S, Siaw-Debrah F, Hu J, Wu K, He Z, Yang J, Pan S, Lin X, Ye H, Xu Z, Wang F, Jin K, Zhuge Q, Huang L. Exosomes Derived From Bone Mesenchymal Stem Cells Ameliorate Early Inflammatory Responses Following Traumatic Brain Injury. Front Neurosci. 2019 Jan 24;13:14. doi: 10.3389/fnins.2019.00014. eCollection 2019.
Results Reference
background
PubMed Identifier
23806754
Citation
Rojas JC, Gonzalez-Lima F. Neurological and psychological applications of transcranial lasers and LEDs. Biochem Pharmacol. 2013 Aug 15;86(4):447-57. doi: 10.1016/j.bcp.2013.06.012. Epub 2013 Jun 24.
Results Reference
background
PubMed Identifier
17074942
Citation
Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.11.1905.
Results Reference
background
PubMed Identifier
31380933
Citation
Schneider JA. Multiple Pathologic Pathways to Dementia in Football Players With Chronic Traumatic Encephalopathy. JAMA Neurol. 2019 Nov 1;76(11):1283-1284. doi: 10.1001/jamaneurol.2019.1089. No abstract available.
Results Reference
background
PubMed Identifier
31504227
Citation
Takahata K, Kimura Y, Sahara N, Koga S, Shimada H, Ichise M, Saito F, Moriguchi S, Kitamura S, Kubota M, Umeda S, Niwa F, Mizushima J, Morimoto Y, Funayama M, Tabuchi H, Bieniek KF, Kawamura K, Zhang MR, Dickson DW, Mimura M, Kato M, Suhara T, Higuchi M. PET-detectable tau pathology correlates with long-term neuropsychiatric outcomes in patients with traumatic brain injury. Brain. 2019 Oct 1;142(10):3265-3279. doi: 10.1093/brain/awz238.
Results Reference
background
PubMed Identifier
28958355
Citation
Vella MA, Crandall ML, Patel MB. Acute Management of Traumatic Brain Injury. Surg Clin North Am. 2017 Oct;97(5):1015-1030. doi: 10.1016/j.suc.2017.06.003.
Results Reference
background
PubMed Identifier
28516328
Citation
Willis MD, Robertson NP. Chronic traumatic encephalopathy: identifying those at risk and understanding pathogenesis. J Neurol. 2017 Jun;264(6):1298-1300. doi: 10.1007/s00415-017-8508-x. No abstract available.
Results Reference
background

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Near-Infrared Laser Stimulation for Various Neurological Conditions

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