Trial Outcomes & Findings for Photobiomodulation for Improving Brain Function in Dementia (PBM Dementia) (NCT NCT03160027)

NCT ID: NCT03160027

Last Updated: 2020-10-06

Results Overview

The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) test is one of the most frequently used tests to measure cognition in research studies and clinical trials for new drugs and other interventions. It consists of 11 tasks measuring the disturbances of memory, language, praxis (e.g., ability to conceptualize, plan, and execute the complex sequences of motor actions), attention and other cognitive abilities which are often referred to as the core symptoms of AD. The ADAS-cog score is based on the number of errors made in each item. Total score ranges from 0 to 70. A score of 70 represents the most severe impairment. A score of 0 represents the least impairment. This outcome is a change score, derived by subtracting Baseline ADAS-cog score from Week 12 ADAS-cog score.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

change from baseline to 12 weeks

Results posted on

2020-10-06

Participant Flow

Participant milestones

Participant milestones
Measure	Immediate PBM Treatment - Patients This arm will receive photobiomodulation (PBM), delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks. Vielight Neuro Gamma: The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment.	Delayed PBM Treatment - Patients This arm will maintain usual activities for 12 weeks. After the week 12 psychometric and MRI assessment, this arm will receive PBM, delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks.	Immediate PBM Treatment - Caregivers This arm consists of the caregivers of patients who will receive photobiomodulation (PBM), delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes.	Delayed PBM Treatment - Caregivers This arm consists of caregivers of patients who will maintain usual activities for 12 weeks.
Overall Study STARTED	6	4	6	4
Overall Study COMPLETED	6	4	6	4
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Photobiomodulation for Improving Brain Function in Dementia (PBM Dementia)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immediate PBM Treatment - Patient n=6 Participants This arm will receive photobiomodulation (PBM), delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks. Vielight Neuro Gamma: The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment.	Immediate PBM Treatment - Study Partner n=6 Participants This arm will help administer photobiomodulation (PBM), delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks to the patient.	Delayed PBM Treatment - Patient n=4 Participants This arm will maintain usual activities for 12 weeks. After the week 12 psychometric and MRI assessment, this arm will receive PBM, delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks.	Delayed PBM Treatment - Study Partner n=4 Participants This arm will maintain usual activities for 12 weeks.	Total n=20 Participants Total of all reporting groups
Age, Continuous Age	78.3 years STANDARD_DEVIATION 10.2 • n=5 Participants	75.0 years STANDARD_DEVIATION 10.8 • n=7 Participants	79.0 years STANDARD_DEVIATION 5.9 • n=5 Participants	50.5 years STANDARD_DEVIATION 14.3 • n=4 Participants	78.6 years STANDARD_DEVIATION 8.3 • n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	11 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	20 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	4 participants n=5 Participants	4 participants n=4 Participants	10 participants n=21 Participants

PRIMARY outcome

Timeframe: change from baseline to 12 weeks

The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) test is one of the most frequently used tests to measure cognition in research studies and clinical trials for new drugs and other interventions. It consists of 11 tasks measuring the disturbances of memory, language, praxis (e.g., ability to conceptualize, plan, and execute the complex sequences of motor actions), attention and other cognitive abilities which are often referred to as the core symptoms of AD. The ADAS-cog score is based on the number of errors made in each item. Total score ranges from 0 to 70. A score of 70 represents the most severe impairment. A score of 0 represents the least impairment. This outcome is a change score, derived by subtracting Baseline ADAS-cog score from Week 12 ADAS-cog score.

Outcome measures

Outcome measures
Measure	Immediate PBM Treatment n=4 Participants This arm will receive photobiomodulation (PBM), delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks. Vielight Neuro Gamma: The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment.	Delayed PBM Treatment n=4 Participants This arm will maintain usual activities for 12 weeks. After the week 12 psychometric and MRI assessment, this arm will receive PBM, delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks.	Delayed PBM After 12 Weeks of PBM n=3 Participants Delayed PBM participants who opted to undergo 12 weeks of PBM treatments after 12 weeks of Usual Care
Change in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog)	5.8 units on the ADAS-cog scale Standard Deviation 1.7	-7.2 units on the ADAS-cog scale Standard Deviation 5.8	4.8 units on the ADAS-cog scale Standard Deviation 2.2

PRIMARY outcome

Timeframe: change from baseline to 12 weeks

The clock-drawing test is used for screening for cognitive impairment and dementia and as a measure of spatial dysfunction and neglect. The score ranges from 0 (none correct) to 5 (all correct). A score greater than or equal to 4 is considered "normal" The outcome is a change score: Baseline - Week 12 score. Or Week 12 - Week 24 for Delayed PBM participants who opted to undergo 12 weeks of PBM treatments after 12 weeks of Usual Care. A negative change score = improvement; a positive change score = decline.

Outcome measures

Outcome measures
Measure	Immediate PBM Treatment n=4 Participants This arm will receive photobiomodulation (PBM), delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks. Vielight Neuro Gamma: The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment.	Delayed PBM Treatment n=4 Participants This arm will maintain usual activities for 12 weeks. After the week 12 psychometric and MRI assessment, this arm will receive PBM, delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks.	Delayed PBM After 12 Weeks of PBM n=3 Participants Delayed PBM participants who opted to undergo 12 weeks of PBM treatments after 12 weeks of Usual Care
Change in Clock-drawing Test	0.3 units on clock-drawing test score Standard Deviation 1.3	0.5 units on clock-drawing test score Standard Deviation 1.0	0 units on clock-drawing test score Standard Deviation 0

PRIMARY outcome

Timeframe: change from baseline to 12 weeks

The DMN is a network of interacting brain regions known to have activity highly correlated with each other and distinct from other networks in the brain. This outcome consists of the strength of the connection between the posterior cingulate cortex (PCC), a hub of the DMN, and the left (L) and right (R) lateral parietal cortex (LP) at baseline and at Week 12. Studies in patients with Alzheimer's disease (AD) suggest there is diminished connectivity between nodes of the DMN in AD. Therefore increased connectivity between nodes of the DMN from baseline to Week 12 (or higher T-scores of the connection) indicate better outcomes. The measure type of "number" for this assessment is the T-score that was calculated for each "group".

Outcome measures

Outcome measures
Measure	Immediate PBM Treatment n=4 Participants This arm will receive photobiomodulation (PBM), delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks. Vielight Neuro Gamma: The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment.	Delayed PBM Treatment n=4 Participants This arm will maintain usual activities for 12 weeks. After the week 12 psychometric and MRI assessment, this arm will receive PBM, delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks.	Delayed PBM After 12 Weeks of PBM Delayed PBM participants who opted to undergo 12 weeks of PBM treatments after 12 weeks of Usual Care
Change in Default Mode Network (DMN) Functional Connectivity strength of connection bet. PCC & LLP at baseline	4.25 T-score	6.88 T-score	—
Change in Default Mode Network (DMN) Functional Connectivity strength of connection bet. PCC & LLP at Week 12	14.15 T-score	3.86 T-score	—
Change in Default Mode Network (DMN) Functional Connectivity strength of connection bet. PCC & RLP at baseline	3.98 T-score	8.34 T-score	—
Change in Default Mode Network (DMN) Functional Connectivity strength of connection bet. PCC & RLP at Week 12	11.17 T-score	5.04 T-score	—

PRIMARY outcome

Timeframe: change from baseline to 12 weeks

This outcome consists of measures of blood flow to the brain at baseline and at Week 12. Total perfusion values were derived by averaging across the superior frontal, superior parietal, and supramarginal regions of interest (ROI), based on the location of the transcranial LED clusters. The perfusion values were normalized to the precentral gyrus (i.e., motor cortex) perfusion .

Outcome measures

Outcome measures
Measure	Immediate PBM Treatment n=4 Participants This arm will receive photobiomodulation (PBM), delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks. Vielight Neuro Gamma: The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment.	Delayed PBM Treatment n=4 Participants This arm will maintain usual activities for 12 weeks. After the week 12 psychometric and MRI assessment, this arm will receive PBM, delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks.	Delayed PBM After 12 Weeks of PBM Delayed PBM participants who opted to undergo 12 weeks of PBM treatments after 12 weeks of Usual Care
Change in Arterial Spin Labeled (ASL) Perfusion MRI Measure Baseline total perfusion	0.89 ratio Standard Error 0.11	1.20 ratio Standard Error 0.11	—
Change in Arterial Spin Labeled (ASL) Perfusion MRI Measure Week 12 total perfusion	1.22 ratio Standard Error 0.16	0.91 ratio Standard Error 0.16	—

PRIMARY outcome

Timeframe: change from baseline to 12 weeks

The QOL-AD is a standard quality of life measure that asks parallel questions of affected individuals and their caregivers. Current quality of life is rated as poor (1 point), fair (2 points), good (3 points) or excellent (4 points) in 13 areas: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores around the house, ability to do things for fun, money, and life as a whole. Score range from 0 (worse quality of life) to 52 (best quality of life) This outcome is a change score, derived by subtracting Baseline from Week 12 scores (or Week 12 - Week 24) for Delayed PBM participants who chose to undergo 12 weeks of PBM after 12 weeks of Usual Care). A higher change score = decline in perceived quality of life. A lower or negative change score = improved perceived quality of life.

Outcome measures

Outcome measures
Measure	Immediate PBM Treatment n=4 Participants This arm will receive photobiomodulation (PBM), delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks. Vielight Neuro Gamma: The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment.	Delayed PBM Treatment n=4 Participants This arm will maintain usual activities for 12 weeks. After the week 12 psychometric and MRI assessment, this arm will receive PBM, delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks.	Delayed PBM After 12 Weeks of PBM n=3 Participants Delayed PBM participants who opted to undergo 12 weeks of PBM treatments after 12 weeks of Usual Care
Change in Quality of Life Scale in Alzheimer's Disease (QOL-AD)	1.5 units on QOL-AD score Standard Deviation 3.7	-0.3 units on QOL-AD score Standard Deviation 3.6	3 units on QOL-AD score Standard Deviation 3.5

SECONDARY outcome

Timeframe: change from baseline to 12 weeks

This outcome is a change in the quality of life of the individual with dementia from the caregiver's perspective. Scores range from 52 (best possible perceived quality of life) to 0 (worse possible perceived quality of life). A positive or larger change score = decreased quality of life. A negative or smaller change score = improved quality of life.

Outcome measures

Outcome measures
Measure	Immediate PBM Treatment n=4 Participants This arm will receive photobiomodulation (PBM), delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks. Vielight Neuro Gamma: The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment.	Delayed PBM Treatment n=4 Participants This arm will maintain usual activities for 12 weeks. After the week 12 psychometric and MRI assessment, this arm will receive PBM, delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks.	Delayed PBM After 12 Weeks of PBM n=3 Participants Delayed PBM participants who opted to undergo 12 weeks of PBM treatments after 12 weeks of Usual Care
Change in QOL-AD From the Caregiver's Perspective About the Individual With Dementia	1.8 units on QOL-AD score Standard Deviation 5.0	3.8 units on QOL-AD score Standard Deviation 3.8	-2.3 units on QOL-AD score Standard Deviation 1.5

SECONDARY outcome

Timeframe: change from baseline to 12 weeks

The CBI is a standard measure that includes 24 items and 5 domains. Caregivers are asked to rate how often each statement describes their feelings (never, rarely, sometimes, quite frequently, nearly always). The total score may range from 0 to 96 with higher scores reflecting greater feelings of burden. This outcome is a change score: Baseline CBI score - Week 12 CBI score. A positive (or larger) change score = decrease in caregiver burden. A negative (or smaller) chance score = increase in caregiver burden.

Outcome measures

Outcome measures
Measure	Immediate PBM Treatment n=4 Participants This arm will receive photobiomodulation (PBM), delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks. Vielight Neuro Gamma: The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment.	Delayed PBM Treatment n=4 Participants This arm will maintain usual activities for 12 weeks. After the week 12 psychometric and MRI assessment, this arm will receive PBM, delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks.	Delayed PBM After 12 Weeks of PBM n=3 Participants Delayed PBM participants who opted to undergo 12 weeks of PBM treatments after 12 weeks of Usual Care
Change in Caregiver Burden Inventory (CBI).	12.0 units on the CBI scale Standard Deviation 20.7	-7.8 units on the CBI scale Standard Deviation 9.6	-2.5 units on the CBI scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: change from baseline to 12 weeks

The NPI assesses the frequency and severity of 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and appetite/eating). It is a questionnaire completed by the caregiver about the individual with dementia. The total NPI score ranges from 0 to 144. A higher the total NPI score signifies more numerous, frequent, and/or more severe dementia-related behaviors. This outcome is a change score: Baseline NPI score - Week 12 NPI score. (or Week 12 - Week 24 for Delayed PBM participants who opted to undergo PBM treatments) A positive (or larger) change score = decrease in the number and/or severity of dementia-related behaviors. A negative (or smaller) change score = increase in the number and/or severity of dementia-related behaviors.

Outcome measures

Outcome measures
Measure	Immediate PBM Treatment n=4 Participants This arm will receive photobiomodulation (PBM), delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks. Vielight Neuro Gamma: The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment.	Delayed PBM Treatment n=4 Participants This arm will maintain usual activities for 12 weeks. After the week 12 psychometric and MRI assessment, this arm will receive PBM, delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks.	Delayed PBM After 12 Weeks of PBM n=3 Participants Delayed PBM participants who opted to undergo 12 weeks of PBM treatments after 12 weeks of Usual Care
Change in Neuropsychiatric Inventory (NPI)	17.8 units on CBI scale Standard Deviation 24.4	-2.0 units on CBI scale Standard Deviation 4.5	6.7 units on CBI scale Standard Deviation 4.5

SECONDARY outcome

Timeframe: change from baseline to 12 weeks

The Positive Aspects of Caregiving Scale is a standard measure that asks caregivers to rate their agreement/disagreement with 11 statements about positive aspects of caregiving on a 5-point likert scale (disagree a lot ... agree a lot). Scores can range from 11 (few positive aspects of providing care for someone with dementia) to 55 (many positive aspects of providing care for someone with dementia). This outcome is a change score: Week 12 score - baseline score. A larger (or positive) change score = increase in positive aspects of caregiving. A negative (or smaller) change score = decrease in positive aspects of caregiving.

Outcome measures

Outcome measures
Measure	Immediate PBM Treatment n=4 Participants This arm will receive photobiomodulation (PBM), delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks. Vielight Neuro Gamma: The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment.	Delayed PBM Treatment n=4 Participants This arm will maintain usual activities for 12 weeks. After the week 12 psychometric and MRI assessment, this arm will receive PBM, delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks.	Delayed PBM After 12 Weeks of PBM n=3 Participants Delayed PBM participants who opted to undergo 12 weeks of PBM treatments after 12 weeks of Usual Care
Change in Positive Aspects of Caregiving Scale	0.3 units on Positive Aspects of Caregiving Standard Deviation 3.7	0.0 units on Positive Aspects of Caregiving Standard Deviation 3.2	-0.3 units on Positive Aspects of Caregiving Standard Deviation 5.1

SECONDARY outcome

Timeframe: change from baseline to 12 weeks

The GDS-short form is a 15-item yes/no scale that measures depressive symptoms in older individuals. Scores range from 0-15. Higher scores reflect the presence of more depressive symptoms. A score of 0-5 is normal; a score \> 5 suggests depression; a score ≥ 10 is strong indicator of depression. This outcome is a change score: Baseline GDS score - Week 12 GDS score. In participants randomized Delayed PBM treatment who opt to undergo PBM treatments after 12 weeks of Usual Care, Week 12 GDS score - Week 24 GDS score. A positive (or larger) change score = decrease in depressive symptoms in caregivers. A negative (or smaller) change score = increase in depressive symptoms in caregivers.

Outcome measures

Outcome measures
Measure	Immediate PBM Treatment n=4 Participants This arm will receive photobiomodulation (PBM), delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks. Vielight Neuro Gamma: The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment.	Delayed PBM Treatment n=4 Participants This arm will maintain usual activities for 12 weeks. After the week 12 psychometric and MRI assessment, this arm will receive PBM, delivered with the Vielight Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes (the device automatically shuts itself off after 20 minutes) for 12 weeks.	Delayed PBM After 12 Weeks of PBM n=3 Participants Delayed PBM participants who opted to undergo 12 weeks of PBM treatments after 12 weeks of Usual Care
Change in Geriatric Depression Scale (GDS) - Short Form in the Caregivers	-0.3 units on the Geriatric Depression Scale Standard Deviation 1.0	0.0 units on the Geriatric Depression Scale Standard Deviation 0.8	-0.3 units on the Geriatric Depression Scale Standard Deviation 1

Adverse Events

Immediate PBM Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed PBM Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed PBM Participants Who Underwent PBM Treatment After

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Linda Chao

University of California, San Francisco & San Francisco VA Medical Center

Phone: 14152214810

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place