Photobiomodulation for Improving Brain Function in Dementia (PBM Dementia)

NCT03160027 | Completed Results FDA Device

• 1 other identifier: 16-21406
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A recent study (Saltmarche et al., 21017) examined the effects of photobiomodulation (PBM), a kind of light therapy that uses red or near-infrared light to heal and protect tissue that has either been injured, is degenerating, or else is at risk of dying, in 5 older adults with dementia. After 12 weeks of PBM treatments, delivered with a commercially available, wearable device, the patients with mild to moderately severe dementia showed improvements on the Mini-mental State Exam (MMSE, p\<0.003) and Alzheimer's Disease Assessment Scale-cognitive, ADAS-cog, p\<0.03). The caregivers, who kept daily journals of their experiences during the 12 weeks of PBM treatment, reported better sleep, fewer angry outbursts, decreased anxiety and wandering in their loved-ones with dementia. The goals of this trial are to: (1) replicate this finding in a larger group of individuals with dementia and (2) to examine the underling brain mechanisms behind the changes in cognitive function.

Conditions

Dementia, Alzheimer Type

Outcome Measures

Primary Outcomes (5)

• Change in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog)

  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.

  change from baseline to 12 weeks

• Change in Clock-drawing Test

  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.

  change from baseline to 12 weeks

• Change in Default Mode Network (DMN) Functional Connectivity

  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".

  change from baseline to 12 weeks

• Change in Arterial Spin Labeled (ASL) Perfusion MRI Measure

  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 .

  change from baseline to 12 weeks

• Change in Quality of Life Scale in Alzheimer's Disease (QOL-AD)

  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.

  change from baseline to 12 weeks

Secondary Outcomes (5)

• Change in QOL-AD From the Caregiver's Perspective About the Individual With Dementia

  change from baseline to 12 weeks

• Change in Caregiver Burden Inventory (CBI).

  change from baseline to 12 weeks

• Change in Neuropsychiatric Inventory (NPI)

  change from baseline to 12 weeks

• Change in Positive Aspects of Caregiving Scale

  change from baseline to 12 weeks

• Change in Geriatric Depression Scale (GDS) - Short Form in the Caregivers

  change from baseline to 12 weeks

Study Arms (2)

Immediate PBM treatment

EXPERIMENTAL

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.

Device: Vielight Neuro Gamma

Delayed PBM treatment

NO INTERVENTION

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.

Interventions

Vielight Neuro Gamma DEVICE

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For primary study participants (i.e., individuals with dementia):
• age \> 50 years a diagnosis of dementia (preferably AD) by their neurologist English language fluency, legally authorized representative consent no contraindications for MRI MMSE \> 11
• current provision of care to primary participant with dementia ability to answer questions about the primary participant's behaviors, quality of life, and their own level of stress.

You may not qualify if:

• For primary study participants (i.e., individuals with dementia):
• lack of assent to study procedures contraindications for MRI (i.e., pacemakers, metal implants, claustrophobia) terminal illness (i.e., life expectancy \< 1 year) started dementia medication (i.e., cholinesterase inhibitor or memantine) in the past 3 months or planning to start new dementia medication current participation in another research study that could potentially confound current study (e.g., medication or behavioral intervention) MMSE \< 11.
• major neurological or psychiatric condition terminal illness evidence of cognitive impairment inability to consent to study procedures

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

(1) small sample size, (2) absence of a sham-control group, (3) the patients' diagnoses of dementia were not independently confirmed by a neurologist, and (4) adherence to the PBM treatment protocol was solely monitored in home treatment diaries.

Results Point of Contact

• Title: Dr. Linda Chao
• Organization: University of California, San Francisco & San Francisco VA Medical Center

linda.chao@ucsf.edu

14152214810

Study Officials

• Linda L Chao, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants randomized to the "Immediate PBM treatment" group will receive 12 weeks of PBM, delivered with the Vielight Neuro device, for 12 weeks, once every other day (e.g., Mon, Wed, Fri), undergo behavioral assessments at baseline, weeks 6 and 12, and undergo 3 Tesla MRI at baseline and week 12. Participants randomized to the "Delayed PBM treatment" group will maintain their usual activities for 12 weeks, undergo behavioral assessments at baseline, weeks 6 and 12, and undergo 3 Tesla MRI at baseline and week 12. After the week 12 behavioral and MRI assessments, participants in this group will receive 12 weeks of PBM, delivered with the Vielight Neuro device, for 12 weeks, once every other day (e.g., Mon, Wed, Fri), undergo behavioral assessments at weeks 18 and 24.

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 19, 2017
• Study Start: May 15, 2017
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: October 6, 2020
• Results First Posted: August 20, 2019

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)