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Photobiomodulation for Improving Brain Function in Dementia (PBM Dementia) (PBM Dementia)

This study is currently recruiting participants.
Verified May 2017 by Linda Chao, University of California, San Francisco
Sponsor:
ClinicalTrials.gov Identifier:
NCT03160027
First Posted: May 19, 2017
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Linda Chao, University of California, San Francisco
  Purpose
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.

Condition Intervention Phase
Dementia, Alzheimer Type Device: Vielight Neuro Gamma Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Examining the Impact of Photobiomodulation (PBM) on Brain Function in Dementia

Resource links provided by NLM:


Further study details as provided by Linda Chao, University of California, San Francisco:

Primary Outcome Measures:
  • Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) [ Time Frame: Baseline to Week 12 ]
    The ADAS-cog is the most popular cognitive testing instrument used in clinical trials of nootropics. It consists of 11 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD.

  • Change in clock-drawing test [ Time Frame: Baseline to Week 12 ]
    The clock-drawing test is used for screening for cognitive impairment and dementia and as a measure of spatial dysfunction and neglect.

  • Change in Default Mode Network (DMN) functional connectivity, as measured by resting state functional Magnetic Resonance Imaging (rs-fMRI) on a 3 Tesla MRI scanner [ Time Frame: Baseline to Week 12 ]
    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. Evidence has pointed to disruptions in the DMN with people with Alzheimer's disease.

  • Change in cerebral perfusion, as measured by arterial spin labeled (ASL) perfusion MRI on a 3 Tesla MRI scanner [ Time Frame: Baseline to Week 12 ]
    Cerebral perfusion pressure measures blood flow to the brain.

  • Change in Quality of Life Scale in Alzheimer's Disease (QOL-AD) [ Time Frame: Baseline to Week 12 ]
    The QOL-AD is a standard quality of life measure that asks parallel questions of affected individuals and caregivers and was used in our pilot study. 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.


Secondary Outcome Measures:
  • Change in Quality of Life Scale in Alzheimer's Disease (QOL-AD) from the caregiver's perspective about the individual with dementia [ Time Frame: Baseline to Week 12 ]
    The QOL-AD is a standard quality of life measure that asks parallel questions of affected individuals and caregivers and was used in our pilot study. 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.

  • Change in Caregiver Burden Inventory (CBI). [ Time Frame: Baseline to Week 12 ]
    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.

  • Change in Neuropsychiatric Inventory (NPI) from the caregiver's perspective about the individual with dementa [ Time Frame: Baseline to Week 12 ]
    The NPI assesses the frequency, severity and level of distress caused by 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).

  • Change in Positive Aspects of Caregiving Scale [ Time Frame: Baseline to Week 12 ]
    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)

  • Change in Geriatric Depression Scale (GDS) - short form in the caregivers [ Time Frame: Baseline to Week 12 ]
    The GDS-short form is a 15-item yes/no scale that measures depressive symptoms in older individuals.


Estimated Enrollment: 10
Actual Study Start Date: May 15, 2017
Estimated Study Completion Date: April 30, 2018
Estimated Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate PBM treatment
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
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.
No Intervention: Delayed PBM treatment
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.

Detailed Description:

Photobiomodulation (PBM) describes a kind of light therapy that uses red or near-infrared light to stimulate, heal, regenerate, and protect tissue that has either been injured, is degenerating, or else is at risk of dying. Human cadaver studies have shown near-infrared wavelengths can penetrate 40-50 mm through the scalp and skull. Saltmarche et al. (2017) recently reported that 12-weeks of transcranial treatment with a commercially available PBM device (i.e., the Vielight "Neuro ") benefits cognitive function in patients with mild-to-moderately severe dementia. Specifically, Saltmarche et al. reported improvements on the Mini Mental State Examination (MMSE, p< 0.003) and Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog, p< 0.03) in 5 dementia patients after 12-weeks of PBM treatment.

The first aim of this trial is to replicate Saltmarche et al' s findings that the effects of 12-weeks of PBM treatment can improve cognitive function in older adults with dementia. Because the Vielight Neuro device targets nodes of the default mode network (DMN), which is dysregulated in Alzheimer's disease (AD), the second aim of this pilot study is to investigate whether 12 weeks of PBM therapy with the Vielight Neuro device improves DMN connectivity in older adults with dementia. Finally, because there is suggestive evidence that PBM therapy enhances blood flow, the third aim of the trial is to examine whether 12-weeks of PBM therapy improves cerebral blood flow (CBF) in older adults with dementia. The trial will also explore the effects of PBM treatment on quality of life in older adults with dementia and on caregiver burden.

Ten older adults with dementia (i.e., the primary study participants, PP) and their caregivers (CG) will be enrolled in a randomized, wait-list control trial. Five PPs will be randomized to the "immediate" PBM treatment group after the baseline psychometric and MRI assessments. Five PP will be randomized to a "delayed" PBM treatment group that will not receive PBM treatment with the Vielight Neuro device until after the 12 week psychometric and MRI assessments.

Neuroimaging measures will be assessed in all PPs at baseline and week 12. Cognitive function and quality of life will be assessed in all PPs at baseline, weeks 6 and 12. Caregivers (CGs) will be asked to fill out questionnaires Caregivers (CGs) will be asked to fill out questionnaires about caregiver burden, positive aspects of care giving, depressive symptomology, and dementia-related behaviors in the PP at baseline, weeks 6 and 12.

PPs randomized to the "immediate" PBM treatment group will receive PBM with the Vielight Neuro device once a day, every other day (e.g., Mon, Wed, Fri) for 12 weeks. PPs randomized to the "delayed" PBM treatment group will keep doing their usual activities for 12 weeks. After the 12 week psychometric and MRI assessments, PPs randomized to the "delayed" PBM treatment group will receive PBM with the Vielight Neuro device once a day, every other day (e.g., Mon, Wed, Fri) for 12 weeks. PPs randomized to the "delayed" PBM treatment group will undergo additional psychometric assessment at weeks 18 and 24. CGs of PPs randomized to the "delayed" PBM treatment group will be asked to fill out additional questionnaires about caregiver burden, positive aspects of care giving, depressive symptomology, and dementia-related behaviors in the PP at baseline, weeks 18 and 24.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Inclusion criteria for caregivers:

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.

Exclusion Criteria:

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.

Exclusion criteria for caregivers:

major neurological or psychiatric condition terminal illness evidence of cognitive impairment inability to consent to study procedures

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03160027


Contacts
Contact: Linda L Chao, PhD 415-221-4810 ext 24386 linda.chao@ucsf.edu

Locations
United States, California
San Francisco Veterans Affairs Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: Linda L Chao, PhD    415-221-4810 ext 24386    linda.chao@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
  More Information

Additional Information:
Publications:
Responsible Party: Linda Chao, Professor of Radiology & Psychiatry, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03160027     History of Changes
Other Study ID Numbers: 16-21406
First Submitted: May 16, 2017
First Posted: May 19, 2017
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dementia
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases