UnknownEarly Phase 1

Photobiomodulation to Improve Cognition in TBI, With fMRI

United States20 participantsStarted 2019-08-07

Plain-language summary

The purpose of this small, research study is to examine effectiveness of an at-home application of an experimental intervention, on thinking and memory in mild-moderate, closed-head, traumatic brain injury cases. The experimental intervention is light-emitting diode (LED) therapy, which is applied to the scalp and through the nose using a head frame device. Participants are expected to complete two, 5-week series of LED treatments, at home, 3 times a week. There will be a 1-month period between the two series. Each home treatment is 20 minutes. Participants will be trained to use the head frame device, in-office. The head frame device falls within the FDA category General Wellness, low-risk devices, and no medical claims are made. A two-hour paper and pencil testing (4 visits) and a one-hour MRI (3 visits) will be administered before and after each treatment series. Participants may be in the study for about 4 months. This study is supported by Vielight, Inc., Hayward, CA/ Toronto, Canada

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18-65 years old * Must have had one (or more) closed-head, traumatic brain injuries * Loss of consciousness 24 hours or less; or no loss of consciousness/ A period of altered mental status (post-traumatic amnesia)/mental confusion for 24 hours or less * Must be able to come to VA Boston Healthcare System, Jamaica Plain Campus for testing visits and Boston University Center for Biomedical Imaging, Boston University School of Medicine for MRI scans Must meet the following Screening requirements: * Participants must score at least 2 SD below normal on at least 1 of the NP tests; or 1 SD below on at least 2 of these NP tests administer at Entry testing: Trail Making Test A \& B; Controlled Oral Word Association Test (COWAT/FAS); California Verbal Learning Test II; DKEFS Color-Word Interference Test (Stroop). Exclusion Criteria: * Diagnosis of a neurological disease such amyotrophic lateral sclerosis (ALS), Parkinson's, Alzheimer's disease * History of craniotomy or craniectomy * A current life-threatening disease such as cancer * Disease requiring organ transplant * A severe mental disorder such as schizophrenia, bipolar disorder (not associated with clinically diagnosed PTSD) * Current substance abuse or active treatment; within the last 6 months * The Test of Memory Malingering is administered at screening; Participants must not have scores that indicate evidence of malingering, a score of less than 45 on either Part 1 or 2 would show evidence of mali…

What they're measuring

CVLT-II, Long Delay Free Recall 1

Timeframe: Change from Pre-Treatment Baseline to 1-Week after Series 1

CVLT-II, Long Delay Free Recall 2

Timeframe: Change from Pre-Treatment Baseline to 1-Month after Series 1

CVLT-II, Long Delay Free Recall 3

Timeframe: Change from 1-Week to 1-Month after Series 1

CVLT-II, Long Delay Free Recall 4

Timeframe: Change from Pre-Treatment Baseline to 1-Week after Series 2

Trial details

NCT IDNCT04230577

SponsorBoston VA Research Institute, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-31

Contact for this trial

Paula I Martin, PhD

857-364-4029 Paula.Martin@va.gov

View on ClinicalTrials.gov More Traumatic Brain Injury trials