Photobiomodulation to Improve Cognition in TBI, With fMRI

Status unconfirmed · Early Phase 1 · Has a placebo group

Conditions studied: Traumatic Brain Injury, Closed Head Injury, Cognitive Dysfunction

In brief

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

Key facts

Study ID: NCT04230577
Run by: Boston VA Research Institute, Inc.
People needed: 20
Starts: 2019-08-07
Expected to finish: 2023-09-30
Last updated by the study team: 2022-02-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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 malingering, with the following exception: If a participant fails Trial 1, but does not fail Trial 2, he/she would not be excluded if he/she also show evidence of poor learning on other NP Screening tests, such as the CVLT. If he/she fails Trial 2, alone, or Trial 1 and Trial 2, then this would exclude the participant from the study.
Self-reported pain questionnaires (VAS Pain Rating and the Short Form McGill Pain Questionnaire) are also administered. Participants may not have a level of pain greater than 7/10 on VAS or 38/50 on the McGill pain questionnaires at the time of screening.
Exclusion for Magnetic Resonance Imaging Only
A BU MRI safety screening form will be reviewed at the time of study screening, as well as at each MRI scan appointment to ensure the participant can safely have an MRI. Participants must tell the investigator about any operations and any metal in his/her body, so it can be decided if it is safe for you to proceed with the scan.
Participants cannot have a MRI scan:
if pregnant.
if he/she has pacemakers, ear implants, shrapnel injuries, or other types of metal or electric device in their body

Where it is running

VA Boston Healthcare System — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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