Photobiomodulation to Improve Cognition in TBI, With fMRI (NCT04230577) | Clinical Trial Compass
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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
CVLT-II, Long Delay Free Recall 1
Timeframe: Change from Pre-Treatment Baseline to 1-Week after Series 1
2
CVLT-II, Long Delay Free Recall 2
Timeframe: Change from Pre-Treatment Baseline to 1-Month after Series 1
3
CVLT-II, Long Delay Free Recall 3
Timeframe: Change from 1-Week to 1-Month after Series 1
4
CVLT-II, Long Delay Free Recall 4
Timeframe: Change from Pre-Treatment Baseline to 1-Week after Series 2