Actively Recruiting
tPBM in Older Adults With Traumatic Brain Injury
Led by NYU Langone Health · Updated on 2026-01-15
70
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the effect of transcranial photobiomodulation (tPBM) in older patients with chronic traumatic brain injury (TBI). The study aims to examine the effect of tPBM on prefrontal cerebral blood flow (CBF) and executive function (EF)
CONDITIONS
Official Title
tPBM in Older Adults With Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give written informed consent and follow study procedures
- Age 55 years or older and 85 years or younger
- History of non-penetrating traumatic brain injury of at least moderate severity, defined by one or more of the following: Emergency Department Glasgow Coma Scale below 13, post-traumatic amnesia over 24 hours, loss of consciousness over 30 minutes, or trauma-related abnormality on acute neuroimaging
- Between 1 and 2 years post injury
You will not qualify if you...
- Delayed loss of consciousness due to expanding lesions
- Diagnosis of dementia, history of brain tumor, or other serious neurological disorder
- Diagnosis of alcohol or drug use disorder or history of major psychiatric illness per Mini-International Neuropsychiatric Interview
- History of significant cardiovascular or cerebrovascular disease before TBI
- Unstable medical conditions or use of medications impacting cognition (e.g., topiramate)
- Significant skin conditions on scalp in treatment area
- Large bilateral prefrontal cortex lesions affecting more than 50% of the middle frontal gyrus region in both hemispheres
- Claustrophobia or metallic foreign bodies preventing MRI
- Unable or unwilling to comply with study procedures
- Body mass index over 40 kg/m2
- Past intolerance or hypersensitivity to transcranial photobiomodulation
- Use of light-activated drugs (photodynamic therapy) within 14 days before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
T
Tamara Bushnik, PhD
CONTACT
M
Michelle Smith
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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