Transcranial light therapy for older adults with traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults aged 55–85 who are one to two years past a moderate non-penetrating traumatic brain injury will receive either active transcranial photobiomodulation (tPBM) or a sham version. Investigators will measure prefrontal cerebral blood flow and executive function before and after the intervention to see if active tPBM produces physiological or cognitive improvements. Key exclusions include dementia, major psychiatric or substance use disorders, significant pre-existing cardiovascular/cerebrovascular disease, and unstable medical conditions to reduce confounding. The single-site study is conducted at NYU Langone Health with support from the U.S. Department of Defense.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Able to give written informed consent and follow study procedures.
2. Age ≥ 55 years and ≤ 85 years.
3. History of non-penetrating TBI of at least moderate severity,

   1. defined by Emergency Department Glasgow Coma Scale (GCS) \< 13,
   2. or post-traumatic amnesia \> 24 hours,
   3. or loss of consciousness \> 30 minutes,
   4. or evidence of trauma-related abnormality on acute neuroimaging.
4. Between 1 and 2 years post injury.

Exclusion Criteria:

1. Delayed loss of consciousness due to expanding lesions
2. Diagnosis of dementia, history of brain tumor, or other serious neurological disorder
3. Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis of alcohol or drug use disorder or history of other major psychiatric illness diagnosed with Mini-International Neuropsychiatric Interview (MINI)
4. History of significant cardiovascular or cerebrovascular pathology before sustaining TBI
5. Unstable medical conditions or medications impacting cognition (e.g., topiramate)
6. Significant skin conditions on the subject's scalp in the area of illumination
7. Large bilateral prefrontal cortex (PFC) lesions (i.e., more than 50% of our middle frontal gyrus region of interest (ROI) in both hemispheres)
8. Claustrophobia or metallic foreign bodies that would preclude MRI
9. Unwilling/unable to comply with study as judged by the Principal Investigator
10. Body mass index \> 40 kg/m2 to fit comfortably in MRI
11. Past intolerance or hypersensitivity to tPBM
12. Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Tamara Bushnik, PhD — NYU Langone Health
• Study coordinator: Tamara Bushnik, PhD
• Email: Tamara.bushnik@nyulangone.org
• Phone: 646-565-0468

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.