tPBM in Older Adults With Traumatic Brain Injury

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Traumatic Brain Injury

In brief

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)

Key facts

Study ID

NCT06956404

Run by

NYU Langone Health

People needed

70

Starts

2025-12-29

Expected to finish

2028-07-01

Last updated by the study team

2026-01-15

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to give written informed consent and follow study procedures.
• Age ≥ 55 years and ≤ 85 years.
• History of non-penetrating TBI of at least moderate severity,
• defined by Emergency Department Glasgow Coma Scale (GCS) < 13,
• or post-traumatic amnesia > 24 hours,
• or loss of consciousness > 30 minutes,
• or evidence of trauma-related abnormality on acute neuroimaging.
• Between 1 and 2 years post injury.

You may not qualify if…

• Delayed loss of consciousness due to expanding lesions
• Diagnosis of dementia, history of brain tumor, or other serious neurological disorder
• 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)
• History of significant cardiovascular or cerebrovascular pathology before sustaining TBI
• Unstable medical conditions or medications impacting cognition (e.g., topiramate)
• Significant skin conditions on the subject's scalp in the area of illumination
• Large bilateral prefrontal cortex (PFC) lesions (i.e., more than 50% of our middle frontal gyrus region of interest (ROI) in both hemispheres)
• Claustrophobia or metallic foreign bodies that would preclude MRI
• Unwilling/unable to comply with study as judged by the Principal Investigator
• Body mass index > 40 kg/m2 to fit comfortably in MRI
• Past intolerance or hypersensitivity to tPBM
• Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment

Where it is running

• NYU Langone Health — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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