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NCT06956404NARecruiting

tPBM in Older Adults With Traumatic Brain Injury

NYU Langone Health

Start Date

12/29/2025

Completion Date

7/1/2028

Summary

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)

Eligibility Criteria

Age Range: 55 years to 85 years

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

Interventions

DEVICE

Transcranial photobiomodulator (tPBM)

DEVICE

Transcranial photobiomodulator (tPBM) in sham mode

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Conditions

Traumatic Brain Injury

Locations

NYU Langone Health

New York, New York 10016

United States