Status:
NOT_YET_RECRUITING
tPBM in Older Adults With Traumatic Brain Injury
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
United States Department of Defense
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
55-85 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06956404
Start Date
May 1 2025
End Date
July 1 2028
Last Update
May 4 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016