Clinical trial NCT06956404: tPBM in Older Adults With Traumatic Brain Injury
Official title: Transcranial Photobiomodulation in Older Adults With Traumatic Brain Injury: Effects on Cerebral Blood Flow and Cognition
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: TBI
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2025-05-04
Enrollment: 70
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 on prefrontal cerebral blood flow (CBF) and executive function (EF)


Eligibility criteria: 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

Primary outcomes:
measure: Change in prefrontal Cerebral Blood Flow (CBF)
timeFrame: Baseline, end-of-treatment (up to 6 weeks)
measure: Change in Executive Function (EF) composite scores
timeFrame: Baseline, end-of-treatment (up to 6 weeks)
Secondary outcomes:
measure: Change in number of treatment emergent adverse events as measured by the Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI)
timeFrame: Baseline, end-of-treatment (up to 6 weeks)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Tamara Bushnik, PhD
role: PRINCIPAL_INVESTIGATOR
References: