tPBM in Older Adults With Traumatic Brain Injury

Not Applicable

Not yet recruiting

• Conditions: Traumatic Brain Injury

• Registration Number: NCT06956404
• Lead Sponsor: NYU Langone Health

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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-24
• Study First Submitted QC: 2025-04-24
• Last Update Submitted: 2025-04-24
• Study Start: 2025-05
• Study First Posted: 2025-05-04
• Last Update Posted: 2025-05-04
• Primary Completion: 2028-07
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in prefrontal Cerebral Blood Flow (CBF)	Baseline, end-of-treatment (up to 6 weeks)	CBF will be demonstrated by using arterial spin-labeled (ASL) magnetic resonance imaging (MRI), a method that can reliably quantify absolute CBF level across longer time intervals
Change in Executive Function (EF) composite scores	Baseline, end-of-treatment (up to 6 weeks)	EF composite scores will be derived from five neuropsychological tests (Repeatable Battery for the Assessment of Neuropsychological Status - RBANS, Stroop Color-Word Test, Controlled Oral Word Association Test/FAS, Trail Making Test-A\& B) that assess various aspects of EF.

Secondary Outcome Measures

Name	Time	Method
Change in number of treatment emergent adverse events as measured by the Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI)	Baseline, end-of-treatment (up to 6 weeks)	The SAFTEE-SI is a commonly used instrument originally developed by National Institute of Mental Health (NIMH) and adapted into a self-report instrument. The scale examines in a systematic fashion all possible treatment-emergent side effects and probes specific adverse symptoms, including suicidal thoughts and behaviors, and self-injurious behavior.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States