Transcranial light therapy for older adults with traumatic brain injury

Transcranial Photobiomodulation in Older Adults With Traumatic Brain Injury: Effects on Cerebral Blood Flow and Cognition

This trial will test whether near-infrared light applied to the forehead can increase prefrontal blood flow and improve thinking skills in people aged 55–85 who had a moderate non-penetrating TBI one to two years ago.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 55 Years to 85 Years
• Sex: All
• Sponsor: NYU Langone Health (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT06956404 on ClinicalTrials.gov

What this trial studies

Adults aged 55–85 who are one to two years past a moderate non-penetrating traumatic brain injury will receive either active transcranial photobiomodulation (tPBM) or a sham version. Investigators will measure prefrontal cerebral blood flow and executive function before and after the intervention to see if active tPBM produces physiological or cognitive improvements. Key exclusions include dementia, major psychiatric or substance use disorders, significant pre-existing cardiovascular/cerebrovascular disease, and unstable medical conditions to reduce confounding. The single-site study is conducted at NYU Langone Health with support from the U.S. Department of Defense.

Who should consider this trial

Good fit: Ideal candidates are adults 55–85 years old who are one to two years after a moderate non-penetrating TBI, can give written informed consent, and have no major neurological, psychiatric, or unstable medical conditions.

Not a fit: Patients with dementia, a history of brain tumor or serious neurological disease, recent expanding brain lesions, major substance use or psychiatric disorders, significant pre-existing cardiovascular/cerebrovascular disease, or those outside the 1–2 year post-injury window are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, tPBM could provide a noninvasive way to boost prefrontal blood flow and improve executive function in older adults with chronic moderate TBI.

How similar studies have performed: Small prior trials of transcranial photobiomodulation in TBI and age-related cognitive decline have shown mixed but promising signals for improved blood flow and cognition, so the approach has preliminary support but is not yet proven.

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

Where this trial is running

New York, New York

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

Study contacts

• Principal investigator: Tamara Bushnik, PhD — NYU Langone Health
• Study coordinator: Tamara Bushnik, PhD

Conditions Traumatic Brain Injury; TBI