tPBM in Older Adults With Traumatic Brain Injury

NYU Langone Health

Status: Not yet enrolling

Conditions: Traumatic Brain Injury

Treatments: Device: Transcranial photobiomodulator (tPBM); Device: Transcranial photobiomodulator (tPBM) in sham mode

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06956404

24-00956

Details and patient eligibility

About

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)

Enrollment: 70 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Active tPBM

Experimental group

Description:

Subjects complete 18 t-PBM treatments, \~12 min per day, 3 days per week, for 6 weeks. tPBM will be administered via continuous, 808 nm wavelength laser delivery to the forehead at the standard scalp location.

Treatment:

Device: Transcranial photobiomodulator (tPBM)

Sham tPBM

Sham Comparator group

Description:

Subjects complete 18 sham treatments, \~12 min per day, 3 days per week, for 6 weeks. The sham treatment will be administered to the forehead at the standard scalp location.

Treatment:

Device: Transcranial photobiomodulator (tPBM) in sham mode