Recruiting

Transcranial Photobiomodulation

Sponsor:

NYU Langone Health

Code:

NCT06956404

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcranial photobiomodulator (tPBM)

Transcranial photobiomodulator (tPBM) in sham mode

Study Details

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)

Conditions

Traumatic Brain Injury

Study ID

NCT06956404

Start date

Dec 29, 2025

Status verified date

Apr, 2025

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active tPBM

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.

sham comparator: Sham tPBM

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.

Interventions

Transcranial photobiomodulator (tPBM)

The tPBM-2.0 device consists of a therapeutic laser console (that produces laser energy as NIR), and an optical delivery system consisting of a flexible, double-sheathed optical fiber connected to a custom helmet (cap). tPBM will be administered via continuous, 808 nm wavelength laser delivery to the forehead at the standard scalp location \~12 minutes per day, 3 days per week, for 6 weeks (18 total sessions).

Transcranial photobiomodulator (tPBM) in sham mode

The tPBM-2.0 device consists of a therapeutic laser console (which will be in sham mode, which does not produce laser energy), and an optical delivery system consisting of a flexible, double-sheathed optical fiber connected to a custom helmet (cap).

Primary outcome measure

  • Change in prefrontal Cerebral Blood Flow (CBF) [ Time Frame: Baseline, end-of-treatment (up to 6 weeks) ]
  • Change in Executive Function (EF) composite scores [ Time Frame: Baseline, end-of-treatment (up to 6 weeks) ]

Central Contacts and Locations

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Jan 15, 2026

Last verified

Apr, 2025

Keywords

  • TBI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-01-15.