RecruitingNot ApplicableNCT06956404

tPBM in Older Adults With Traumatic Brain Injury

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

Sponsor

NYU Langone Health

Enrollment

70 participants

Start Date

Dec 29, 2025

Study Type

INTERVENTIONAL

Conditions

Traumatic Brain Injury

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

Min Age: 55 YearsMax Age: 85 Years

Inclusion Criteria8

Able to give written informed consent and follow study procedures.
Age ≥ 55 years and ≤ 85 years.
History of non-penetrating TBI of at least moderate severity,
defined by Emergency Department Glasgow Coma Scale (GCS) < 13,
or post-traumatic amnesia > 24 hours,
or loss of consciousness > 30 minutes,
or evidence of trauma-related abnormality on acute neuroimaging.
Between 1 and 2 years post injury.

Exclusion Criteria12

Delayed loss of consciousness due to expanding lesions
Diagnosis of dementia, history of brain tumor, or other serious neurological disorder
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)
History of significant cardiovascular or cerebrovascular pathology before sustaining TBI
Unstable medical conditions or medications impacting cognition (e.g., topiramate)
Significant skin conditions on the subject's scalp in the area of illumination
Large bilateral prefrontal cortex (PFC) lesions (i.e., more than 50% of our middle frontal gyrus region of interest (ROI) in both hemispheres)
Claustrophobia or metallic foreign bodies that would preclude MRI
Unwilling/unable to comply with study as judged by the Principal Investigator
Body mass index > 40 kg/m2 to fit comfortably in MRI
Past intolerance or hypersensitivity to tPBM
Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment

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Interventions

DEVICETranscranial 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).

DEVICETranscranial 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).