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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Transcranial photobiomodulator (tPBM) and a medical device called Transcranial photobiomodulator (tPBM) in sham mode for people with traumatic brain injury. The study is currently recruiting participants at 1 location. People eligible for this study include aged 55 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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).