tPBM in Older Adults With Traumatic Brain Injury

NANot yet recruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

May 31, 2025

Primary Completion Date

July 31, 2028

Study Completion Date

July 31, 2028

Conditions
Traumatic Brain Injury
Interventions
DEVICE

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).

DEVICE

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).

Trial Locations (1)

10016

NYU Langone Health, New York

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

NYU Langone Health

OTHER

NCT06956404 - tPBM in Older Adults With Traumatic Brain Injury | Biotech Hunter | Biotech Hunter