tPBM in Older Adults With Traumatic Brain Injury

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06956404
Status
Recruiting
Apply to this trial

Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
55 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial photobiomodulator (tPBM) — DEVICE
    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 — DEVICE
    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).

Study Details

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)

Key Dates

Start date
Dec 29, 2025
Status verified
Apr 2025
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

Find similar trials in New York, NY

By research site
NYU Langone Health· New York, NY

Related Studies