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tPBM for Older Adults with Traumatic Brain Injury

This study is looking into how transcranial photobiomodulation (tPBM) might help older adults (ages 55-85) who have had a traumatic brain injury (TBI). tPBM uses a special helmet that delivers near-infrared light. Researchers want to see if tPBM can improve blood flow in the front part of the brain and help with executive function (skills like planning and problem-solving). You might be able to join if you are between 55 and 85 years old and have a history of a moderate to severe TBI. This study plans to enroll 70 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 70 participants. It compares transcranial photobiomodulator (tPBM) to a sham device that does not produce laser energy.
What's involved
Participants will receive treatment for up to 6 weeks. Measurements of brain blood flow and executive function will be taken at the beginning and end of treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 6 weeks after starting treatment to assess primary endpoints.

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NCT06956404

tPBM in Older Adults With Traumatic Brain Injury

Recruiting
NAAges 55–85InterventionalTreatment
NYU Langone Health
~70 participants
Updated 2026-01-15 on ClinicalTrials.gov
What's tested:Transcranial photobiomodulator (tPBM)Transcranial photobiomodulator (tPBM) in sham mode

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in prefrontal Cerebral Blood Flow (CBF)
Measured over Baseline, end-of-treatment (up to 6 weeks)
+1 more outcome measured

Conditions

Traumatic Brain Injury

Explore related trials

Traumatic Encephalopathy

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Tamara Bushnik, PhD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Tamara Bushnik, PhD
[email protected]
646-565-0468
Email the study team

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What this trial measures

  • Change in prefrontal Cerebral Blood Flow (CBF)Baseline, end-of-treatment (up to 6 weeks)

    CBF will be demonstrated by using arterial spin-labeled (ASL) magnetic resonance imaging (MRI), a method that can reliably quantify absolute CBF level across longer time intervals

  • Change in Executive Function (EF) composite scoresBaseline, end-of-treatment (up to 6 weeks)

    EF composite scores will be derived from five neuropsychological tests (Repeatable Battery for the Assessment of Neuropsychological Status - RBANS, Stroop Color-Word Test, Controlled Oral Word Association Test/FAS, Trail Making Test-A\& B) that assess various aspects of EF.