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NCT Number: NCT06956404

tPBM in Older Adults With Traumatic Brain Injury

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)

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

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).

Other names: Transcranial PhotoBioModulation-1000 (tPBM-2.0)

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).

Other names: Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Primary outcomes

  1. Change in prefrontal Cerebral Blood Flow (CBF)

    Time frame: 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

  2. Change in Executive Function (EF) composite scores

    Time frame: Baseline, 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.

Secondary outcomes

  1. Change in number of treatment emergent adverse events as measured by the Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI)

    Time frame: Baseline, end-of-treatment (up to 6 weeks)

    The SAFTEE-SI is a commonly used instrument originally developed by National Institute of Mental Health (NIMH) and adapted into a self-report instrument. The scale examines in a systematic fashion all possible treatment-emergent side effects and probes specific adverse symptoms, including suicidal thoughts and behaviors, and self-injurious behavior.

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Smith

CONTACT

[email protected]

646-501-9162

Tamara Bushnik, PhD

CONTACT

[email protected]

646-565-0468

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 4, 2025
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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