NCT06956404 · NYU Langone Health
tPBM in Older Adults With Traumatic Brain Injury
What this study is about
The purpose of this study is to evaluate the effect of transcranial photobiomodulation (tPBM) in older patients with chronic traumatic brain injury (TBI).
View original scientific description
The purpose of this study is to evaluate the effect of transcranial photobiomodulation (tPBM) in older patients with chronic traumatic brain injury (TBI).
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).
Primary outcome measures
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New York, New York
Collaborators
United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 15, 2026 · Source of record for eligibility and locations