Recruiting NCT06956404
tPBM in Older Adults With Traumatic Brain Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial photobiomodulator (tPBM), Transcranial photobiomodulator (tPBM) in sham mode.
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury. Basic parameters: 55 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Transcranial Photobiomodulation in Older Adults With Traumatic Brain Injury: Effects on Cerebral Blood Flow and Cognition
Overview
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)
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)]
- Change in Executive Function (EF) composite scores [Time frame: Baseline, end-of-treatment (up to 6 weeks)]
Secondary outcome measures (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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT06956404 · 24-00956 · CDMRP-TP230318