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RECRUITINGINTERVENTIONAL

tPBM in Older Adults With Traumatic Brain Injury

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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)

Who May Be Eligible (Plain English)

Who May Qualify: 1. Able to give written willing to sign a consent form and follow study procedures. 2. Age ≥ 55 years and ≤ 85 years. 3. History of non-penetrating TBI of at least moderate severity, 1. defined by Emergency Department Glasgow Coma Scale (GCS) \< 13, 2. or post-traumatic amnesia \> 24 hours, 3. or loss of consciousness \> 30 minutes, 4. or evidence of trauma-related abnormality on acute neuroimaging. 4. Between 1 and 2 years post injury. Who Should NOT Join This Trial: 1. Delayed loss of consciousness due to expanding lesions 2. Diagnosis of dementia, history of brain tumor, or other serious neurological disorder 3. 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) 4. History of significant cardiovascular or cerebrovascular pathology before sustaining TBI 5. Unstable medical conditions or medications impacting cognition (e.g., topiramate) 6. Significant skin conditions on the subject's scalp in the area of illumination 7. Large bilateral prefrontal cortex (PFC) lesions (i.e., more than 50% of our middle frontal gyrus region of interest (ROI) in both hemispheres) 8. Claustrophobia or metallic foreign bodies that would preclude MRI 9. Unwilling/unable to comply with study as judged by the Principal Investigator 10. Body mass index \> 40 kg/m2 to fit comfortably in MRI 11. Past intolerance or hypersensitivity to tPBM 12. Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Able to give written informed consent and follow study procedures. 2. Age ≥ 55 years and ≤ 85 years. 3. History of non-penetrating TBI of at least moderate severity, 1. defined by Emergency Department Glasgow Coma Scale (GCS) \< 13, 2. or post-traumatic amnesia \> 24 hours, 3. or loss of consciousness \> 30 minutes, 4. or evidence of trauma-related abnormality on acute neuroimaging. 4. Between 1 and 2 years post injury. Exclusion Criteria: 1. Delayed loss of consciousness due to expanding lesions 2. Diagnosis of dementia, history of brain tumor, or other serious neurological disorder 3. 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) 4. History of significant cardiovascular or cerebrovascular pathology before sustaining TBI 5. Unstable medical conditions or medications impacting cognition (e.g., topiramate) 6. Significant skin conditions on the subject's scalp in the area of illumination 7. Large bilateral prefrontal cortex (PFC) lesions (i.e., more than 50% of our middle frontal gyrus region of interest (ROI) in both hemispheres) 8. Claustrophobia or metallic foreign bodies that would preclude MRI 9. Unwilling/unable to comply with study as judged by the Principal Investigator 10. Body mass index \> 40 kg/m2 to fit comfortably in MRI 11. Past intolerance or hypersensitivity to tPBM 12. Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment

Treatments Being Tested

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).

Locations (1)

NYU Langone Health
New York, New York, United States