Traumatic Brain Injury
Conditions
Keywords
TBI
Brief summary
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
DEVICETranscranial 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).
DEVICETranscranial 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).
Sponsors
United States Department of Defense
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in number of treatment emergent adverse events as measured by the Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) | 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. |
Countries
United States
Contacts
Primary ContactTamara Bushnik, PhD
Backup ContactMichelle Smith
Outcome results
None listed