Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2025-12-29
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active tPBM
Subjects complete 18 t-PBM treatments, \~12 min per day, 3 days per week, for 6 weeks. tPBM will be administered via continuous, 808 nm wavelength laser delivery to the forehead at the standard scalp location.
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).
Sham tPBM
Subjects complete 18 sham treatments, \~12 min per day, 3 days per week, for 6 weeks. The sham treatment will be administered to the forehead at the standard scalp location.
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).
Interventions
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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).
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
55 Years
85 Years
ALL
No
Sponsors
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United States Department of Defense
FED
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Tamara Bushnik, PhD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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CDMRP-TP230318
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
24-00956
Identifier Type: -
Identifier Source: org_study_id
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