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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-TP230318 | Other Grant/Funding Number | United States Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tPBM | Experimental | 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. |
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| Sham tPBM | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial photobiomodulator (tPBM) | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in prefrontal Cerebral Blood Flow (CBF) | 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 | Baseline, end-of-treatment (up to 6 weeks) |
| Change in Executive Function (EF) composite scores | 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. | Baseline, end-of-treatment (up to 6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of treatment emergent adverse events as measured by the Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) | 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. |
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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,
Between 1 and 2 years post injury.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tamara Bushnik, PhD | Contact | 646-565-0468 | Tamara.bushnik@nyulangone.org | |
| Michelle Smith | Contact | 646-501-9162 | Michelle.smith@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Tamara Bushnik, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: jkim@med.cuny.edu. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to jkim@med.cuny.edu. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Transcranial photobiomodulator (tPBM) in sham mode | Device | 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). |
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| Baseline, end-of-treatment (up to 6 weeks) |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |