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The purpose of this study is to evaluate the safety and effectiveness of a novel noninvasive therapy, Nanopulse Laser Therapy (NPLT), to improve recovery following traumatic brain injury (TBI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nano-Pulsed Laser Therapy (NPLT) | Experimental | Participants receive NPLT administered transcranially. |
|
| Standard of Care with Sham NPLT | No Intervention | Participants receive standard care with sham NPLT (laser delivery obstructed but device setup identical). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nano-Pulsed Laser Therapy (NPLT) | Device | Nano-pulsed laser therapy (NPLT) is a novel, noninvasive therapeutic modality that combines near-infrared (NIR) laser light with optoacoustic stimulation. The therapy is delivered using an Optical Parametric Oscillator (OPO) laser system capable of emitting tunable wavelengths within the near-infrared spectrum (690-950 nm). The laser delivers nanosecond-duration pulses (10 nanoseconds) at a repetition rate of 20 Hz, with a maximum pulse energy of up to 150 millijoules per pulse. Energy delivery is precisely calibrated to 0.05 J/cm² per pulse to ensure controlled and consistent exposure. The pulsed NIR energy generates localized optoacoustic effects intended to produce acute physiological responses without tissue ablation or thermal injury. NPLT is administered noninvasively during the acute post-injury period following moderate to severe traumatic brain injury, in accordance with the study protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Nano-pulsed laser therapy (NPLT) Administration Following Moderate to Severe Traumatic Brain Injury | Feasibility will be assessed by the successful administration of NPLT acutely following moderate to severe traumatic brain injury, including protocol adherence and completion of the intervention. | During the hospitalization for up to 6 days |
| Acute Physiological Effects of Nano-Pulsed Laser Therapy (NPLT) | Acute physiological effects will be evaluated by changes in predefined physiological parameters measured before and after NPLT administration during the acute post-injury period. | During the hospitalization for up to 6 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick Karas, MD | Contact | (409)772-1011 | pjkaras@utmb.edu | |
| Maria Micci, PhD | Contact | (409)772-1011 | mmicci@utmb.edu |
| Name | Affiliation | Role |
|---|---|---|
| Patrick Karas, MD | University of Texas Medial Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555-0133 | United States |
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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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This will be a single-blind study. Participants (or their representatives) will be blinded to group assignment. Treating clinicians cannot be blinded due to the nature of the intervention, but they will not be involved in data collection or analysis.
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |