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Not Yet Recruiting
NCT07520383
Nanopulse Laser Therapy
Conditions: TBI (Traumatic Brain Injury)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 30
Sponsor: The University of Texas Medical Branch, Galveston
Location: University of Texas Medical Branch Galveston Texas
Summary
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).
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18 years or older at the time of enrollment
* Confirmed diagnosis of moderate to severe TBI (clinical assessment and radiographic evidence)
* Admission to the neurosurgical or neurocritical care service with anticipated need for intracranial monitoring (e.g., microdialysis, ICP probe)
* Able to initiate treatment within 48 hours of admission
* Informed consent obtained from patient or legally authorized representative
Exclusion Criteria:
* Patients younger than 18 years of age
* Known or suspected pregnancy (verified via urine pregnancy test for females of childbearing age)
* Incarcerated individuals or prisoners
* Patients with pre-existing implanted cranial devices (e.g., deep brain stimulators) that may interfere with NPLT
* Patients with severe scalp injury or open wounds at intended treatment site
* Known allergy or hypersensitivity to adhesives or device components
Source: ClinicalTrials.gov (NCT07520383). StuddyBuddy aggregates publicly available trial information.