TBI (Traumatic Brain Injury)
Conditions
Keywords
TBI (Traumatic Brain Injury), Near-Infrared Laser Therapy, Neurometabolic Biomarkers
Brief 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).
Interventions
DEVICENano-Pulsed Laser Therapy (NPLT)
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.
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Subject)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Nano-pulsed laser therapy (NPLT) Administration Following Moderate to Severe Traumatic Brain Injury | During the hospitalization for up to 6 days | 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. |
| Acute Physiological Effects of Nano-Pulsed Laser Therapy (NPLT) | During the hospitalization for up to 6 days | Acute physiological effects will be evaluated by changes in predefined physiological parameters measured before and after NPLT administration during the acute post-injury period. |
Countries
United States
Contacts
CONTACTPatrick Karas, MD
CONTACTMaria Micci, PhD
PRINCIPAL_INVESTIGATORPatrick Karas, MD
University of Texas Medial Branch
Outcome results
None listed