Nanopulse Laser Therapy

ConditionTBI (Traumatic Brain Injury)

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorThe University of Texas Medical Branch, Galveston

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Nano-Pulsed Laser Therapy (NPLT)Experimental treatment 1 intervention

Group B: Standard of Care with Sham NPLTNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

During the hospitalization for up to 6 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Medical Branch, Galveston

Lead sponsor

Source ClinicalTrials.gov

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