Nanopulse Laser Therapy

Part of paid clinical trials in Galveston, Texas.

Sponsor
The University of Texas Medical Branch, Galveston
Study ID
NCT07520383
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • TBI (Traumatic Brain Injury)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Nano-Pulsed Laser Therapy (NPLT)
    Participants receive NPLT administered transcranially.
  • No Intervention: Standard of Care with Sham NPLT
    Participants receive standard care with sham NPLT (laser delivery obstructed but device setup identical).

Primary Outcome Measure

Feasibility of Nano-pulsed laser therapy (NPLT) Administration Following Moderate to Severe Traumatic Brain Injury [ Time Frame: During the hospitalization for up to 6 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Medical BranchGalvestonTexas77555-0133
Patrick Karas, MD

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University of Texas Medical Branch· Galveston, TX

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