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Not yet recruiting NCT07520383

Nanopulse Laser Therapy

Phase I Interventional TBI (Traumatic Brain Injury)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nano-Pulsed Laser Therapy (NPLT).
Who it may be relevant to
Registry conditions: TBI (Traumatic Brain Injury). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Biomarker Responsiveness of Nanopulse Laser Therapy in Treatment of Traumatic Brain Injury

Overview

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

  • Device Nano-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

Primary outcome measures

  • 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]
  • Acute Physiological Effects of Nano-Pulsed Laser Therapy (NPLT) [Time frame: During the hospitalization for up to 6 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Device feasibility

Study locations

United States · 1 center
  • University of Texas Medical Branch — Galveston

Identifiers

NCT: NCT07520383 · 25-0155

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗