Nanopulse Laser Therapy

Phase 1Not Yet RecruitingNCT07520383

The University of Texas Medical Branch, Galveston30 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

SINGLE

Enrollment

Conditions

TBI (Traumatic Brain Injury)

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Texas Medical Branch

Galveston, Texas, United States

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

Central Contacts

Patrick Karas, MD

CONTACT

(409)772-1011 pjkaras@utmb.edu

Maria Micci, PhD

CONTACT

(409)772-1011 mmicci@utmb.edu

Data from ClinicalTrials.gov

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