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NCT Number: NCT07520383

Nanopulse Laser Therapy

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).

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Key information

Conditions

TBI (Traumatic Brain Injury) Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Texas Medical Branch

Galveston, Texas, 77555-0133, United States

Location contact

Patrick Karas, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

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)

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Micci, PhD

CONTACT

[email protected]

(409)772-1011

Patrick Karas, MD

CONTACT

[email protected]

(409)772-1011

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Apr 9, 2026
Registry last updated: Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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