Nanopulse Laser Therapy

NCT07520383 | Not Yet Recruiting Phase 1 DMC FDA Device

• 1 other identifier: 25-0155
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

TBI (Traumatic Brain Injury)

Keywords

TBI (Traumatic Brain Injury); Near-Infrared Laser Therapy; Neurometabolic Biomarkers

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  During the hospitalization for up to 6 days

Study Arms (2)

Nano-Pulsed Laser Therapy (NPLT)

EXPERIMENTAL

Participants receive NPLT administered transcranially.

Device: Nano-Pulsed Laser Therapy (NPLT)

Standard of Care with Sham NPLT

NO INTERVENTION

Participants receive standard care with sham NPLT (laser delivery obstructed but device setup identical).

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.

Nano-Pulsed Laser Therapy (NPLT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555-0133, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Patrick Karas, MD

  University of Texas Medial Branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Karas, MD

CONTACT

(409)772-1011; pjkaras@utmb.edu

Maria Micci, PhD

CONTACT

(409)772-1011; mmicci@utmb.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This will be a single-blind study. Participants (or their representatives) will be blinded to group assignment. Treating clinicians cannot be blinded due to the nature of the intervention, but they will not be involved in data collection or analysis.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: April 9, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)