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Not yet recruitingNCT07520383Updated Sep 18, 2026

Nanopulse Laser Therapy

A Phase 1 interventional study of Nano-Pulsed Laser Therapy (NPLT) in TBI (Traumatic Brain Injury), sponsored by The University of Texas Medical Branch, Galveston. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by The University of Texas Medical Branch, Galveston · Phase 1, Interventional, and Device feasibility

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • TBI (Traumatic Brain Injury)

Keywords

  • TBI (Traumatic Brain Injury)
  • Near-Infrared Laser Therapy
  • Neurometabolic Biomarkers
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 1
Primary purpose
Device feasibility
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Nano-Pulsed Laser Therapy (NPLT)

    Participants receive NPLT administered transcranially.

    Device: Nano-Pulsed Laser Therapy (NPLT)

  • No intervention
    Standard of Care with Sham NPLT

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

Interventions

  • DeviceNano-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 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.

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

06

Study locations

1 site
  • University of Texas Medical Branch
    Galveston, Texas 77555-0133, United States
    • Patrick Karas, MD · Contact
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07520383
Lead sponsor
The University of Texas Medical Branch, Galveston
Responsible party
Sponsor
First posted
Apr 9, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Sep 18, 2026

Study contacts

Patrick Karas, MD
Contact
pjkaras@utmb.edu
(409)772-1011
Maria Micci, PhD
Contact
mmicci@utmb.edu
(409)772-1011
Patrick Karas, MD
principal investigator · University of Texas Medial Branch

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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