Nano-Pulsed Laser Therapy for Traumatic Brain Injury

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Overseen ByPatrick Karas, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: The University of Texas Medical Branch, Galveston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new, noninvasive treatment called Nanopulse Laser Therapy (NPLT) to determine its safety and effectiveness in improving recovery from traumatic brain injuries (TBI). Participants will receive either the NPLT treatment or standard care with a sham version of the therapy. The trial seeks adults who recently experienced a moderate to severe TBI and can begin treatment within 48 hours of admission to a neurosurgical or critical care unit. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Nanopulse Laser Therapy is safe for traumatic brain injury?

Research has shown that Nano-Pulsed Laser Therapy (NPLT) could be safe for treating traumatic brain injury (TBI). In studies with rats, NPLT reduced brain swelling, a common issue after brain injury, suggesting it works without harming brain tissue.

The treatment uses light pulses to target specific areas, and researchers have determined the safest and most effective dose. This careful approach helps minimize any possible negative effects.

In this Phase 1 trial, researchers primarily assess the treatment's safety for humans. This phase is crucial for identifying any side effects or adverse reactions. While NPLT is still under human testing, positive results from animal studies support its potential safety.12345

Why do researchers think this study treatment might be promising for TBI?

Unlike the standard treatments for traumatic brain injury, which typically involve medications and rehabilitation therapies, Nano-Pulsed Laser Therapy (NPLT) is administered transcranially and uses precise laser pulses to target brain tissue. This innovative approach is believed to promote cellular repair and reduce inflammation directly within the brain, which standard therapies don't address as directly. Researchers are excited about NPLT because it offers a non-invasive alternative that could potentially accelerate recovery and improve outcomes for individuals with traumatic brain injuries.

What evidence suggests that Nanopulse Laser Therapy might be an effective treatment for traumatic brain injury?

This trial will compare Nano-Pulsed Laser Therapy (NPLT) with standard care for traumatic brain injuries. Research suggests that NPLT might help treat these injuries by reducing brain swelling. In animal studies, NPLT improved brain function and decreased brain cell death after an injury. Previous findings indicate that NPLT can aid brain recovery by enhancing thinking skills and minimizing damage. While these results are promising, they are primarily based on studies with rats. More research is needed to confirm these effects in humans.12345

Who Is on the Research Team?

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Patrick Karas, MD

Principal Investigator

University of Texas Medial Branch

Are You a Good Fit for This Trial?

This trial is for adults 18 or older with a confirmed moderate to severe traumatic brain injury, admitted to neurocritical care and needing brain monitoring. Participants must start treatment within 48 hours of admission. People under 18, pregnant, prisoners, those with certain cranial implants or scalp injuries can't join.

Inclusion Criteria

Informed consent obtained from patient or legally authorized representative
I am 18 years old or older.
Admission to the neurosurgical or neurocritical care service with anticipated need for intracranial monitoring (e.g., microdialysis, ICP probe)
See 2 more

Exclusion Criteria

I am younger than 18 years old.
Known or suspected pregnancy (verified via urine pregnancy test for females of childbearing age)
Incarcerated individuals or prisoners
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Nano-Pulsed Laser Therapy (NPLT) administered transcranially during hospitalization

Up to 6 days
Daily visits during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Nanopulse Laser Therapy

Trial Overview

The study tests Nano-Pulsed Laser Therapy (NPLT), a new noninvasive laser treatment aimed at improving recovery after traumatic brain injury. The main goal is to see if NPLT is safe and effective when used soon after the injury.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Nano-Pulsed Laser Therapy (NPLT)Experimental Treatment1 Intervention
Group II: Standard of Care with Sham NPLTActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials
263
Recruited
55,400+

Citations

Nano-pulsed laser therapy (NPLT) system for ...

Our most recent data show that NPLT significantly reduces neuroinflammation even when applied to rats months after brain injury, suggesting that ...

Nano-Pulsed Laser Therapy Is Neuroprotective in a Rat Model ...

Our data demonstrate a neuroprotective effect of NPLT and prompt further studies aimed to develop NPLT as a therapeutic intervention after traumatic brain ...

Study Details | 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 ...

Nano-pulsed Laser Therapy (NPLT) System for ...

Nano-pulsed Laser Therapy (NPLT) System for Therapy of Traumatic Brain Injury Patients ... NPLT improves neurocognitive outcomes, reduces neuroinflammation ...

Nano-pulsed laser therapy (NPLT) system for ...

... traumatic brain injury (TBI) NPLT improves neurocognitive outcomes, reduces neuroinflammation and neurodegeneration, and normalizes neurogenesis. In this ...