Nano-Pulsed Laser Therapy for Traumatic Brain Injury

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PK
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?

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).

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?

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

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+