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 can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of Nano-pulsed laser therapy (NPLT) Administration Following Moderate to Severe Traumatic Brain Injury
Timeframe: During the hospitalization for up to 6 days
2
Acute Physiological Effects of Nano-Pulsed Laser Therapy (NPLT)
Timeframe: During the hospitalization for up to 6 days
Trial details
NCT IDNCT07520383
SponsorThe University of Texas Medical Branch, Galveston