TBI (Traumatic Brain Injury)Phase 1NCT07520383
Nanopulse Laser Therapy
A Phase 1 study testing Nano-Pulsed Laser Therapy (NPLT) in people with TBI (Traumatic Brain Injury), run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- What is being tested?
- Nano-Pulsed Laser Therapy (NPLT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555-0133
Patrick Karas, MD
About this study
Official title: Biomarker Responsiveness of Nanopulse Laser Therapy in Treatment of Traumatic Brain Injury
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)
- Being tested
- Nano-Pulsed Laser Therapy (NPLT)
- Keywords
- TBI (Traumatic Brain Injury), Near-Infrared Laser Therapy, Neurometabolic Biomarkers
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Nano-Pulsed Laser Therapy (NPLT) | Experimental | Participants receive NPLT administered transcranially. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the hospitalization for up to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Oct 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Karas, MD, Principal investigator, University of Texas Medial Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520383
- Sponsor's protocol ID
- 25-0155
- Status last verified
- Jul 2026
- First submitted
- 2 Mar 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Responsiveness of Nanopulse Laser Therapy in Treatment of Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT07520383
- Acronym / sponsor ID
- 25-0155
- Conditions
- TBI (Traumatic Brain Injury)
- Keywords
- TBI (Traumatic Brain Injury), Near-Infrared Laser Therapy, Neurometabolic Biomarkers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nano-Pulsed Laser Therapy (NPLT) | Experimental | Device: Nano-Pulsed Laser Therapy (NPLT)Participants receive NPLT administered transcranially. |
| Standard of Care with Sham NPLT | No intervention | –Participants receive standard care with sham NPLT (laser delivery obstructed but device setup identical). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nano-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. | Device | Nano-Pulsed Laser Therapy (NPLT) |
Primary outcome
Feasibility of Nano-pulsed laser therapy (NPLT) Administration Following Moderate to Severe Traumatic Brain Injury
Time frame: During the hospitalization for up to 6 days
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.
Acute Physiological Effects of Nano-Pulsed Laser Therapy (NPLT)
Time frame: During the hospitalization for up to 6 days
Acute physiological effects will be evaluated by changes in predefined physiological parameters measured before and after NPLT administration during the acute post-injury period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Karas, MD principal investigator
University of Texas Medial Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nano-Pulsed Laser Therapy (NPLT) in people with TBI (Traumatic Brain Injury), run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Karas, MD ((409)772-1011, pjkaras@utmb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Nano-pulsed laser therapy (NPLT) Administration Following Moderate to Severe Traumatic Brain Injury (time frame: During the hospitalization for up to 6 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.