[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632953":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":37,"responsibleParty":53,"collaborators":18,"id":55,"slug":18,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":18,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":18,"enrollmentInfo":63,"targetDuration":18,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":75,"whyStopped":18,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"The University of Texas Medical Branch, Galveston","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nano-Pulsed Laser Therapy (NPLT)","EXPERIMENTAL","Participants receive NPLT administered transcranially.",[13],"Device: Nano-Pulsed Laser Therapy (NPLT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care with Sham NPLT","NO_INTERVENTION","Participants receive standard care with sham NPLT (laser delivery obstructed but device setup identical).",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"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).\n\nThe 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\u002Fcm² 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.\n\nNPLT is administered noninvasively during the acute post-injury period following moderate to severe traumatic brain injury, in accordance with the study protocol.",[9],[25],{"name":26,"affiliation":27,"role":28},"Patrick Karas, MD","University of Texas Medial Branch","PRINCIPAL_INVESTIGATOR",[30,34],{"name":26,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","(409)772-1011","pjkaras@utmb.edu",{"name":35,"role":31,"phone":32,"phoneExt":18,"email":36},"Maria Micci, PhD","mmicci@utmb.edu",[38],{"facility":39,"status":18,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"University of Texas Medical Branch","Galveston","Texas","77555-0133","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-94.7977,29.30135,{"lat":49,"lon":48},[52],{"name":26,"role":31,"phone":18,"phoneExt":18,"email":18},{"type":54,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100632953",false,"NCT07520383","Nanopulse Laser Therapy","Biomarker Responsiveness of Nanopulse Laser Therapy in Treatment of Traumatic Brain Injury","Inclusion Criteria:\n\n* Adults aged 18 years or older at the time of enrollment\n* Confirmed diagnosis of moderate to severe TBI (clinical assessment and radiographic evidence)\n* Admission to the neurosurgical or neurocritical care service with anticipated need for intracranial monitoring (e.g., microdialysis, ICP probe)\n* Able to initiate treatment within 48 hours of admission\n* Informed consent obtained from patient or legally authorized representative\n\nExclusion Criteria:\n\n* Patients younger than 18 years of age\n* Known or suspected pregnancy (verified via urine pregnancy test for females of childbearing age)\n* Incarcerated individuals or prisoners\n* Patients with pre-existing implanted cranial devices (e.g., deep brain stimulators) that may interfere with NPLT\n* Patients with severe scalp injury or open wounds at intended treatment site\n* Known allergy or hypersensitivity to adhesives or device components","ALL","18 Years",{"count":64,"type":65},30,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","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).",[71],"TBI (Traumatic Brain Injury)",[71,73,74],"Near-Infrared Laser Therapy","Neurometabolic Biomarkers","NOT_YET_RECRUITING","2026-04-02",{"date":78,"type":79},"2026-04-09","ACTUAL",{"date":81,"type":65},"2026-05",{"date":83,"type":65},"2027-05",{"name":5,"class":6},1]