[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mild-traumatic-brain-injury-mtbi\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mild-traumatic-brain-injury-mtbi":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,48,75,109,135,163],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100579100","acceptance-and-commitment-therapy-integrated-vestibular-rehabilitation-active-rct-100579100",false,"NCT06819904","Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT","Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) for mTBI: A Targeted Randomized Controlled Trial","Inclusion Criteria:\n\n* 18-49 years of age\n* Normal\u002Fcorrected vision\n* Diagnosed with mTBI per military clinical practice guidelines (CPGs) that occurred over 8 days prior to consent as determined by a multi-domain assessment performed by a licensed healthcare professional.\n* mTBI-related symptoms and\u002For impairments in at least one or more areas, including vestibular (dizziness, imbalance), psychological health (anxiety, depression, stress), cognitive (memory problems), headache\u002Fmigraine, ocular, or sleep. as determined by self-report.\n\nExclusion Criteria:\n\n* History of vestibular disorder (e.g., benign paroxysmal positional vertigo, unilateral or bilateral vestibular hypofunction) as determined by patient self-report.\n* History of neurological disorder (e.g., epilepsy, multiple sclerosis) as determined by self-report.\n* Cervical spine injury or dysfunction (i.e., limited range of motion; ROM) as determined by self-report.\n* Previous moderate to severe TBI as determined by self-report.\n* \\\u003C 8 days following current mTBI as determined by self-report.\n* Currently pregnant as determined by self-report.","ALL","18 Years","49 Years",{"count":20,"type":21},250,"ESTIMATED","INTERVENTIONAL",[24],"NA","The primary objective of this multi-site randomized clinical trial (RCT) is to compare Acceptance and Commitment Therapy Integrated Rehabilitation (ACT) with usual care rehabilitation (CONTROL) in 250 individuals with mTBI-related symptoms attributable to mild traumatic brain injury (mTBI) treated at one of two sites (1) the University of Pittsburgh Medical Center, or (2) the Intrepid Spirit Center, Carl R. Darnall Army Medical Center, Fort Hood, Texas. Both interventions will be delivered weekly over 4 weeks. Assessments will be administered prior to the start of treatment (Baseline) and at 4-weeks, 3- and 6-months following the completion of treatment.",[27,28,29],"Concussion, Mild","Mild Traumatic Brain Injury (mTBI)","Psychological Health",[31,32,33,34],"concussion","mTBI","psychological health","treatment","RECRUITING","2026-06-25",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":39},"2025-02-27",{"date":43,"type":21},"2027-08",{"name":45,"class":46},"University of Pittsburgh","OTHER",2,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100637110","examining-the-efficacy-of-the-man-therapy-platform-in-reducing-problematic-anger-among-military-service-members-with-and-without-a-tbi-history-100637110","NCT07604701","Examining the Efficacy of the Man Therapy Platform in Reducing Problematic Anger Among Military Service Members With and Without a TBI History","Examining the Efficacy of the Man Therapy Platform in Reducing Problematic Anger Among Military Service Members With and Without a TBI History: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Military service member\n* Identify as male\n* Aged 18+ years\n* Positive problematic anger screen (DAR-3 \\>8)\n* Ability to read, write, and speak English\n\nExclusion Criteria:\n\n* Active psychosis or acute mania necessitating clinical intervention\n* Acute thoughts of self- or other-harm necessitating imminent clinical intervention (e.g., hospitalization)\n* Unable to provide informed consent","MALE",{"count":57,"type":21},226,[24],"The goal of this randomized controlled trial is to determine if an interactive digital solution, Man Therapy, reduces indices of problematic anger in male military service members who screen positive for problematic anger.\n\nThe man questions this study aims to answer are:\n\n* Does Man Therapy reduce indices of problematic anger?\n* Does Man Therapy reduce psychosocial correlates of anger?\n\nResearchers will also examine if the effects of those aims differ based on a participant's history of a mild TBI, the mechanism of a primary mild TBI, and\u002For the number of mild TBIs.\n\nResearchers will compare Man Therapy to a waitlist control. This will help determine if Man Therapy works better than no treatment.\n\nParticipants will:\n\n* Complete a baseline survey\n* Be randomized to intervention or waitlist control\n* If randomized to intervention, participants will receive the intervention and complete a survey immediately after the intervention and at 1-, and 3-months following the intervention\n* If randomized to waitlist control, participants complete surveys at 1-, and 3-months and have the opportunity to complete the intervention following the 3-month survey",[28,61,62],"Traumatic Brain Injury","Anger",[61,62],"NOT_YET_RECRUITING","2026-05-26",{"date":67,"type":39},"2026-05-29",{"date":69,"type":21},"2026-09-01",{"date":71,"type":21},"2028-12-01",{"name":73,"class":46},"University of Colorado, Denver",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":95,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":74},"100640010","mobile-dual-task-brain-and-balance-intervention-for-concussion-recovery-100640010","NCT07599475","Mobile Dual-Task Brain and Balance Intervention for Concussion Recovery","Boosting Brain and Balance: A Mobile Dual-Task Intervention for Athletes With Concussion and Mild Traumatic Brain Injury (mTBI)","Inclusion Criteria:\n\n* Adults aged 18 to 40 years\n* Self-reported history of sports-related concussion (SRC) or mild traumatic brain injury (mTBI) within the past 3 to 12 months\n* Meets criteria for mTBI based on a standardized screening method (e.g., Ohio State University TBI Identification Method)\n* Able to safely participate in light physical activity (e.g., walking) and simple cognitive tasks based on self-report and observational screening by the research team\n* Able to read and understand English (if applicable for study materials)\n* Able to provide informed consent\n* Has access to and is able to use a smartphone or mobile device to complete daily app-based activities\n\nExclusion Criteria:\n\n* Age younger than 18 years or older than 40 years\n* History of moderate or severe traumatic brain injury\n* Concussion or mTBI occurring less than 3 months or more than 12 months prior to enrollment\n* Self-reported active medical disease or history of neurological or psychiatric conditions unrelated to concussion\n* Self-reported other medical conditions that would limit safe participation in light physical activity (e.g., walking or balance tasks)\n* Currently on prescribed medications that may significantly affect cognitive function, balance, neurological function, or safe participation in light physical activity\n* Inability to use a smartphone or mobile device required for study participation\n* Inability to read or understand English (as study materials and the mobile application are currently available only in English)","40 Years",{"count":84,"type":21},20,[24],"This research study examines recovery after a sports-related concussion or mild head injury. Many athletes experience lingering problems with thinking, balance, and mood months after a concussion.\n\nWe are testing a new home-based program called BraW-Day™ (Brain \\& Walk Exercise Every Day). This 14-day program uses a mobile app on your smartphone and combines simple brain exercises (like counting backwards) with walking exercises. The idea is that doing these tasks together may help your brain and body recover more effectively.\n\nWhat You'll Do:\n\n* Two in-person visits at UNLV (baseline and after 14 days) for assessments\n* Daily 15-minute exercises at home using the BraW-Day app\n* Provide a small saliva sample for biomarker testing\n* Complete brief questionnaires about your symptoms and health\n\nPotential Benefits:\n\nYou may experience improvements in thinking, balance, or mood. Even if you don't benefit directly, your participation will help researchers understand how to better support athletes recovering from concussion.\n\nWho Can Join:\n\n* Ages 18-40\n* Had a sports-related concussion or mild head injury within the past 3-12 months\n* Have a smartphone and can safely do light walking and simple tasks\n\nThis study is registered at ClinicalTrials.gov and approved by the UNLV Institutional Review Board to protect your safety and rights.",[28,88,89,90,91,92,93,94],"Sports-related Concussion","Heart Rate Variability (HRV)","Walking","Oculomotor","Saliva","Exosomal microRNA","Cognitive Function",[96,97,98,99],"dual-task","mild traumatic brain injury (mTBI)","sports-related concussion","BraW-Day","2026-05-14",{"date":102,"type":39},"2026-05-20",{"date":104,"type":21},"2026-05-15",{"date":106,"type":21},"2027-04-30",{"name":108,"class":46},"Hyunhwa Lee",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":131,"leadSponsor":133,"locationsCount":47},"100635195","postural-motor-activation-deficits-after-mtbi-translating-laboratory-findings-to-clinical-care-100635195","NCT07549529","Postural Motor Activation Deficits After mTBI; Translating Laboratory Findings to Clinical Care","Inclusion Criteria:\n\n* Diagnosed mTBI (concussion)\n* 18-60 years of age\n* More than 2 weeks from the date of the most recent mTBI\n* Less than 6 months from the most recent mTBI\n* Persisting symptoms from the mTBI\n\nExclusion Criteria:\n\n* Injury, medical, or neurological illness that could explain balance issues\n* Moderate to severe substance abuse in the past month\n* Display behavior that would interfere with safety during data collection\n* Significant pain during the study period (\\> 7\u002F10)\n* Pregnancy\n* Persistent use of medications that cause balance impairment during the study\n* Active in physical therapy services for mTBI symptoms","60 Years",{"count":117,"type":21},80,[24],"This work will address an important gap in physical therapy rehabilitation after concussion. Physical therapy usually focuses on how the brain processes sensory information such as inner ear and vision for balance rehabilitation, but our recent research shows that people with imbalance more often have a problem with how they can respond to imbalance (i.e., motor activation). While there are complex laboratory tools to test motor activation for balance, these tests are not practical for the clinic. The goal of this study is to create both an exercise intervention focused on motor activation after concussion and simple, but objective and instrumented (wearable sensors), clinical measures of motor activation. Objectives: This research study has three aims. 1) The investigators and study team will develop an exercise program to improve the problems with how one's body responds to imbalance (i.e., improve motor activation) after a concussion. The study team will use a Community Based Participatory Research (CBPR) approach by collaborating with a team of people with a broad range of experience related to concussion. The study team will form a Community Advisory Board (CAB) that will include patients who have had a concussion, healthcare professionals with expertise in concussion, and healthcare administrators. The CAB will contain people working in the military and civilians. 2) The investigators will compare our new motor-focused physical therapy intervention to the standard sensory focused balance intervention. The goal is to determine which intervention program is more effective in treating balance problems after a concussion. The investigators hypothesize that the motor-focused program will help patients more compared to the sensory program. 3) The investigators and study team will create and test several balance tests that can be used in the clinical without expensive research equipment to our standard research-based motor activation tests. This aim will allow the study team to determine if the clinical tests perform as well as the research-grade tests. To make the test useful to clinicians, the study team will use simpler technology like smart-phone applications, wearable sensors, and virtual reality goggles that are both affordable and practical for healthcare providers.",[28,121],"Concussion, Mild Traumatic Brain Injury",[32,31,123,124,125,126],"motor activation","reaction time","physical therapy","vestibular rehabilitation","2026-04-23",{"date":129,"type":39},"2026-04-29",{"date":38,"type":21},{"date":132,"type":21},"2029-08-30",{"name":134,"class":46},"Oregon Health and Science University",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":149,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":47},"100581813","symptom-targeted-approach-to-rehabilitation-for-concussion-star-c-100581813","NCT06855186","Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C)","Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C): RCT of In-person vs Telehealth vs Wait List Control","STAR-C","Inclusion Criteria:\n\n* mTBI defined per the VA\u002FDoD Clinical Practice Guideline for the Management of Concussion-Mild Traumatic Brain Injury sustained in any context (deployment related or non-deployment-related) and at any time longer than 3 months previously.\n* a score of 2, 3, or 4 on any of the four Cognitive items on the NSI, to include participants who have cognitive complaints.\n* a score on the Word Reading Subtest of the Wide Range Achievement Test of a sixth-grade reading level or higher, to ensure participants can read study materials.\n\nExclusion Criteria:\n\n* History of a moderate, severe, or penetrating TBI as defined by DoD\u002FVA guidelines.\n* Lifetime diagnosis of schizophrenia or other psychotic\u002Fthought disorder.\n* Current participation in intensive behavioral health treatment (≥3 appointments \u002Fencounters per week) for any psychiatric or substance use disorder.\n* Current participation in other treatments that target cognition within the last two weeks (i.e., healthcare provider-prescribed cognitive rehabilitation in a group or individual format of any time duration or involving digital\u002Fgame-based format of more than 4 hours per week).\n* History of a neurological disease affecting cognitive function, other than mild TBI, such as multiple sclerosis, stroke, brain tumor, or Parkinson Disease.\n* Current, active suicidal or homicidal ideation.\n* Daily use of narcotic pain medications.\n* Lack of access to technology or internet\u002Fcell phone service that supports telemedicine.\n* Current participation in other therapy targeting cognition (Note: This is not the same as Cognitive Behavioral Therapy\u002FCBT which addresses psychological issues and may continue during participation in this research project).","64 Years",{"count":145,"type":21},222,[24],"Purpose: Investigators propose a three-arm RCT across two military treatment facilities:1) in-person STAR-C, 2) telehealth STAR-C, and 3) no treatment control. Outcomes will be assessed immediately and at one- and three-months post treatment.\n\nHypothesis\u002FObjectives: STAR-C, delivered in-person and via telehealth, will be effective in decreasing everyday cognitive complaints among patients with a history of mTBI. Effectiveness will be moderated by patient characteristics. Stakeholder feedback will yield a process map for broad implementation of STAR-C in varied clinical environments.",[28],[31,150,151,152,153],"brain injury","cognitive rehabilitation","military","adults","2026-01-07",{"date":156,"type":39},"2026-01-08",{"date":158,"type":39},"2025-09-18",{"date":160,"type":21},"2028-08-31",{"name":162,"class":46},"Henry M. Jackson Foundation for the Advancement of Military Medicine",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":171,"targetDuration":173,"studyType":174,"phases":4,"briefSummary":175,"conditions":176,"keywords":177,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":74},"100616890","implementation-of-biomarker-based-care-for-mtbi---impacts-braini-study-100616890","NCT07311486","Implementation of Biomarker-Based Care for mTBI - IMPACTS-BRAINI Study","BLOOD BIOMARKERS TO IMPROVE MANAGEMENT OF MILD TRAUMATIC BRAIN INJURY IMPLIMENTACIÓN STUDY","IMPACTS-BRAINI","Inclusion Criteria:\n\n* -All adult patients suffering mild TBI:( Defined by at least criterion a) and d) and one or more of the other criteria)\n\n  1. The presence of a plausible traumatic mechanism observed\u002For related by the patient´s recount of the injury event.\n  2. Presence of one or more clinical signs attributable to brain injury: Loss of consciousness immediately following injury, alteration of mental status immediately following the injury, posttraumatic amnesia or any neurological abnormality.\n  3. At least two acute symptoms related to the injury: feeling confused or disoriented, headache, nausea, vomiting, dizziness, vision problems, memory problems, emotional lability or irritability.\n  4. a GCS between 15 and 13, at least 30 minutes after injury.\n* Blood sample obtained ≤12 h after injury and ideally before any imaging prescription.\n\nExclusion Criteria:\n\n* · GCS 3-12 on admission\n\n  * Age Below 18 years\n  * Time of injury unknown\n  * Time to injury exceeding 12 hours\n  * Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous, intracranial hematoma)\n  * Penetrating head trauma\n  * Patient with mechanical ventilation from the trauma scene or prehospital management\n  * Venipuncture not feasible",{"count":172,"type":21},1000,"2 Weeks","OBSERVATIONAL","This study aims to evaluate the real-world applicability and clinical added value of a new management pathway for patients presenting to the emergency department (ER) with mild traumatic brain injury (mTBI). The pathway includes the use of the VIDAS® TBI in vitro diagnostic assay, which measures the blood biomarkers GFAP and UCH-L1 within 12 hours of injury to determine whether a CT scan is necessary.\n\nThe study seeks to answer two primary questions:\n\n1. Safety and effectiveness: Whether the VIDAS® TBI test can safely and accurately rule out the need for head CT in mTBI patients in routine emergency care.\n2. Clinical and operational impact: Whether incorporating this test reduces the number of CT scans performed and shortens ER length of stay for patients with mild TBI.\n\nTo assess these outcomes, researchers will compare patient management using the new biomarker-based pathway to a historical cohort of mTBI patients who were managed without the biomarker test.",[28],[178,179,180,181],"Biomarker","GFAP","UCH-L1","Implementation","2025-12-21",{"date":184,"type":39},"2025-12-31",{"date":186,"type":39},"2025-07-15",{"date":188,"type":21},"2026-05-01",{"name":190,"class":46},"Hospital Universitario 12 de Octubre"]