[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brain-injury-traumatic-mild\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brain-injury-traumatic-mild":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,55,68,97,134,164,187,215],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":36,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100053319","cbt-i-vs-mbti-for-traumatic-brain-injury-tbi-related-insomnia-and-post-traumatic-stress-symptoms-100053319",false,"NCT05663034","CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms","CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for TBI-Related Insomnia and Post-Traumatic Stress Symptoms","Inclusion Criteria:\n\n1. Current or former member of the uniform services\n2. Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI;\n3. Time duration since traumatic brain injury (TBI) injury \\>90 days\n4. Insomnia symptom duration \\>90 days\n5. Endorse insomnia symptoms (Insomnia Severity Index \\[ISI\\] score \\> 10)\n6. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score \\> -2)\n7. \\>18 years of age\n8. Access to and ability and to use computer.\n\nExclusion Criteria:\n\n1. History of neurological diseases other than TBI and not attributable to TBI\n2. Sleep apnea \\[apnea hypopnea index (AHI) \\>15; individuals with mild apnea (AHI \\> 5 and \\\u003C15) will be informed, but allowed to participate\\]. Participants who use a continuous positive airway pressure (CPAP) device for sleep apnea will be eligible for participation if they are below the apnea\u002Fhypopnea cutoff while using CPAP, are adherent to using the device (\\> 4 hours\u002Fnight 21\u002F30 consecutive days) and agree to continue using the device during study participation.\n3. Lastly, people using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.","ALL","18 Years",{"count":19,"type":20},360,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).",[26,27,28,29,30,31,32,33,34,35],"Traumatic Brain Injury","Insomnia","Depression","Post-traumatic Stress","Sleep","Memory Impairment","Cognitive Behavioral Therapy","Concussion, Brain","Head Injury","Brain Injury Traumatic Mild",[26,27,37,28,38,34,39,40,41],"Posttraumatic Stress Symptoms","Concussion","Brain Injury","Cognitive Behavioral Therapy for Insomnia","Mindfulness-based Treatment for Insomnia","RECRUITING","2026-07-10",{"date":45,"type":46},"2026-07-13","ACTUAL",{"date":48,"type":46},"2024-05-10",{"date":50,"type":20},"2027-06",{"name":52,"class":53},"Johns Hopkins University","OTHER",5,{"id":56,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":24,"conditions":59,"keywords":60,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":67,"locationsCount":54},"100490200",{"count":19,"type":20},[23],[26,27,28,29,30,31,32,33,34,35],[26,27,37,28,38,34,39,40,41],"2026-05-26",{"date":63,"type":46},"2026-05-28",{"date":48,"type":46},{"date":66,"type":20},"2026-09",{"name":52,"class":53},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100623473","using-routine-inflammatory-and-metabolic-blood-tests-bedside-included-to-predict-brain-injury-in-children-after-minor-head-trauma-100623473","NCT07397091","Using Routine Inflammatory and Metabolic Blood Tests (Bedside Included) to Predict Brain Injury in Children After Minor Head Trauma","ROUTINE INFLAMMATORY AND METABOLIC BIOMARKERS. Can They Predict a Positive Head CT in Paediatric Minor Traumatic Brain Injury?","paeds_mTBI_Bio","Inclusion Criteria:\n\nPatients aged 0 to 18 years old presenting to the ED with mild traumatic brain injury (with or without cervical injury):\n\n1. Mild TBI will be defined as GCS 14-15 or A (AVPU) upon admission\n2. Patients underwent head CT\n3. Routine blood biomarkers have been collected (complete blood count - CBC, biochemistry and\u002For (arterial) venos blood gases - (A)VBG).\n\nExclusion Criteria:\n\n* Patients with moderate (GCS 13-9 or V) or severe (GCS 8-3 or P,U) head trauma\n* Patients with associated trauma (limb\u002Frib\u002Fpelvic fractures, organ injuries).",{"count":77,"type":20},800,"OBSERVATIONAL","Traumatic brain injury (TBI) poses significant strains on the paediatric population, for which the possible side effects of diagnostic imagistics could induce life-altering conditions. Routine inflammatory and metabolic biomarkers (complete blood count, C reactive protein, glucose) are frequently sampled in the paediatric patients admited within emergency departments, including the low-resource settings. This study aims to retrospectively document whether such routine blood biomarkers could predict a positive head CT scan and subsequently contribute to a prediction score, ment to enable more accurate decision on which minor TBI paediatric patients should be submitted to diagnotic imagistics.",[35],[82,83,84,85],"routine biomarkers","traumatic brain injury","inflammatory","metabolic","NOT_YET_RECRUITING","2026-03-25",{"date":89,"type":46},"2026-03-31",{"date":91,"type":20},"2026-04-20",{"date":93,"type":20},"2026-06-20",{"name":95,"class":53},"Iuliu Hatieganu University of Medicine and Pharmacy",7,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":109,"conditions":110,"keywords":119,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100544564","screening-emotions-in-adolescents-at-the-hospital-for-mtbi-100544564","NCT06370520","Screening Emotions in Adolescents at the Hospital for mTBI","Screening Emotions in Adolescents Receiving Care at the Hospital for mTBI (SEARCH-mTBI)","SEARCH-mTBI","Inclusion Criteria:\n\nChildren 11 to less than 18 years old who meet the Centers for Disease Control and Prevention (CDC) definition of mTBI\\*. In brief, this is defined as a Glasgow Coma Scale (GCS) score of 13 to 15 with:\n\n\\- Head injury (e.g., direct blow or sudden deceleration\u002Facceleration) plus any neurological sign and\u002For symptom such as headache, nausea, history of loss of consciousness, confusion, dizziness, amnesia (not limited to these symptoms\u002Fsigns)\n\nAND\u002FOR\n\n\\- Traumatic intracranial abnormalities on CT or MRI (such as intracranial hemorrhage, skull fracture, or diffuse axonal injury)\n\n\\*mTBI is defined as an acute brain injury resulting in neurological symptoms such as confusion or disorientation, headache, nausea, loss of consciousness, amnesia, seizure, focal signs or symptoms, and\u002For have traumatic intracranial abnormalities on CT or MRI imaging. mTBI patients have GCS scores of 13 to 15. Per CDC precedent, we will use the term mTBI which encompasses other commonly used terms such as \"concussion\" or \"minor head injury\". This will include patients who may have neuroimaging findings of traumatic abnormalities (e.g., intracranial hemorrhage, diffuse axonal injury, skull fractures) which are risk factors for mental health problems; however, neuroimaging is not required for enrollment into the study.\n\nExclusion Criteria:\n\n* Presentation to the ED \\>72 hours post-injury\n* TBI requiring emergent neurosurgical intervention at the time of enrollment\n* Other injuries requiring emergent surgery at the time of enrollment\n* Parent or child unable to accurately complete the study questionnaires due to preexisting functional limitations (e.g., severe developmental delay)\n* Previous known enrollment into the study\n* Patient or parent does not speak English or Spanish","11 Years","17 Years",{"count":108,"type":20},2592,"The goal of this observational study is to develop and validate a clinical tool to predict which adolescents aged 11 to less than 18 years of age with mild traumatic brain injury (mTBI) are at an increased risk for developing significant new or worsening mental health conditions.\n\nThe main aims the study wish to answer are:\n\n* Does the adolescent have new or worsening depression or anxiety defined as a change from their previous medical history using self-reported questionnaires at either one or three months post-injury?\n* Does the adolescent have unmet mental health care needs, defined as not receiving any mental or behavior health care in patients with new or worsening anxiety or depression as defined by the self reported questionnaires?\n\nParticipants will be enrolled after being diagnosed in the emergency department (ED) with an mTBI. During the ED visit, the child's parent\u002Fcaregiver and the adolescent will complete several questionnaires related to mental health which include tools to measure anxiety and depression. Participants will be asked to complete these questionnaires again at 1 month and 3 months post enrollment.",[35,111,112,113,114,115,116,117,118,34],"Brain Injuries","Brain Injuries, Acute","Head Injury With Intracranial Hemorrhage","Head Injury Trauma","Brain Injury Traumatic Focal With Loss of Consciousness","Skull Fractures","Diffuse Axonal Injury","Intracranial Hemorrhages",[120,38,121,111,122,123],"Child","Wounds and Injuries","Head Injuries Trauma","Loss of Consciousness","2025-09-22",{"date":126,"type":46},"2025-09-26",{"date":128,"type":46},"2024-05-22",{"date":130,"type":20},"2028-12",{"name":132,"class":53},"University of California, Davis",6,{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":142,"sex":16,"minAge":143,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":147,"conditions":148,"keywords":149,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":163},"100594889","spotting-and-managing-adult-repeated-traumas-in-the-brain-100594889","NCT07025317","Spotting and Managing Adult Repeated Traumas in the Brain","Developing an Evidence-based Approach to Diagnose and Treat Adults With a History of Concussion","SMARTBRAIN","Inclusion Criteria:\n\n* It will be based on age (60+ years) and history of concussion (with the most recent concussion occurring at least one year prior to the study). Consistent with the literature, the history of concussion will be determined by interviewing participants about their experience with each experience of concussion (e.g. how was the injury sustained (sports injury, vehicle accident, etc.), how long has it been since the injury, did they experience a loss of consciousness during the event, how was their concussion diagnosed, what were their symptoms and when did the symptoms resolve).\n\nThe interview will also gather information on age, sex, gender, education, occupation, and medical history (e.g. mood, medications). These variables will be coded and included in analyses, as appropriate. For example, years of education and years since the most recent concussion can be used as covariates.\n\nExclusion Criteria:\n\n* Include the presence of a diagnosed neurological disorder (e.g. Mild Cognitive Impairment, Alzheimer's disease, Parkinson's disease), history of severe psychiatric disorder (e.g. schizophrenia), or any condition or medication that could affect cognition (e.g. psychotropic, anticholinergic drugs). Exclusion criteria also screen out the presence of any diagnosed visual impairment that could impede NeuroTracker training (i.e. severe colour blindness, monocular vision, blindness), and contraindications for MRI (e.g. metal implants).",true,"60 Years",{"count":145,"type":20},200,[23],"Emerging evidence suggests that concussions (a type of mild traumatic brain injury; mTBIs) may cause chronic neurological disturbances with effects lasting beyond 20 years, changing brain structure and nearly doubling the risks of developing dementia into old age. Yet diagnoses remain notoriously difficult, gender differences are poorly understood, and negligible therapies exist to manage and treat these long-term effects.\n\nThis project proposes using a combination of NeuroTracker (a promising software-based cognitive assessment and intervention for mild TBIs), with the latest MRI techniques and blood-based biomarkers of brain function, to provide unprecedented assessment sensitivity of long-term concussion effects, comparing older male and female adults, with and without a history of concussion. Additionally, NeuroTracker will be used as a therapeutic intervention to improve outcomes in adults with histories of concussion, with the combined assessments measuring efficacy pre-post training.\n\nThis project aims to comprehensively understand the impacts of mild brain traumas into later life, via both physical and functional biomarkers of brain health. It will also validate the value of NeuroTracker as an accessible training intervention for recovering cognitive functions impacted by earlier-life concussions.",[35],[150,151,152,153],"Concussions","mild traumatic brain injury","mild brain traumas","NeuroTracker","2025-07-16",{"date":156,"type":46},"2025-07-20",{"date":158,"type":46},"2024-03-01",{"date":160,"type":20},"2027-02-28",{"name":162,"class":53},"Université de Montréal",3,{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":17,"enrollmentInfo":172,"targetDuration":4,"studyType":21,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":186},"100518869","concussion-health-improvement-program-100518869","NCT06036147","Concussion Health Improvement Program","Optimizing Collaborative Care for Youth With Persistent Post-Concussive Symptoms","CHIP","Inclusion Criteria:\n\n* 11-18 years old\n* Health care provider diagnosed concussion within 1-12 months\n\n  ≥ 3 new onset or worsening post-concussive symptoms (measured with the HBI)\n* Can be located anywhere as study is all completed remotely\n\nExclusion Criteria:\n\n* Active suicidal ideation, diagnosis of psychosis or psychiatric hospitalization within 6 months\n* Spinal cord injury or other severe injury or illness that might impede participation\n* Youth or parent not fluent in Spanish or English\n* Chronic illness or medical conditions that prevent participation in concussion-focused treatment",{"count":173,"type":20},304,[23],"More than 1 million U.S. youth sustain a concussion each year, and up to 30% report persistent post-concussive symptoms (PPCS) lasting 1 month or more. PPCS can interfere with normal adolescent development, resulting in issues with socioemotional dysfunction and even school failure. However, few evidence based treatments are available for youth with PPCS. The investigators conducted extensive work adapting a collaborative care framework for youth with PPCS, combining concussion-focused cognitive behavioral therapy (cf-CBT), parent skills training (PST) and care management (CM) to create a wraparound treatment for youth with PPCS that can be delivered either in-person or virtually. They completed an R01-funded randomized controlled trial with this approach, finding effectiveness for youth with PPCS, with improvements in concussive symptoms and quality of life at one year, and 60% of participants completing the intervention entirely virtually. Of note, this intervention is unique in that two of the components are focused on parents or parents and youth together (PST, CM), and only one of the components (cf-CBT) is solely youth focused. The investigators now propose to optimize and refine this approach, conducting a high efficiency MOST (multiphase optimization strategy) trial to assess the contribution of each of the three components (cf-CBT, PST and CM) to effectiveness, thereby enabling streamlining of the intervention to only include active components. The analysis will be factorial, with three intervention components and two levels of each (present or absent), resulting in 8 treatment pathways. The benefit of the MOST approach is that it combines all youth who receive a component, allowing assessment of all treatment components with only a modest sample size. The study will recruit 374 youth with PPCS, randomizing them to one of 8 treatment groups. Youth and\u002For parents will attend treatment sessions via video conferencing software over three months, and complete surveys regarding primary outcomes (concussive symptoms and health-related quality of life) and secondary outcomes (sleep, pain, mood and parental distress) at 6 weeks, and 3, 6 and 12 months. Potential mediators and moderators will also be assessed to allow for future tailoring and refinement. At the completion of this study, the investigators will have generated a completely optimized and refined intervention for youth with PPCS ready for large scale implementation and dissemination.",[33,35],"2025-03-10",{"date":179,"type":46},"2025-03-13",{"date":181,"type":46},"2023-11-10",{"date":183,"type":20},"2028-01-31",{"name":185,"class":53},"Seattle Children's Hospital",1,{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":194,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":21,"phases":197,"briefSummary":198,"conditions":199,"keywords":200,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":186},"100484516","evaluation-of-the-impact-of-a-dietary-and-nutritional-intervention-on-persistent-post-concussive-symptoms-100484516","NCT05589064","Evaluation of the Impact of a Dietary and Nutritional Intervention on Persistent Post-concussive Symptoms","Evaluation of the Impact of a Dietary and Nutritional Intervention on the Physical, Cognitive, Behavioural and Emotional Symptoms of Patients With Persistent Post-concussive Symptoms","Inclusion Criteria:\n\n* 16 years or older\n* Must be able to understand English or French\n* Have persistent post-concussive symptoms lasting at least 2 weeks but no longer than 6 months\n\nExclusion Criteria:\n\n* \\\u003C16 years old\n* People who are breastfeeding, pregnant or plan to become pregnant in the next 2 months\n* People with neurological disorders (other than concussion) or a history of moderate or severe brain injury\n* People in an acute phase of an inflammatory bowel disease\n* Any physical condition prohibiting a patient from receiving physiotherapy treatments","16 Years",{"count":196,"type":20},120,[23],"Concussions affect thousands of Canadians every year. Although the effects are usually temporary, 10-15% of adults experience persistent symptoms likely to last several weeks or even months. It is suggested that nutritional interventions should be considered in concussion management because nutrition can act on several mechanisms of brain injury. However, to date, no study has assessed the impact of dietary interventions on the recovery of people with persistent post-concussive symptoms.\n\nThis randomized controlled trial aims to determine the impact of a dietary and nutritional intervention on the physical, cognitive, behavioural and emotional symptoms of patients with persistent post-concussive symptoms in New Brunswick, Canada. Patients will be randomized to one of three groups: 1) dietary treatments and nutritional supplements (experimental group A), 2) nutritional supplements (experimental group B), and 3) physiotherapy treatments (control group). Patients in group A will receive four consultations with a dietitian over eight weeks, in addition to conventional physiotherapy treatments. These patients will receive nutritional counselling and omega-3, vitamin D and creatine supplements. Patients in group B will be prescribed the same supplements as those in group A by their doctor and receive physiotherapy treatments. Finally, patients in the control group will only receive physiotherapy treatments. Patient symptoms will be measured using a questionnaire constructed from tools commonly used in practice. This questionnaire will be completed at the first physiotherapy session and 2, 4 and 8 weeks after the start of the intervention.",[35],[201,202,203,204,205],"Dietary intervention","Supplements","Omega-3","Vitamin D","Creatine monohydrate","2024-12-09",{"date":208,"type":46},"2024-12-13",{"date":210,"type":46},"2022-10-01",{"date":212,"type":20},"2025-06",{"name":214,"class":53},"Universite de Moncton",{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":222,"enrollmentInfo":223,"targetDuration":4,"studyType":21,"phases":225,"briefSummary":226,"conditions":227,"keywords":229,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":186},"100527625","brain-health--wellness-classes-for-veterans-with-traumatic-brain-injury-100527625","NCT06150196","Brain Health & Wellness Classes for Veterans With Traumatic Brain Injury","Comparison of Mindfulness-Wellness Class Versus Brain Health Education in Veterans With mTBI","Inclusion criteria:\n\n* 18-75 years old\n* chronic history (\\>6 months) of one or more mTBIs\n* current diagnosis of PTSD\n* at least one self-reported cognitive symptom\n\nExclusion criteria:\n\n* no history of other neurologic disease (e.g., tumor, stroke, dementia, Parkinson's)\n* no history of major brain surgery\n* no history of moderate or severe TBI\n* no active alcohol or drug dependence or abuse within previous 30 days\n* no history of severe psychotic disorder (e.g., schizophrenia)\n* no current suicidal ideation\u002Frisk\n* no clinically severe medical illness requiring treatment","75 Years",{"count":224,"type":20},80,[23],"This study is testing the usefulness of two types of Brain Health \\& Wellness classes for Veterans with a history of concussion to improve mental health.",[35,228],"Post-traumatic Stress Disorder",[230,231,232,233,234,235],"Mindfulness","Mindfulness-based Stress Reduction","TBI","Anxiety","PTSD","Veteran","2023-11-20",{"date":238,"type":46},"2023-11-29",{"date":240,"type":46},"2023-05-01",{"date":242,"type":20},"2026-09-14",{"name":244,"class":53},"East Bay Institute for Research and Education"]