[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brain-injury-traumatic-severe\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brain-injury-traumatic-severe":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100553034","cerebral-autoregulation-brain-perfusion-and-neurocognitive-outcomes-after-traumatic-brain-injury-100553034",false,"NCT06480838","Cerebral Autoregulation, Brain Perfusion, and Neurocognitive Outcomes After Traumatic Brain Injury","CAPCOG-TBI","Inclusion Criteria:\n\n* Documented\u002FVerified TBI (ACRM Criteria) (eg, motor vehicle (MV) occupant, MV pedestrian\u002Fcyclist, fall, other non-intentional, violence\u002Fassault)\n* A documented moderate to severe TBI defined as: Glasgow Coma Scale (GCS) \\\u003C 13, or loss of consciousness (LOC) \\> 30 minutes, or posttraumatic amnesia (PTA) \\> 24 hours or intracranial neuroimaging abnormalities\n* Between the age 18 - 80 year-old\n* ≤ 1 week postinjury\n* Acute brain CT for clinical care\n* Admitted to the hospital for TBI\n* Visual acuity\u002Fhearing adequate for testing\n* Fluent in English or Spanish\n* Patient or LAR ability to provide informed consent\n\nExclusion Criteria:\n\n* Age greater or less than the range 18-80 years\n* Significant polytrauma that would interfere with follow-up and outcome assessment\n* Major debilitating baseline mental health disorders (e.g., schizophrenia, bipolar disorder, severe depression with active suicidal thoughts at the time of evaluation) that would interfere with follow-up and the validity of outcome assessment.\n* Major debilitating neurological disease (e.g., stroke, CVA, dementia, tumor) impairing baseline awareness, cognition, or validity of follow-up and outcome assessment.\n* Significant history of pre-existing conditions that would interfere with follow-up and outcome assessment (e.g., active substance abuse, alcoholism, HIV\u002FAIDs, end-stage cancers, learning disabilities, developmental disorders)\n* Patients on psychiatric hold\n* Prisoners or patients in custody\n* Pregnancy in female subjects\n* Low likelihood of follow-up (e.g., participants or family indicating low interest, residence in another state or country, homeless or lack of reliable contacts)\n* Current participant in an interventional trial (e.g., drug, device, behavioral)\n* Penetrating TBI\n* Spinal cord injury with ASIA score of C or worse\n* Contraindications to MRI","ALL","18 Years","80 Years",{"count":20,"type":21},130,"ESTIMATED","OBSERVATIONAL","Cognitive impairment after moderate to severe traumatic brain injury (msTBI) not only significantly affects the quality of life in individuals with msTBI, but also increases the possibility of late-life dementia. The goal of this study is to determine whether acute (\\\u003C 1 week) cerebrovascular injury and its recovery within the first year postinjury measured by cerebral autoregulation and brain perfusion are associated with cognitive outcome at 12 months after msTBI. The results from this study will improve our understanding of cerebrovascular contributions to cognitive decline related to TBI and provide critical data to inform the development of strategies based on vascular mechanisms to improve cognition and prevent neurodegeneration after msTBI.",[25,26,27,28,29],"Traumatic Brain Injury With Loss of Consciousness","Brain Injury Traumatic Severe","Brain Injury Traumatic Moderate","TBI (Traumatic Brain Injury)","TBI","RECRUITING","2026-06-30",{"date":33,"type":34},"2026-07-02","ACTUAL",{"date":36,"type":34},"2023-09-01",{"date":38,"type":21},"2029-05-31",{"name":40,"class":41},"University of Texas Southwestern Medical Center","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100387949","online-memory-intervention-for-individuals-with-traumatic-brain-injury-100387949","NCT04331392","Online Memory Intervention for Individuals with Traumatic Brain Injury","Remotely Delivered Environmental Enrichment Intervention for Traumatic Brain Injury: a Randomized Controlled Trial","Inclusion Criteria:\n\n* acute care diagnosis of m-sTBI\n* PTA of 24 hours or more and\u002For lowest GCS \\\u003C13\n* positive CT or MRI; (4) between 18 to 55 years of age\n* fluency in English; (6) competency to provide informed consent or availability of a legal decision maker\n* basic computer skills (use of internet\u002Femail, mouse and arrow keys)\n* functional use of at least one upper extremity for computer use\n* resident of Greater Toronto Area (to facilitate access to the MRI).\n\nExclusion Criteria:\n\n* neurological disorder other than TBI (e.g., dementia, stroke)\n* diagnosis of a neurodevelopmental disorder\n* TBI sustained before age 18\n* systemic comorbidities (e.g., lupus, diabetes)\n* current diagnosis of aphasia\n* presence of metal inside the body (e.g., surgical clips, pacemaker) leading to ineligibility for an MRI.","55 Years",{"count":51,"type":21},84,"INTERVENTIONAL",[54],"NA","This study will examine the behavioural and neurophysiological efficacy and feasibility of an online spatial navigation intervention for improving memory and brain health in individuals who have sustained moderate-severe traumatic brain injury.",[57,26,27,58],"Brain Injuries, Traumatic","Brain Injury, Chronic",[60,61,62,63,64,65],"Environmental enrichment","spatial navigation","traumatic brain injury","neurorehabilitation","telerehabilitation","hippocampus","2024-11-21",{"date":68,"type":34},"2024-11-25",{"date":70,"type":34},"2018-10-30",{"date":72,"type":21},"2027-02",{"name":74,"class":41},"Toronto Rehabilitation Institute",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":52,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100435054","phase-3-biperiden-trial-for-epilepsy-prevention-100435054","NCT04945213","Biperiden Trial for Epilepsy Prevention","Biperiden for Prevention of Epilepsy in Patients With Traumatic Brain Injury","BIPERIDEN","Inclusion Criteria:\n\n* Given informed consent\n* 18 - 75 years of age\n* GCS between 6 and 12 at hospital admission. GCS between 3 and 5 at hospital admission can be enrolled if patient was sedated at the accident scene with previous GCS between 6 and 15.\n* Moderate or severe acute traumatic brain injury\n* All genders\n* Brain CT scan with signs of of acute intraparenchymal hemorrhage and\u002For contusion\n* Able to receive the first dose of treatment or placebo within 18 hours of brain injury,\n\nExclusion Criteria:\n\n* Previous use of biperiden\n* History of epilepsy (confirmed by patient chart)\n* History of seizures or use of antiepileptic medication\n* Pregnancy\n* Participation in another clinical trial at the time of randomization\n* History of neoplasia, neurodegenerative diseases; history of stroke, cognitive impairment, benign prostatic hyperplasia, atrioventricular block or any other cardiac arrhythmia, or glaucoma megacolon or mechanical obstruction\n* Homeless patient","75 Years",{"count":86,"type":21},312,[88],"PHASE3","One of the most important neurological consequences following Traumatic Brain Injury (TBI) is the development of post traumatic epilepsy (PTE). Nevertheless, there is still no effective therapeutic intervention to reduce the occurrence of PTE. In previous studies with animals models of epilepsy, the biperiden decreased the incidence and intensity of spontaneous epileptic seizures besides delaying their appearance. The aim of this study is the evaluation of biperiden as antiepileptogenic drug to prevent PTE and also the determination of side effects, evaluating its cost-effectiveness in patients with moderate and severe TBI.",[27,26,91],"Post Traumatic Epilepsy",[93,94,95],"Brain Injury","Epilepsy","Biperiden","2024-03-25",{"date":98,"type":34},"2024-03-26",{"date":100,"type":34},"2023-01-10",{"date":102,"type":21},"2026-12-20",{"name":104,"class":41},"Hospital Sirio-Libanes",10]