[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brain-injuries-traumatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brain-injuries-traumatic":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,51,77,99,129,151,175,199,241,268,302,324,362,385,406,437,460],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100641311","socio-cultural-level-health-literacy-and-parental-ct-demand-in-paediatric-minor-head-trauma-100641311",false,"NCT07655310","Socio-Cultural Level, Health Literacy, and Parental CT Demand in Paediatric Minor Head Trauma","The Relationship Between Family Socio-Cultural Level, Health Literacy, and Parental Demand for Computed Tomography in PECARN-Stratified Children Presenting With Minor Head Trauma: A Single-Centre Prospective Observational Cohort Study","Inclusion Criteria:\n\n1. Age less than 18 years at time of emergency department presentation\n2. Presenting complaint of head trauma sustained within the preceding 24 hours\n3. Classified as minor head trauma at triage, defined as a Glasgow Coma Scale (GCS) score of 14 or 15 at initial assessment\n4. Accompanied by a parent or legal guardian with capacity to provide written informed consent\n\nExclusion Criteria:\n\n1. GCS score 13 or less at presentation (moderate or severe head injury)\n2. Transfer from another medical facility\n3. Head trauma sustained more than 24 hours before emergency department presentation\n4. Known coagulopathy, anticoagulant therapy, or bleeding disorder\n5. Ventriculoperitoneal shunt in situ\n6. Previous intracranial neurosurgery\n7. Pre-existing neurological disorder affecting GCS interpretation (e.g., cerebral palsy, developmental delay)\n8. Clinical suspicion of abusive head trauma (non-accidental injury) identified by the treating physician\n9. Concurrent multi-system trauma\n10. No accompanying parent or guardian available for consent and socio-cultural assessment","ALL","17 Years",{"count":19,"type":20},200,"ESTIMATED","OBSERVATIONAL","Minor head trauma is one of the most frequent reasons for paediatric emergency department visits worldwide. The PECARN (Paediatric Emergency Care Applied Research Network) clinical decision rule stratifies children with minor head trauma into low-, intermediate-, and high-risk categories for clinically important traumatic brain injury (ciTBI) and provides evidence-based guidance on computed tomography (CT) ordering. Despite its high diagnostic accuracy, real-world CT utilisation frequently diverges from PECARN recommendations. Non-clinical family-level factors - including socio-cultural characteristics and health literacy - may drive part of this divergence, particularly through their influence on whether families explicitly request CT imaging.\n\nThis prospective observational cohort study will enrol 200 children with minor head trauma presenting to the emergency department of SBU Bursa Yuksek Ihtisas EAH, Bursa, Turkey. The primary aim is to determine whether family socio-cultural level (composite index incorporating education, occupation, income, and housing; scored 0-10) and health literacy (Newest Vital Sign-Turkish, NVS-TR) independently predict parental demand for CT imaging. Secondary aims include determining whether parental CT demand and family socio-cultural characteristics predict CT ordering by the treating physician, describing PECARN algorithm adherence patterns in this setting, and examining parental health-seeking behaviour at 7-day telephone follow-up.",[24,25,26],"Craniocerebral Trauma","Brain Injuries, Traumatic","Head Injuries, Closed",[28,29,30,31,32,33,34,35,36,37],"PECARN","paediatric head trauma","minor head trauma","computed tomography","health literacy","socio-cultural level","clinical decision rule","parental CT demand","emergency medicine","NVS-TR","RECRUITING","2026-06-17",{"date":41,"type":42},"2026-06-22","ACTUAL",{"date":44,"type":42},"2024-04-10",{"date":46,"type":20},"2027-08",{"name":48,"class":49},"Bursa Yuksek Ihtisas Training and Research Hospital","OTHER_GOV",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":50},"100642573","scale-up-evaluation-trial-of-the-diabetes-prevention-program-to-improve-obesity-and-cardiometabolic-health-after-traumatic-brain-injury-100642573","NCT07648901","Scale-Up Evaluation Trial of the Diabetes Prevention Program to Improve Obesity and Cardiometabolic Health After Traumatic Brain Injury","GLB Scale-Up","Inclusion Criteria:\n\n* 18-80 years of age\n\n  -≥6 months post-TBI\n* Moderate to severe TBI at time of injury\n* BMI ≥25 kg\u002Fm2\n* Able to communicate in English\n\nExclusion Criteria:\n\n* Contraindications to physical activity\n* Low cognitive function\n* Residing in hospital, acute rehab, SNF\n* Self-Reported Pregnancy\n* Pre-existing diagnosis of an eating disorder\n* Former DPP-GLB Participants (less than 6months since participation ended)","18 Years","80 Years",{"count":61,"type":20},70,"The Investigators have proposed targeted efforts to address the feasibility, effectiveness, fidelity, and evaluation of the GLB-TBI Evidence Based Intervention (EBI) in a real world setting at a CDC-recognized site",[64,25,65],"Traumatic Brain Injury","Brain Injury, Chronic","NOT_YET_RECRUITING","2026-06-15",{"date":69,"type":42},"2026-06-16",{"date":71,"type":20},"2026-08-15",{"date":73,"type":20},"2028-08-30",{"name":75,"class":76},"Baylor Research Institute","OTHER",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100504437","automated-robotic-tcd-in-traumatic-brain-injury-100504437","NCT05848297","Automated Robotic TCD in Traumatic Brain Injury","Automated Robotic TCD in Traumatic Brain Injury (ART-TBI)","ART-TBI","Inclusion Criteria:\n\n* Adults ≥18\n* Blunt TBI with Glasgow Coma Score (GCS) ≤8\n* Injury within 72 hours\n* Adequate TCD windows\n* Ability to obtain informed consent from a Legally Authorized Representative (LAR)\n\nExclusion Criteria:\n\n* Catastrophic brain injury with grim prognosis (e.g.: GCS 3 with bilateral mid-position pupil)\n* C- spine fracture with evidence of spinal cord injury\n* Severe skull or scalp injury precluding device placement\n* Planned decompressive hemicraniectomy\n* Continuous fever for \\>6 hours at the time of enrollment (despite treatment)\n* Lack of TCD window",{"count":86,"type":20},30,"This study's objective is to determine the safety, feasibility and efficacy of prolonged automated robotic TCD monitoring in critically ill patients with severe TBI across multiple clinical sites with varying levels of TCD availability and experience",[25],"2026-06-01",{"date":91,"type":42},"2026-06-03",{"date":93,"type":42},"2025-05-20",{"date":95,"type":20},"2027-05",{"name":97,"class":76},"Virginia Commonwealth University",3,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":50},"100638745","light-therapy-to-improve-sleep-in-tbi-sleep-active-biomarkers-and-glymphatic-function-100638745","NCT07601841","Light Therapy to Improve Sleep in TBI: Sleep-active Biomarkers and Glymphatic Function","Light Therapy to Improve Sleep in Veterans With TBI: Sleep-active Biomarkers and Glymphatic Function","GLIMPSE-LION","All subjects must:\n\n1. Male and female; any race; 18-89 years of age.\n2. Be English speaking.\\*\n3. Be accessible via phone.\n4. Be non-decisionally impaired. Determined by assessing the subject's ability to verbalize their understanding of the protocol back to us during the informed consent process.\n5. Not have a history of macular degeneration.\n6. Not have a history of bipolar disorder.\n7. Not be currently using a lightbox or a negative ion generator.\n8. Not be a shift worker.\n9. Have a documented history of TBI via the Head Trauma Events Characteristics (HTEC) or OHIO conducted in accordance with VA\u002FDoD Clinical Practice Guidelines.88\n10. Present with self-reported sleep-wake disturbances.\n11. Remain clinically stable for current pharmacologic treatment related to depression\u002Fanxiety, sleep, and pain.\n12. MRI specific compatibility requirements:\n\n    * No pacemaker, wires, defribrillator or implanted heart valves\n    * No history of head surgery requiring aneurysm clips\n    * No history of other orthopedic or general surgery requiring the implantation of ferrous pins, joints, electric devices\u002Fpumps, or other foreign metal objects\n    * History of eye exposure to metal (unprotected welding\u002Fmetalworking\u002Fshrapnel) is allowable provided the participant screens negative for metal in the eyes on an orbital x-ray or is able to provide clinical documentation of having screened negative.\n    * No history of non-removable hearing aids, middle\u002Finner ear prosthesis, or dentures\n    * No history of claustrophobia; if unsure participant will be pre-screened in our mock scanner\n    * Not currently pregnant, breastfeeding, or have an implanted IUD. Participants who are unsure of their pregnancy status will be administered an hCG urine pregnancy test the day of their scan.\n    * Able to lay flat on their back comfortably without a thick pillow for an extended period of time.\n    * Shoulder width does not exceed width for safety fitting in the MRI bore.\n\n      * This study is limited to English-speaking participants because all assessments, interventions, and consent materials are currently validated and approved only in English. Expanding to other languages would require translation and psychometric validation, which are beyond the scope and budget of this study. This limitation is acknowledged and will be addressed in future research as resources permit. Finally, the study team is only fluent in English, making it infeasible to accurately consent or interact with non-English speakers without interpreting services which again is outside of the scope of this projects budget and timeline. Proceeding without formal translation services would risk miscommunication in informed consent, data collection, or participant support and thus protects participants informed consent and participant understanding.","89 Years",{"count":109,"type":20},300,"INTERVENTIONAL",[112],"NA","This is a clinical trial designed to examine how improved sleep through morning bright light therapy is improving downstream key physiologic processes related to brain health, i.e., mitochondrial function, systemic inflammation, and glymphatic function. All proposed methodology is already approved in other IRB applications.",[115,116,117,118,25,119],"Sleep","Phototherapy","Glymphatic System","Mitochondrial Dynamics","Inflammation","2026-05-18",{"date":122,"type":42},"2026-05-22",{"date":124,"type":42},"2025-12-12",{"date":126,"type":20},"2030-09-30",{"name":128,"class":76},"Oregon Health and Science University",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":136,"sex":16,"minAge":58,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":50},"100527028","mtbi-identification-and-monitoring-through-retinal-scanning-100527028","NCT06142435","mTBI Identification and Monitoring Through Retinal Scanning","Mild Traumatic Brain Injury Identification and Monitoring Through Retional Scanning","Inclusion Criteria:\n\n1. Age 18-45 years\n2. Presents to the facility within 2 weeks of head trauma\n3. Able to provide informed consent\n\n   * If minor, then able to provide parental consent and minor consent\n4. Able to participate in the examination, including the ability to follow simple instructions\n5. Fluency in English or Spanish\n\nExclusion Criteria:\n\n1. Glasgow Coma Scale score equal to or less than 13 at the time of study enrollment\n2. Under the influence of alcohol or drugs\n3. Previous eye surgery\n4. Visual acuity known to be 20\u002F200 or less in either eye\n5. Known strabismus, amblyopia (lazy eye), or double vision\n6. Known eye movement disorder, including nystagmus\n7. Known optic nerve disease, including papilledema or optic neuropathy\n8. Known retinal disease, including macular degeneration or retinal degeneration\n9. Known cataract\n10. History of neurosurgery\n11. History of stroke\u002Fbrain hemorrhage, brain tumor, or epilepsy\n12. Any head trauma requiring medical attention from a physician within the last 6 months\n13. Diagnosed dementia or cognitive impairment requiring assistance for daily living\n14. Other condition(s) under the care of a neurologist\n15. Psychiatric hospitalization in the last 90 days\n16. Subject considered unsuitable for participation in this clinical trial by PI, treating clinician, or study research staff\n17. Any minor brain injury regardless of loss of consciousness",true,"45 Years",{"count":139,"type":20},60,"Rebion has developed a device, the Rebion trauma tool (referred to as the head and intraocular trauma tool, or \"HITT\"), that detects ocular fixation and alignment using a binocular retinal scan. Preliminary data obtained from hospitalized patients with a clinically-confirmed traumatic brain injury (TBI) and uninjured controls indicates that the device can detect changes in ocular fixation, alignment, and saccades that are related to brain injury. This study seeks to evaluate the ability of the Rebion trauma tool to assess perturbations in eye movements resulting from TBI. The study will enroll 60 TBI patients and 20 controls.",[25],{"date":143,"type":42},"2026-05-20",{"date":145,"type":42},"2023-08-15",{"date":147,"type":20},"2026-08-31",{"name":149,"class":150},"Rebiscan, Inc.","INDUSTRY",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":110,"phases":160,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"100393226","phase-4-buspirone-and-melatonin-for-depression-following-traumatic-brain-injury-100393226","NCT04400266","Buspirone and Melatonin for Depression Following Traumatic Brain Injury","Inclusion Criteria:\n\nPatients with mild or moderate TBI will be included. To be included, a subject must meet the criteria below:\n\n1. Non-penetrating mild or moderate traumatic brain injury that occurred 3 or more months prior to study entry (to minimize natural recovery from TBI)\n2. Age: 18-64 years\n3. Meeting any one of the following severity criteria, as documented in the patient's medical records:\n\n   1. Glasgow Coma Scale (GCS) score of 9-15 within 4 hours after injury\n   2. Loss of consciousness (LOC) \\>1 minute and \\\u003C=24 hours\n   3. Post-traumatic amnesia (PTA) \\\u003C 7 days\n4. English-speaking\n5. Current DSM-5 diagnosis of Major Depressive Episode by medical record diagnosis\n6. HAM-D-21 score of 18 or higher\n7. Patients who are considered to be appropriate by their clinician and who are willing to be started on Buspirone and Melatonin for clinical purposes.\n\nExclusion Criteria:\n\n1. History of neurological disorder (e.g., stroke, epilepsy, multiple sclerosis, HIV, neurodegenerative disorders) or any acute or unstable medical condition that is likely to interfere with the assessments or with participation in treatment, as determined by history by the patient or review of their medical records.\n2. Evidence from the history of TBI severity greater than moderate, i.e., GCS of 8 or less, LOC \\> 24 hours, or PTA \\> 7 days.\n3. Inability to attend regular appointments\n4. Imminent risk of suicide, as determined by the assessing clinician; HAM-D, Question 3, answers \\> 1; SDQ, Question 11, answers \\> 3; spontaneous expressions of suicidal ideation will result in emergency evaluation by a licensed clinician member of study staff for appropriate assessment and triage.\n5. Lifetime history of schizophrenia or other primary psychotic disorders, as determined by history by the patient or review of their medical records.\n6. History of bipolar disorder, as determined by history by the patient or review of their medical records.\n7. Alcohol or substance dependence in the past 3 months, as determined by history by the patient or review of their medical records.\n8. Pregnancy or breast-feeding\n9. Concomitant use of buspirone, any psychostimulant, or modafinil\u002Farmodafinil\n10. Patients currently on an antidepressant or who have been on antidepressant in the past 4 weeks\n11. Patients with prior intolerances to buspirone or melatonin.\n12. Conditions that would preclude a subject from participating in the MRI procedures (e.g., metal implants, aneurysm clips, shrapnel\u002Fretained particles, pacemakers, claustrophobia).","64 Years",{"count":159,"type":20},10,[161],"PHASE4","Traumatic brain injuries (TBIs) are common. Post-TBI depression is associated with anxiety, aggression, fatigue, distractibility, anger, irritability, and rumination. The current research group conducted a pilot clinical trial, which investigated the novel treatment combination of buspirone and melatonin (B+MEL) in outpatients with clinical depression. Compared to placebo, B+MEL was associated with a significant improvement in depressive symptoms. Depression following TBI may be different from clinical depression. The B+MEL combination has never been studied in patients with post-TBI depression. The B+MEL has shown promise in ameliorating cognitive difficulties in people with depression. Because cognitive problems are typical in people with post-TBI depression, we plan to measure the effect of the B+MEL combination on cognitive ability in post-TBI depression. Additionally, we are interested in measuring functional magnetic resonance imaging changes before and after treatment with B+MEL in order to gain insight into the brain mechanisms of our hypothesized clinical symptom changes.\n\nThe goals of the proposed pilot research project are to assess changes in symptoms in patients with post-TBI depression following Buspirone + Melatonin combination (B+MEL), and the corresponding brain mechanisms underlying these hypothesized changes by measuring: 1) depressive symptoms; 2) cognitive symptoms; 3) functional magnetic resonance imaging.",[164,25],"Depression","2026-05-05",{"date":167,"type":42},"2026-05-06",{"date":169,"type":42},"2020-08-01",{"date":171,"type":20},"2028-07-31",{"name":173,"class":76},"Massachusetts General Hospital",2,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":110,"phases":185,"briefSummary":186,"conditions":187,"keywords":188,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":174},"100279700","mild-tbi-assessment--rehabilitation-100279700","NCT02920788","Mild TBI Assessment & Rehabilitation","Multi-Level Assessment and Rehabilitation of Combat Mild TBI","MTAR","Inclusion Criteria:\n\nFor TBI-positive veteran participants, to be randomized to either GOALS or TAU:\n\n* Ages 18+\n* A history of mild TBI (as defined by DOD \u002F VA; confirmed by medical records and in person Ohio State University TBI Instrument)\n* Chronic, stable phase of recovery (\\>6 months from last post-concussive event)\n* Report of residual cognitive difficulties (1 moderate or severe cognitive symptom(s) on the Neurobehavioral Symptom Inventory (NSI)) that interfere(s) with daily function\n* Able and willing to commit to participate in training and assessments\n* If on psychoactive medications, must be stable on medications (\\> 30 days)\n\nFor the TBI-negative healthy veteran control group:\n\n* Ages 18+\n* No history of any (mild to severe) TBI (as defined by DOD \u002F VA; confirmed by medical records and in person Ohio State University TBI Instrument)\n* Able and willing to commit to participate in assessments\n* If on psychoactive medications, must be stable on medications (\\> 30 days)\n\nExclusion Criteria:\n\nFor the TBI-positive veteran participants, to be randomized to either GOALS or TAU:\n\n* A history of moderate or severe TBI\n* Unstable medical, neurologic, or psychiatric condition, including severe cognitive dysfunction, or other reasons for being unable or unwilling to participate in study procedures (e.g., contraindications to MRI)\n* Ongoing illicit drug or alcohol abuse (AUDIT\\>8)\n* Psychosis\n* Severe depression, anxiety or PTSD that precludes participation in research activities\n* Poor English comprehension\n* Eligible participants may have other co-morbid stable neuropsychiatric disorders, including depression and PTSD\n* There will be no restriction in regard to gender, race and socioeconomic status\n\nFor the TBI-negative healthy veteran control group:\n\n* A history of any mild, moderate, or severe TBI\n* Unstable medical, neurologic, or psychiatric condition, including severe cognitive dysfunction, or other reasons for being unable or unwilling to participate in study procedures (e.g. contraindications to MRI)\n* Ongoing illicit drug or alcohol abuse (AUDIT\\>8)\n* Psychosis\n* Severe depression, anxiety or PTSD that precludes participation in research activities\n* Poor English comprehension\n* Eligible participants may have other co-morbid stable neuropsychiatric disorders, including depression and PTSD.\n* There will be no restriction in regard to gender, race and socioeconomic status",{"count":184,"type":20},65,[112],"One of the most pressing concerns within the VA currently is the provision of interventions that address the cognitive as well as emotional problems faced by Veterans with mild TBI and comorbid conditions. When completed, these studies will inform us whether training core attentional self-regulatory control functions via personally-relevant activities will be effective in improving daily life for Veterans with mild TBI and comorbid conditions. The study design will provide a test not only of potential benefits for real life functioning, but also determine to what extent these benefits are related to actual changes in cognitive\u002Fbehavioral performance and brain networks corresponding to these functions. This project will provide a foundation for future studies to investigate the neural mechanisms that support improvements of cognition and behavior in mTBI.",[25],[189,190],"Rehabilitation","Functional Magnetic Resonance Imaging",{"date":167,"type":42},{"date":193,"type":42},"2017-03-09",{"date":195,"type":20},"2027-04-13",{"name":197,"class":198},"VA Office of Research and Development","FED",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":207,"conditions":208,"keywords":214,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":50},"100637552","prospective-observational-multimodal-neuromonitoring-in-adult-nsicu-patients-100637552","NCT07577713","Prospective Observational Multimodal Neuromonitoring in Adult NSICU Patients","Prospective Observational Multimodal Neuromonitoring in Adult Neurosciences Intensive Care Unit Patients: Characterization of Noninvasive Cerebral Autoregulation Indices, Quantitative EEG, and Physiologic Correlates Across NSICU Diagnoses","Inclusion Criteria:\n\n* Age 18 years or older\n* Admitted to the NSICU at UT Southwestern Medical Center\n* Informed consent obtained from subject or legally authorized representative (as defined under Texas Health and Safety Code Section 166.039), or consent process underway per institutional policy\n* At least one study monitoring modality feasible (SedLine qEEG and\u002For Brain4Care extensometry); NIRS data collected where already in standard clinical use\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Prisoner status\n* Active declination of participation by subject or legally authorized representative\n* Absence of both subject and legally authorized representative consent when required\n* Clinical condition preventing safe placement of any study monitor (e.g., extensive facial or scalp injury, surgical dressings or hardware at all possible sensor sites, open wounds at sensor locations, severe uncontrolled agitation)\n* Anticipated clinical data capture insufficient for meaningful analysis\n* Urgent clinical priorities making research monitor placement inappropriate at time of approach\n* Inability to provide informed consent in English; study consent materials are available in English only",{"count":109,"type":20},"This is a prospective observational cohort study of adult patients admitted to the Neurosciences Intensive Care Unit (NSICU) at UT Southwestern Medical Center. The study acquires multimodal neuromonitoring data - including SedLine quantitative EEG (qEEG) from standard-of-care monitoring, Brain4Care (B4C) noninvasive intracranial dynamics monitoring, and near-infrared spectroscopy (NIRS)-derived cerebral autoregulation (CA) indices where NIRS is already in clinical use - and links these data to bedside physiologic, medication, diagnostic, and clinical outcome variables during standard care. No alteration of clinical management occurs. The study prioritizes aneurysmal subarachnoid hemorrhage (aSAH) patients to characterize the natural history of noninvasive CA parameter evolution through the delayed cerebral ischemia (DCI) window (admission through Day 14) and provides preliminary data for subsequent interventional study design.",[209,25,210,211,212,213],"Subarachnoid Hemorrhage, Aneurysmal","Cerebral Hemorrhage","Ischemic Stroke","Delayed Emergence From Anesthesia","Encephalopathy",[215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231],"aneurysmal subarachnoid hemorrhage","delayed cerebral ischemia","cerebral autoregulation","CPPopt","MAPopt","Brain4Care","SedLine","quantitative EEG","near-infrared spectroscopy","COx","TOxA","transcranial Doppler","neurocritical care","NSICU","noninvasive intracranial monitoring","Moberg Clinical Platform","multimodal neuromonitoring","2026-05-04",{"date":234,"type":42},"2026-05-11",{"date":236,"type":20},"2026-07",{"date":238,"type":20},"2029-09",{"name":240,"class":76},"University of Texas Southwestern Medical Center",{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":249,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":110,"phases":251,"briefSummary":252,"conditions":253,"keywords":254,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":267},"100459350","brain-injury-education-and-outpatient-navigation-1stbien-100459350","NCT05261477","Brain Injury Education and Outpatient Navigation-1stBIEN","Brain Injury Education and Outpatient Navigation for Hispanic Children and Their Caregivers-1stBIEN","1st-BIEN","Children Inclusion criteria:\n\n1. Children 3 to 17 years of age,\n2. Hispanic ethnicity\n3. Diagnosis of mild, moderate or severe TBI.\n4. Hospitalization at one of the 5 academic institutions participating in this trial,\n5. Treatment requiring at least one type of rehabilitation therapy as outpatient\n\nParent Inclusion Criteria:\n\n1. Hispanic ethnicity\n2. Being the primary caregiver for the child (For longitudinal follow-up purposes)\n\nExclusion criteria:\n\nChild:\n\n1. Prior neurological deficits,\n2. Acquired brain injuries secondary to other conditions different from trauma.\n3. Traumatic brain injuries secondary to abusive trauma.\n\nParent:\n\n1. Loss of custody of the child (i.e. abusive head trauma)\n2. Inability to be contacted by phone","3 Years",{"count":109,"type":20},[112],"Traumatic brain injury (TBI) is a significant problem for U.S. Hispanic children. Compared to non-Hispanic children, Hispanic children have higher long-term disability and lower health related quality of life, even though differences are not present at hospital discharge. Rehabilitation decreases disability, but needs timely initiation, and long treatments in hospitals, community healthcare facilities and schools. Parents play a key role in their child's recovery. Hispanic parents face additional barriers to initiate and maintain outpatient treatments. They report knowledge gaps in TBI-education, community, and school support systems; language and health literacy barriers. The investigators developed, a bilingual bicultural theory-based program for Hispanic families consisting of Brain Injury Education and outpatient care Navigation (1st BIEN). It integrates in-person education enriched by video content delivered through mobile phones, with navigation during transitions to outpatient care and school return. The pilot established feasibility and acceptability of the program. This randomized control trial will determine efficacy to maintain long-term adherence to rehabilitation and reduce disability. It will enroll 150 parent-child dyads: children (6-17 y), with mild-complicated, moderate-severe TBI in 5 centers in Washington, Texas, Dallas, Utah and Oregon and their parents. Intervention group parents receive: One in-person education session, plus bi-weekly videos tailored to the child's TBI and therapies; and, 3-months of bilingual outpatient care navigation. Attention control parents receive one in person-education session, monthly well-child texts and usual institutional follow up care. Primary outcome is treatment adherence at 6 months post-discharge measured by percentage of follow-up appointments attended during the prescribed time at hospitals, and community care facilities. Secondary outcomes are functional status of the child using PROMIS parental report measures; and parental health literacy, self-efficacy, and mental health at 3, 6, and 12 months after discharge. Child's academic performance will be assessed using school records. The study evaluates a flexible and scalable intervention using mobile phones to aid transitions of care, improve treatment adherence and TBI outcomes. It addresses the needs of an understudied population and can serve as a model for TBI family centered care for at risk groups.",[25,189],[255,256,25,257,189],"Hispanic or Latino","Child","Patient Navigation","2026-01-11",{"date":260,"type":42},"2026-01-13",{"date":262,"type":42},"2022-07-07",{"date":264,"type":20},"2026-12",{"name":266,"class":76},"Seattle Children's Hospital",6,{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":16,"minAge":276,"maxAge":17,"enrollmentInfo":277,"targetDuration":4,"studyType":110,"phases":279,"briefSummary":281,"conditions":282,"keywords":286,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":4},"100392231","phase-3-traumatic-injury-clinical-trial-evaluating-tranexamic-acid-in-children-an-efficacy-study-100392231","NCT04387305","Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: An Efficacy Study","Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children (TIC-TOC): An Efficacy Study","TIC-TOC","Inclusion Criteria:\n\n1. Less than 18 years old AND\n2. Penetrating torso trauma, blunt torso trauma, or head trauma as defined below:\n3. Penetrating Torso Trauma:\n\n   a. Penetrating trauma to the chest, abdomen, neck, or pelvis with at least one of the following:\n   * age-adjusted hypotension, or\n   * age-adjusted tachycardia despite adequate resuscitation fluids, or\n   * radiographic evidence of internal hemorrhage, or\n   * clinician suspicion of ongoing internal hemorrhage\n4. Blunt Torso Trauma:\n\n   1. Clinician suspicion of hemorrhagic blunt torso injury and at least one of the following:\n\n      * age-adjusted hypotension, or\n      * age-adjusted tachycardia despite adequate resuscitation fluids\n   2. Hemothorax on chest tube placement or imaging,\n   3. Clinical suspicion of hemorrhagic blunt torso injury and Intraperitoneal fluid on abdominal ultrasonography (Focused Assessment with Sonography in Trauma),\n   4. Intra-abdominal injury on CT with either contrast extravasation or more than trace intraperitoneal fluid,\n   5. Pelvic fracture with contrast extravasation or hematoma on abdominal\u002Fpelvic CT scan with at least one of the following:\n\n      * Age-adjusted hypotension, or\n      * Age-adjusted tachycardia.\n5. Head Trauma:\n\n   1. Initial Glasgow Coma Scale (GCS) score 3 to 13 with associated intracranial hemorrhage on cranial CT scan (enroll after cranial CT scan)\n\nExclusion Criteria:\n\n* Unable to administer study drug within 3 hours of traumatic event\n* Known pregnancy\n* Known ward of the state\n* Cardiac arrest prior to randomization\n* GCS score of 3 with bilateral unresponsive pupils\n* Isolated subarachnoid hemorrhage, epidural hematoma, or diffuse axonal injury\n* Known venous or arterial thrombosis\n* Known bleeding\u002Fclotting disorders\n* Known seizure disorders\n* Known history of severe renal impairment\n* Known allergy to TXA\n* Unknown time of injury (includes suspected non-accidental trauma)\n* Previous enrollment into the TIC-TOC trial\n* Prior TXA for current injury\n* Prior opt-out\n* Non-English and non-Spanish speaking","0 Years",{"count":278,"type":20},2000,[280],"PHASE3","Trauma is the leading cause of death and disability in children in the United States. The objective of this study is to evaluate the benefits and harms of tranexamic acid (TXA; a drug that stops bleeding) in severely injured children with hemorrhagic brain and\u002For torso injuries. Using thromboelastography, we will measure baseline fibrinolysis to assess for treatment effects of TXA at different levels of fibrinolysis.",[25,283,284,285],"Wounds and Injury","Hemorrhage","Trauma Injury",[287,288,284,289,290,291,292],"Tranexamic acid","Brain Injuries","Clinical Trial","Children","Pediatric","Trauma","2025-12-09",{"date":295,"type":42},"2025-12-15",{"date":297,"type":20},"2026-10-01",{"date":299,"type":20},"2031-03-31",{"name":301,"class":76},"Daniel Nishijima, MD, MAS",{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":136,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":308,"targetDuration":4,"studyType":110,"phases":309,"briefSummary":310,"conditions":311,"keywords":313,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":50},"100330112","morning-bright-light-to-improve-sleep-quality-in-veterans-100330112","NCT03578003","Morning Bright Light to Improve Sleep Quality in Veterans","Inclusion Criteria:\n\n* Veterans\n\nExclusion Criteria:\n\n* History of bipolar disorder\n* History of macular degeneration\n* Non-English speaking\n* Decisionally impaired\n* Currently using a light box",{"count":19,"type":20},[112],"One of the principal complicating factors associated with traumatic brain injury (TBI) is sleep-wake disturbances (e.g., insomnia, excessive daytime sleepiness, and circadian rhythm sleep disorders). Morning bright light therapy (MBLT) has been shown to improve sleep quality in a variety of conditions, but little has been done investigating the utility of MBLT in improving sleep in Veterans with TBI. This proposal aims to determine the effect of MBLT on sleep quality in Veterans with TBI. Veterans with and without TBI will be recruited from the VA Portland Health Care System. Baseline questionnaires and 7 days of actigraphy will be collected prior to engaging in 60 minutes of MBLT daily for 4 weeks, during which actigraphy will also be collected continuously. Post-MBLT questionnaire data will be collected, and follow-up questionnaire data will be collected at 3 months post-MBLT.",[25,312],"Post-traumatic Stress Disorder",[115,314],"Bright Light","2025-11-12",{"date":317,"type":42},"2025-11-14",{"date":319,"type":42},"2017-08-02",{"date":321,"type":20},"2026-12-01",{"name":323,"class":198},"Portland VA Medical Center",{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":332,"enrollmentInfo":333,"targetDuration":4,"studyType":110,"phases":335,"briefSummary":336,"conditions":337,"keywords":347,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":174},"100547838","remotely-supervised-tdcs-for-complex-attention-in-mtbi-cognetric-100547838","NCT06413173","Remotely Supervised tDCS+ for Complex Attention in mTBI (Cognetric)","Remotely Supervised tDCS Combined With Cognitive Training to Improve Complex Attention in Active Duty Service Members and Veterans With Mild TBI (Cognetric)","COGNETRIC","Inclusion Criteria:\n\n1. Active-Duty Service Members.\n2. Ages 18 to 60.\n3. All genders.\n4. All racial and ethnic groups.\n5. History of mild TBI (as defined by the DOD\u002FVA criteria used in conjunction with the OSU TBI-ID) sustained at least 3 months and no more than 10 years prior to enrollment.\n6. Self-reported attention and\u002For concentration difficulties.\n7. At least one cognitive symptom reported on the Neurobehavioral Symptom Inventory (NSI) cognitive subscale.\n\nExclusion Criteria:\n\n1. Presence of a medical, psychiatric, physical or non-physical disease, disorder, condition, injury, disability or pre-existent history such that study participation, in the opinion of the PI: (a) may pose a significant risk to the participant; (b) raises the possibility that the participant is unlikely to successfully complete all of the requirements of the study according to the study protocol; or (c) might adversely impact the integrity of the data or the validity of the study results. Specific conditions include (but are not limited to) a history of: brain tumor, epilepsy, cerebral vascular accident (CVA), Schizophrenia, Bipolar Disorder, and Mania.\n2. History of prior treatment with ECT or neuromodulation in the last 12 months.\n3. Current, diagnosed substance dependence.\n4. Newly prescribed medication within the previous 3 weeks.\n5. Diagnosis of intellectual disability or pervasive developmental disorder (i.e., premorbid IQ less than or equal to 70).\n6. Any medical condition or treatment other than mild TBI (e.g., stroke, tumor, HIV, moderate-severe TBI), with significant neurological disorder or insults that, based on the Principal Investigator's judgment, would impact risk.\n7. Psychosis or mania within 30 days of enrollment, as determined by the PI, based on a psychiatric history and examination and\u002For a review of available medical records\n8. Contraindications for tDCS (e.g., metallic cranial plates\u002Fscrews or implanted device, eczema or skin lesions on scalp)\n9. A positive pregnancy report.","60 Years",{"count":334,"type":20},160,[112],"The proposed study will evaluate a new approach to cognitive rehabilitation of mTBI using a brain stimulation technique called \"Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training\" (RS-tDCS+) which has shown promise for improving complex attention in both healthy and clinical populations. RS-tDCS+ is a home-based, low-risk, non-invasive technique that is designed to boost cognitive training by enhancing learning and the brain's ability to reorganize connections. This study will evaluate RS-tDCS+ for improving complex attention in Active Duty Service Members (ADSM) and Veterans with a history of mTBI. Different tests of complex attention and symptom questionnaires will be used to determine the effects of real versus sham (placebo) RS-tDCS+. Second, the investigators will investigate electrical and connectivity changes in the brain associated with RS-tDCS+ using electroencephalogram (EEG) and magnetic resonance imaging (MRI). Third, the investigators will investigate the lasting effects of any observed changes by evaluating participants at 1 and 6 weeks post-treatment. Lastly, the investigators will explore the impact of individual differences (e.g., PTSD, depression, sleep quality, time since injury, baseline impairment, age, sex, ADSM versus Veteran) on treatment outcome.",[338,339,340,288,25,341,342,343,344,345,346],"Brain Concussion","Brain Trauma","Attention Concentration Difficulty","Neurocognitive Dysfunction","Attention Impaired","Memory Impairment","Mild Traumatic Brain Injury","Mild Cognitive Impairment","Post Concussive Symptoms",[348,349,350,351,352,353],"Military Health","Brain Stimulation","Cognitive Training","Cognitive Rehabilitation","Telehealth","Neuromodulation","2025-11-07",{"date":315,"type":42},{"date":357,"type":42},"2024-07-25",{"date":359,"type":20},"2028-09-30",{"name":361,"class":198},"United States Naval Medical Center, San Diego",{"id":363,"slug":364,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":369,"enrollmentInfo":370,"targetDuration":4,"studyType":110,"phases":372,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":381,"leadSponsor":383,"locationsCount":50},"100561010","neurobalance-training-to-improve-postural-control-in-individuals-with-traumatic-brain-injury-100561010","NCT06584591","NEUROBALANCE Training to Improve Postural Control in Individuals With Traumatic Brain Injury","Neuromodulation-Enhanced Use of RObotic Balance Training to Improve Postural Control in Individuals With Traumatic Brain Injury","Inclusion Criteria:\n\n1. Aged between 18-75 years\n2. Diagnosed with a non-penetrating TBI at least six months before the screening.\n3. Have complaints of impaired balance and poor postural control determined by a BBS score of ≤50.\n4. Ability to stand upright with or without support for at least 20 seconds\n5. Ability to walk with or without a walking aid for at least ten meters\n6. Not planning to change medication in the next four months\n7. Minimum Cognitive Ability to understand the verbal instructions and comply with the study procedures, as determined by the University of California, San Diego, Brief Assessment of Capacity to Consent Instrument (UBACC).\n\nExclusion Criteria:\n\n1. Currently undergoing any regular physical therapy program or research studies focusing on balance functions.\n2. Having a stroke or a penetrating TBI.\n3. Affected by the peripheral nerve injury, neuromuscular conditions, or orthopedic issues of lower limbs before TBI, or have any persistent pain or difficulty maintaining blood pressure while upright.\n4. Have a scalp or skin condition (e.g., psoriasis or eczema) on the scalp near the stimulation site.\n5. Severe visual impairment (e.g., spatial neglect) or hearing problems may affect study compliance.\n6. Any other neurological injury or psychiatric conditions (e.g., severe anxiety or schizophrenia, etc.)\n7. Not being pregnant or thinking of becoming pregnant during the study period.\n8. Diagnosed with alcohol or substance abuse in the last three years.\n9. Contraindications to TMS, including the presence of metallic implants in the head and history of seizures or medication-resistant epilepsy.","75 Years",{"count":371,"type":20},45,[112],"Our proposed study, \\"NEUROBALANCE,\\" aims to evaluate the effectiveness of a combined intervention involving robotic balance training and noninvasive brain stimulation in improving balance functions in individuals with chronic traumatic brain injury (TBI). The study will recruit 45 participants who have had a TBI for over six months and experience persistent balance deficits. Participants will be randomized into three groups: (1) robotic balance training with active brain stimulation, (2) robotic balance training with sham brain stimulation, and (3) standard-of-care rehabilitation.\n\nThe study will involve 12 training sessions over four weeks, with assessments conducted at baseline, post-training, and two months post-training to evaluate balance recovery and retention. The primary focus is understanding how this intervention affects brain and muscle activity during balance tasks and how these changes translate into functional improvements in clinical outcome measures of balance function. Additionally, participant feedback on brain stimulation and exercise engagement will be collected to inform future studies.\n\nThis research is particularly relevant to military service members, as TBI and balance impairments are common among this population. The findings may guide the development of personalized training protocols and contribute to broader rehabilitation strategies.",[64,375,376,25],"TBI","Diffuse Axonal Brain Injury","2025-08-01",{"date":379,"type":42},"2025-08-06",{"date":377,"type":42},{"date":382,"type":20},"2027-12",{"name":384,"class":76},"Kessler Foundation",{"id":386,"slug":387,"hasResults":11,"nctId":388,"briefTitle":389,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":391,"enrollmentInfo":392,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":4},"100581786","the-value-of-combined-detection-of-different-blood-biomarkers-in-the-diagnosis-and-treatments-of-traumatic-brain-injury-100581786","NCT06854835","The Value of Combined Detection of Different Blood Biomarkers in the Diagnosis and Treatments of Traumatic Brain Injury","Inclusion Criteria:\n\n1. Age: 18-65 years old\n2. Time of injury: patients with acute traumatic brain injury within 24h\n3. Glasgow Coma Scale (Glasgow Coma Scale, GCS) score: 13 to 15 for patients with mild traumatic brain injury, 9 to 12 for moderate traumatic brain injury, and 3 to 8 for patients with severe traumatic brain injury\n4. No other system damage has occurred\n5. Admitted to hospital for the first diagnosis after the injury\n\nExclusion Criteria:\n\n1. With a history of neurological or psychiatric disorders\n2. Traumatic brain injury occurred before the injury\n3. History of alcohol or substance abuse\n4. Mild brain trauma is a complication of other injuries (systemic trauma, facial trauma, or spinal cord trauma) or other causes (psychological trauma, language impairment)\n5. Patients without visits, and incomplete data during treatment","65 Years",{"count":393,"type":20},80,"TBI, as a potential risk factor, causes a 1.5 times higher risk of neurodegenerative disease to up to 30-70% of TBI patients with neurological symptoms. Brain trauma is an important global medical, public health and social problem. Early diagnosis and effective treatment can effectively reduce the disability rate of patients and the incidence of neurological sequelae, and has increasingly become the focus of the international scientific research community. Exploring blood-based biomarkers has potential clinical value, which can greatly help clinicians to evaluate patients' conditions and develop reasonable plans, and then improve the clinical management and treatment of patients with craniocerebral trauma. Further research work is needed to be done to identify the most effective and efficient biomarker or combination marker strategies for integration into clinical treatment.",[25,396],"Biomarkers","2025-02-25",{"date":399,"type":42},"2025-03-03",{"date":401,"type":20},"2025-03-15",{"date":403,"type":20},"2027-07-31",{"name":405,"class":76},"First Affiliated Hospital Xi'an Jiaotong University",{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":413,"enrollmentInfo":414,"targetDuration":4,"studyType":110,"phases":416,"briefSummary":417,"conditions":418,"keywords":421,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":50},"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":415,"type":20},84,[112],"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.",[25,419,420,65],"Brain Injury Traumatic Severe","Brain Injury Traumatic Moderate",[422,423,424,425,426,427],"Environmental enrichment","spatial navigation","traumatic brain injury","neurorehabilitation","telerehabilitation","hippocampus","2024-11-21",{"date":430,"type":42},"2024-11-25",{"date":432,"type":42},"2018-10-30",{"date":434,"type":20},"2027-02",{"name":436,"class":76},"Toronto Rehabilitation Institute",{"id":438,"slug":439,"hasResults":11,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":110,"phases":447,"briefSummary":448,"conditions":449,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":459},"100446732","phase-4-ketamine-in-acute-brain-injury-patients-100446732","NCT05097261","Ketamine in Acute Brain Injury Patients.","Brain Injury and Ketamine: a Prospective, Randomized Controlled Double Blind Clinical Trial to Study the Effects of Ketamine on Sedative Sparing and Intracranial Pressure in Traumatic Brain Injury Patients.","BIKe","Inclusion Criteria:\n\n* Traumatic brain injury patients\n* Age \\>= 18 years\n* Admitted to the ICU\n* Within 72 hours after admission to the initial hospital:\n\n  * ICP monitoring in place (parenchymal probe, ventricular catheter, or both)\n  * Requiring sedation\n\nExclusion Criteria:\n\n* Known pregnancy and\u002For lactation\n* Imminent or actual brain death upon inclusion\n* Allergy or intolerance to the study medication\n* Pre-existing neurocognitive disorders, pre-existing congenital or non-congenital brain dysfunction.\n* Inability to obtain informed consent\n* Inclusion in an interventional randomised controlled trial of which the PI indicates that co-inclusion specifically in the BIKe study is prohibited.\n* Therapy restriction code upon inclusion.\n* Porphyria\n* Glaucoma",{"count":446,"type":20},100,[161],"Although, in the past years, an increasing use of ketamine in Traumatic Brain injury (TBI) has been reported as an adjunct to other sedatives, there is no evidence from randomized clinical trial to support this practice.\n\nThe BIKe (Brain Injury and Ketamine) study is a double-blind placebo controlled randomized multicenter clinical trial to examine the safety and feasibility of using ketamine as an adjunct to a standard sedative strategy in TBI patients.",[25],"2024-08-21",{"date":452,"type":42},"2024-08-22",{"date":454,"type":42},"2021-09-06",{"date":456,"type":20},"2026-06-30",{"name":458,"class":76},"Geert Meyfroidt, MD, PhD",8,{"id":461,"slug":462,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":468,"targetDuration":470,"studyType":21,"phases":4,"briefSummary":471,"conditions":472,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":482},"100513384","validation-of-the-scandinavian-guidelines-for-minor-and-moderate-head-trauma-in-children-100513384","NCT05964764","Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children","A Pragmatic, Prospective, Multicentre Study for the Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children","SHIPP","Inclusion Criteria:\n\n* Age \\\u003C18 years.\n* Minor and moderate blunt head trauma (GCS 9 - 15) seeking medical assessment in an emergency department at a study hospital in Sweden or Norway.\n* Within 24 hours of trauma.\n* Informed oral consent from one guardian, and child if older than 14 years old, after receiving oral and written information about study.\n\nExclusion Criteria:\n\n* Patient and\u002For guardian does not wish to participate in the study.\n* Patient included in other study that may affect the management\u002Ftreatment in the emergency department.\n* Penetrating head injury (as those will always receive a CT scan).\n* Suspected child abuse \u002F non-accidental trauma (NAT) denoted as suspected child abuse where the social services are informed (as they will always receive a CT scan).\n* The patient is not a citizen in the participating country and hence difficult to follow up.",{"count":469,"type":20},5300,"4 Months","Head injuries are common among children and adolescents, with many of them assessed in emergency departments each year. Most children recover fast, with full resolution of symptoms as headache, dizziness or fatigue. A few, however, develop life-threatening complications (such as bleedings in\u002Faround the brain). It can be difficult to swiftly and accurately identify these patients in the emergency department. To aid in this task, decision support tools has been developed.\n\nThe goal of this observational study is to evaluate a Scandinavian tool developed to aid in management of children with head injuries seeking care in an emergency department.\n\nThe main research question is:\n\n\\- Are the Scandinavian guidelines for management of mild and moderate head trauma in children sensitive for patient-important outcomes?\n\nPatients will be given the same treatment and recommendations for their head injury no matter if they participate or not in the study, as there is no intervention\u002F treatment group.\n\nThe doctor or nurse managing the child will collect information on patient history, signs and symptoms in the emergency department and management in an electronic case report form. Information on how the recovery period is collected both from medical records \\>1 month after the emergency department visit, as well as via electronic questionnaires sent to the guardian at 1 month, 3 months and 4 months after the injury via e-mail and\u002For text message. Long-term outcome will also be examined (\\>6 months).",[25],"2024-02-27",{"date":475,"type":42},"2024-02-28",{"date":477,"type":42},"2018-04-01",{"date":479,"type":20},"2029-12-31",{"name":481,"class":76},"Halmstad County Hospital",16]