[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"severe-traumatic-brain-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:severe-traumatic-brain-injury":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,39,74,108,137,172,206,233,261,294],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100645218","the-systemic-nature-of-severe-traumatic-brain-injury-100645218",false,"NCT07679126","The Systemic Nature of Severe Traumatic Brain Injury","The Systemic Nature of Severe Traumatic Brain Injury: Multi-Omic Analysis of Neural Trauma, Autoantibodies and the Gut-Brain Axis: The MANTRA Study","MANTRA","Inclusion Criteria:\n\n* All patients must be between the ages of 18 to 65 at time of enrollment\n* Study group cohort will consist of at least 20 patients admitted with severe TBI, defined as a GSC less than or equal to 8 with evidence of intracranial pathology on imaging.\n* Trauma control cohort will include at least 10 patients matched on demographics and injury patterns without traumatic brain injury.\n* Healthy control cohort will be comprised of 10 patients without acute traumatic injury or illness, matched to the sTBI patients based on demographics and medical comorbidities.\n\nExclusion Criteria:\n\n* Pregnant Patients\n* Prisoners\n* Patients less than 18 years of age or greater than 65 years of age\n* Patients with a penetrating brain injury mechanism, known neurodegenerative or psychiatric disorders, prior known traumatic brain injury, intracranial neoplasm, patients receiving massing transfusion or blood products prior to arrival, terminal illness or not expected to survive, confirmed or suspected brain death, known autoimmune or immunological condition, receiving immunosuppressant or immunomodulatory therapies, having a cardiac event leading to the injury, or for whom consent is unable to be obtained.",true,"ALL","18 Years","65 Years",{"count":22,"type":23},40,"ESTIMATED","OBSERVATIONAL","Severe Traumatic brain injury (sTBI) is a very serious problem, and right now, doctors don't have special treatments to help stop additional injury. Previous studies showed that when a young person gets this kind of brain injury, their body's defense system reacts quickly and strongly. This can cause problems with the brain's protective barrier breaking down and the body making antibodies that attack its own cells. We think that changes in how the brain and the gut (the part of your body that digests food) talk to each other might make these defense reactions stronger. This study wants to figure out exactly how brain injuries change the gut and how that affects the body's defenses. To do this, we will use new ways to study body chemicals and genes \\[RNA, cell free DNA (cfDNA) and blood chemistry\\] to help us learn why the body reacts this way and how it can lead to more brain injuries and problems in adults with serious brain injuries.",[27],"Severe Traumatic Brain Injury","NOT_YET_RECRUITING","2026-06-25",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":31,"type":23},{"date":35,"type":23},"2029-07-01",{"name":37,"class":38},"Corewell Health West","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100640910","phase-2-feasibility-and-safety-of-targeting-neutral-vs-liberal-fluid-balance-in-traumatic-brain-injured-patients--limit-tbi-trial-100640910","NCT07625995","Feasibility and Safety of Targeting Neutral vs Liberal Fluid Balance in Traumatic Brain Injured Patients- LIMIT-TBI Trial","Feasibility and Safety of Targeting Neutral vs Liberal Fluid Balance in Traumatic Brain Injured Patients: a Phase II Randomized Controlled Trial - LIMIT-TBI Trial","LIMIT-TBI","Inclusion Criteria:\n\n* Adult patients with traumatic brain injury (isolated or associated with extracranial injuries), with or without intracranial pressure monitoring\n* Admission to the intensive care unit\n* Age \\>18 years\n* Enrollment within 48 hours after ICU admission\n\nExclusion Criteria:\n\n* Enrollment in another clinical trial not approved for co-enrollment\n* Pregnancy or suspected pregnancy\n* Concomitant hemorrhagic shock expected to require surgical treatment within 24 hours from inclusion or requiring massive transfusion protocol\n* Hemodynamic instability at ICU admission, defined as heart rate \\>120 beats\u002Fmin and systolic arterial pressure \\\u003C100 mmHg despite at least 1 L of fluid resuscitation, or requirement for high-dose norepinephrine (\\>0.5 mcg\u002Fkg\u002Fmin) or any inotropic support\n* Need for continuous venovenous hemodiafiltration (CVVHDF) at admission\n* Expected survival \\\u003C48 hours",{"count":48,"type":23},88,"INTERVENTIONAL",[51],"PHASE2","The LIMIT-TBI trial is a multicenter, international, randomized, phase II clinical trial designed to evaluate the feasibility and safety of targeting a neutral fluid balance compared to standard care in critically ill adult patients with traumatic brain injury (TBI).\n\nFluid therapy is a cornerstone of TBI management, but optimal fluid balance remains uncertain, with both fluid overload and restriction potentially leading to adverse outcomes. This study aims to determine whether maintaining a daily fluid balance close to zero (±500 mL) during the first 5 days of ICU admission is achievable and safe.\n\nParticipants will be randomized within 48 hours of ICU admission to either a protocolized neutral fluid balance strategy or standard care. Outcomes include feasibility of achieving the target balance, organ complications, hemodynamic parameters, ICU resource utilization, and mortality and neurological outcomes up to 6 months.",[54,27,55,56],"Traumatic Brain Injury","Acute Brain Injury","Neurocritical Care",[58,59,60,61,62],"Fluid Balance","Fluid Therapy","Hemodynamic Management","Feasibility Study","Intracranial Pressure","RECRUITING","2026-05-30",{"date":66,"type":32},"2026-06-04",{"date":68,"type":32},"2025-07-01",{"date":70,"type":23},"2029-02",{"name":72,"class":38},"Erasme University Hospital",3,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":17,"sex":18,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":49,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100636049","seeme-using-automated-facial-tracking-to-detect-voluntary-behavior-in-brain-injury-100636049","NCT07560631","SeeMe: Using Automated Facial Tracking to Detect Voluntary Behavior in Brain Injury","SeeMe: A Multimodal Behavioral-Electrophysiological Tool for Real-Time Detection of Motor Behavior in Brain Injury Patients","Group 1: Traumatic Brain Injury (TBI) Cohort\n\nInclusion Criteria:\n\n* Adults (22+) with a history of acute traumatic brain injury\n* Documented loss of consciousness with a Glasgow Coma Scale (GCS) score less than or equal to 8 upon hospitalization\n* Clinically stable as determined by the primary neurosurgery or ICU team\n* Intact auditory pathways as confirmed by BAERs\n* Family consent for study participation\n\nExclusion Criteria:\n\n* Hearing Impairment confirmed via absence of Brainstem Auditory Evoked Responses (BAERs) that would prevent the patient from hearing the auditory commands\n* No legal authorized representative (LAR) available to provide informed consent for the patients in a comatose state\n* Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe.\n* Pregnant women\n* Any previous history of traumatic brain injury\n* Any neurodegenerative disease such as dementia\n\nGroup 2: Healthy Control Cohort\n\nInclusion Criteria:\n\n* Adults 22+ with no history of neurological or psychiatric disorders\n* Normal baseline neurological examination\n* Intact auditory pathways\n* Ability to provide informed consent\n* Ability to follow simple auditory commands in English\n\nExclusion Criteria:\n\n* Hearing Impairment that would prevent the participant from hearing the auditory commands\n* Any previous history of severe traumatic brain injury (TBI)\n* Any neurodegenerative disease (e.g., dementia)\n* Any motor impairment (e.g., facial palsy, carpal tunnel syndrome) that would interfere with facial or hand movement tracking\n* Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe\n* Pregnant women\n\nGroup 3: Sedated\u002FAnesthetized Cohort\n\nInclusion Criteria:\n\n* Adults (22+) undergoing elective spine surgery\n* Requirement of general anesthesia and pharmacological paralysis (neuromuscular blockade) as part of the standard surgical procedure\n* Clinically stable for study procedures as determined by the anesthesia and surgical teams.\n* Intact auditory pathways\n* Ability to provide informed pre-operative consent\n\nExclusion Criteria:\n\n* Hearing Impairment that would prevent the patient from hearing the auditory commands\n* Any previous history of severe traumatic brain injury\n* Any neurodegenerative disease such as dementia\n* Significant baseline facial or hand motor deficits prior to the administration of anesthesia\n* Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe\n* Pregnant women","22 Years","85 Years",{"count":84,"type":23},80,[86],"NA","Objective: This prospective interventional study introduces \"SeeMe,\" an automated, high-resolution computer vision platform designed to objectively quantify microscopic, auditory command-evoked movements in patients with Traumatic Brain Injury (TBI). Current clinical assessments, such as the Glasgow Coma Scale (GCS) and Coma Recovery Scale-Revised (CRS-R), rely on subjective human observation and often fail to detect low-amplitude motor responses, potentially misclassifying up to 25% of patients as unresponsive.\n\nMethodology: SeeMe utilizes vector analysis, cross-correlation, and deep neural networks (DNNs) to track individual facial pores and hand movements with sub-millimeter precision (0.5 mm) and high temporal resolution (0.03s). The study will enroll a cohort of 60-80 TBI patients, alongside healthy controls and pharmacologically paralyzed subjects, to validate SeeMe's sensitivity and specificity.\n\nPrimary Goals:\n\n1. Validation: Compare SeeMe's detection of voluntary motor recovery against gold-standard clinical examinations (CRS-R).\n2. Synchronization: Simultaneously record and time-lock electroencephalography (EEG) and electrocorticography (ECoG) with SeeMe-detected movements.\n3. Biomarker Identification: Characterize neural signatures (specifically Beta-band oscillations) associated with the return of voluntary behavior.\n\nImpact: By providing a real-time, objective measure of motor intention and execution, SeeMe aims to identify \"Cognitive-Motor Dissociation\" (CMD) earlier than current methods, facilitating more accurate prognostications and laying the framework for future closed-loop neuromodulation (e.g., Vagus Nerve Stimulation) to accelerate TBI recovery.",[89,27],"Traumatic Brain Injury (TBI) Patients",[54,91,92,93,94,95,96,97],"Disorders of Consciousness","Coma","Cognitive-Motor Dissociation","Covert Awareness","Computer Vision","Deep Learning","Artificial Intelligence","2026-04-30",{"date":100,"type":32},"2026-05-05",{"date":102,"type":32},"2026-03-30",{"date":104,"type":23},"2029-12",{"name":106,"class":38},"Stony Brook University",1,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":116,"targetDuration":4,"studyType":49,"phases":118,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"100507612","external-lumbar-drainage-to-reduce-icp-in-severe-tbi-a-phase-1-clinical-trial-100507612","NCT05889650","External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial","External Lumbar Drainage to Abort Severe Traumatic IntraCranial Hypertension: A Phase 1 Randomized, Allocation-concealed, Open-label, Safety and Feasibility Clinical Trial","ELASTIC","Inclusion Criteria:\n\n1. 18-65 years age\n2. Glasgow Coma Scale (GCS) 3-8\n3. Pupils symmetric and bilaterally reactive\n4. Midline shift ≤5mm at the level of foramen of Monro on admission or post-operative brain CT\n5. Patent (complete or partial) quadrigeminal cisterns on admission or post-operative brain CT\n6. First randomization and intervention may be commenced within 24 hours of injury\n7. ELD safety score ≥5\n\nExclusion Criteria:\n\n1. GCS \\>8\n2. Cisterns on CT completely effaced\n3. Midline shift on CT \\>5mm\n4. GCS 3 with dilated and fixed pupils\n5. Uncal or tonsillar herniation on admission or post-operative brain CT\n6. Temporal lobe contusions with effaced ipsilateral cisterns\n7. Penetrating TBI\n8. Primary hemicraniectomy\n9. Pregnancy\n10. Prisoners\n11. Patients previously lacking capacity to consent or refuse treatment, or with advanced directives to forego aggressive care\n12. Pre-existing conditions affecting functional status or life expectancy to less than 1 year\n13. Contra-indications for ELD placement: coagulopathy, use of anticoagulants or anti-thrombotics, thrombocytopenia \\\u003C50,000, or severe spinal deformity.\n14. posterior fossa hemorrhage",{"count":117,"type":23},30,[86],"The goal of this phase 1 randomized controlled safety and feasibility clinical trial are to determine the safety of external lumbar drainage (ELD) in select patients with severe Traumatic Brain Injury (TBI). The main questions it aims to answer are (i) if ELD is feasible and (ii) safe to perform in severe TBI patients who have radiological evidence of patent basal cisterns and midline shift \\\u003C5mm without increasing the risk of neurological worsening or cerebral herniation.\n\nAll participants will receive routine usual care. The study group will additionally have ELD for cerebrospinal fluid (CSF) drainage. A comparison will be made between the usual treatment plus ELD (interventional) groups, and the usual treatment (control) groups on incidence rate of neurological worsening or cerebral herniation events, and whether total hours with raised intracranial pressure (ICP) are different.",[27,121],"Intracranial Hypertension",[123,124,125,126],"Traumatic brain injury","intracranial pressure","intracranial hypertension","lumbar drainage","2026-04-20",{"date":129,"type":32},"2026-04-22",{"date":131,"type":32},"2024-06-24",{"date":133,"type":23},"2028-06-30",{"name":135,"class":38},"Brain Trauma Foundation",6,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":145,"targetDuration":147,"studyType":24,"phases":4,"briefSummary":148,"conditions":149,"keywords":153,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":107},"100623564","the-rebro-severe-traumatic-brain-injury-registry-100623564","NCT07398274","The Örebro Severe Traumatic Brain Injury Registry","The Örebro Severe Traumatic Brain Injury Registry (ÖrSBID): A Prospective Observational Cohort Study","ÖrSBID","Inclusion Criteria:\n\n* Age \\> 16 years\n* Severe traumatic brain injury or other severe brain injury requiring neurointensive or neurointermediate care\n* Admission to Örebro University Hospital\n\nExclusion Criteria:\n\n* Age \\\u003C 16 years \\\u003C 90 years\n* Non-survivable brain injury\n* Patients not requiring neurointensive or neurointermediate care\n* Declinced consent by patient or legal representative",{"count":146,"type":23},200,"12 Months","Traumatic brain injury and other severe brain injuries requiring neurointensive care are associated with high mortality, long-term disability and substantial societal burden. Despite advances in critical care, outcomes after severe brain injury remain difficult to predict and secondary brain injury plays a major role in determining prognosis.\n\nThe Örebro Severe Brain Injury Database (ÖrSBID) is a prospective observational registry that aims to systematically collect detailed clinical, physiological, imaging and biological data from adult patients with severe brain injury requiring care at the neurointesive care unit or neurointermediate care unit at Örebro University Hospital.\n\nThe purpose of the registry is to enable deep phenotyping of severe brain injury, improve understanding of secondary injury mechanisms, support outcome prediction and provide a platform for longitudinal follow-up and future research. No experimental interventions are performed as part of the study.",[27,150,151,152],"Severe Brain Injury","Ischemic Stroke","Intracerebral Hemorrhage",[154,155,156,157,158,159,160,161],"severe traumatic brain injury","severe brain injury","neurointensive care","neurocritical care","multimodal monitoring","biomarkers","longitudinal follow-up","multiomics","2026-02-04",{"date":164,"type":32},"2026-02-09",{"date":166,"type":23},"2026-02-08",{"date":168,"type":23},"2028-02-15",{"name":170,"class":171},"András Zoltán Buki","OTHER_GOV",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":49,"phases":182,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":205},"100615035","optimal-cerebral-perfusion-pressure-guided-therapy-assessment-of-target-effectiveness---ii-100615035","NCT07287358","Optimal Cerebral Perfusion Pressure Guided Therapy: Assessment of Target Effectiveness - II","CPPopt Guided Therapy: Assessment of Target Effectiveness - II","Cogitate II","Inclusion Criteria:\n\n* Adult (\\>18 years old)\n* Severe TBI requiring ICP-directed therapy for at least 24 hrs on the assessment of the recruiting intensive care team and\u002For attending neurosurgeon\n* Start randomization within 24 hrs after ICU admission.\n\nExclusion Criteria:\n\n* Known pregnancy\n* Moribund at presentation (e.g. bilaterally absent pupillary responses)\n* Patients with a primary decompressive craniectomy\n* Failure to get final written informed consent",{"count":181,"type":23},60,[86],"After severe traumatic brain injury, adequate blood flow to the brain is essential for recovery. This depends on arterial blood pressure, yet intensive care units apply fixed targets to all patients - treating every brain and patient the same. This study aims to change that. With new technology, 'optimal' blood pressure can be determined for each individual brain and treatment can be tailored accordingly. This personalized approach to neurocritical care has never been tested in a randomized controlled study before. If effective in showing reduced brain damage biomarkers, it will fundamentally transform brain injury treatment and dramatically improve recovery outcomes for patients worldwide.",[54,27,62,185],"Cerebral Perfusion Pressure",[187,188,189,190,191,192,193,154,194,195],"CPPopt","optimal cerebral perfusion pressure","pressure reactivity index","PRx","Intracranial pressure","cerebral perfusion pressure","traumatic brain injury","cogitate","cogitate-II","2025-12-31",{"date":198,"type":32},"2026-01-06",{"date":200,"type":23},"2026-05-01",{"date":202,"type":23},"2028-05-15",{"name":204,"class":38},"Maastricht University Medical Center",4,{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":214,"targetDuration":4,"studyType":49,"phases":216,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":232},"100605736","phase-2-valproic-acid-for-traumatic-brain-injury-trial-100605736","NCT07166393","Valproic AcId for Traumatic BRAin INjury Trial","Multi-institutional Phase 2\u002F3 Trial of Valproic Acid in Patients With Moderate to Severe Traumatic Brain Injury","VIBRANT","Inclusion Criteria:\n\n1. Male or female between the ages of 18 and 65 years.\n2. Body Mass Index between 18 kg\u002Fm2 and 35 kg\u002Fm2.\n3. Females must be surgically sterilized, postmenopausal, or have a negative urine pregnancy test.\n4. Moderate to severe TBI: Glasgow Coma Scale (GCS) 3-12.\n5. Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG3) criteria\n\nExclusion Criteria:\n\n1. Persons with known history of adverse reactions to VPA\n2. Persons with known history of hepatitis B or C or clinical history of hepatic dysfunction, pancreatitis, or renal insufficiency.\n3. Persons with a known history of thrombocytopenia.\n4. Persons with platelet count less than 100,000 per microliter of blood.\n5. Persons with 2nd or 3rd degree burns of any size and location.\n6. Female subjects who are pregnant or lactating.\n7. Persons who are currently incarcerated or are in police custody.\n8. Persons with inadequate venous access.\n9. Treatment cannot start within 120 minutes from the onset of injury\n10. Non-survivable injuries in the estimation of the attending trauma surgeon.\n11. Interfacility transfers\n12. The time of injury is unknown\n13. Patients in hemorrhagic shock with a systolic blood pressure of \\\u003C90 mmHg on initial evaluation.\n14. Persons with a known \"do not resuscitate\" order prior to randomization\n15. Persons with a research \"opt out\" bracelet\n16. Persons who are currently enrolled in another clinical trial.\n17. Greater than 90 minutes between the onset of injury and arrival to the hospital",{"count":215,"type":23},432,[51,217],"PHASE3","The long-term goal of the clinical trial is to develop effective, safe, and easily administered life-saving treatments for patients with moderate to severe traumatic brain injury (TBI).\n\nPatients with moderate to severe TBI will randomly receive either:\n\n1. Standard of care treatment and normal saline\n2. Standard of care treatment and one dose of valproic acid (VPA) at a lower dose or a higher dose",[220,27],"Moderate Traumatic Brain Injury (TBI)",[222],"TBI, traumatic brain injury, VPA, valproic acid","2025-09-16",{"date":225,"type":32},"2025-09-22",{"date":227,"type":23},"2026-05",{"date":229,"type":23},"2030-12",{"name":231,"class":38},"Northwestern University",8,{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":243,"conditions":244,"keywords":249,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":4},"100601819","development-and-validation-of-a-prognostic-model-for-neurocritical-patients-using-multimodal-brain-monitoring-100601819","NCT07115459","Development and Validation of a Prognostic Model for Neurocritical Patients Using Multimodal Brain Monitoring","Protocol for Developing and Validating a Multimodal Brain Monitoring-Based Prognostic Model for Neurocritical Patients: A Prospective, Observational, Multicenter Cohort Study","Inclusion Criteria:\n\n1. Aged 18-80 years, no gender restrictions.\n2. Diagnosed with acute brain injury (ABI), including one of the following: large cerebral infarction, supratentorial large-volume intracerebral hemorrhage, subarachnoid hemorrhage, or severe traumatic brain injury, with imaging evidence (CT or MRI) supporting the diagnosis.\n3. On ICU admission, Glasgow Coma Scale (GCS) eye response = 1 (no eye opening) and motor score ≤ 5 (does not follow commands); or within 48 hours, neurological deterioration with no eye opening and motor score reduced to ≤ 5 (total GCS score ≤ 8).\n4. Able to undergo continuous multimodal monitoring, with an expected ICU stay of ≥72 hours.\n5. Informed consent signed by the family or legal representative.\n\nExclusion Criteria:\n\n1. Confirmed brain death on admission or imaging showing irreversible brain herniation.\n2. Severe trauma unrelated to brain injury (e.g., multiple fractures, spinal cord injuries, or visceral rupture) that may interfere with brain function monitoring or outcome assessment.\n3. Pre-existing severe neurological disorders such as epilepsy, severe encephalopathy, or chronic intracranial conditions (e.g., brain tumors or hydrocephalus).\n4. Inability to perform multimodal monitoring due to technical issues (e.g., equipment failure or sensor installation problems).\n5. Predicted survival time \\\u003C24 hours after admission, or family members choose to withdraw treatment.\n6. Refusal to participate in the study by the patient or their legal representative.","80 Years",{"count":242,"type":23},167,"This study aims to develop and validate a prognostic model for neurocritical patients using multimodal brain monitoring data. By combining data from various monitoring techniques such as EEG, TCD, and NIRS, this model will help predict 90-day outcomes (awake, comatose, or deceased) and support personalized treatment decisions. The study is observational and involves no experimental interventions.",[245,56,246,247,248,27],"Acute Brain Injury Coma","Cerebral Infarction","Intracranial Hemorrhages","Subarachnoid Hemorrhage",[250,251],"Multimodal Brain Monitoring","Prognostic Model","2025-08-03",{"date":254,"type":32},"2025-08-11",{"date":256,"type":23},"2025-08-15",{"date":258,"type":23},"2026-11-15",{"name":260,"class":38},"Xiangya Hospital of Central South University",{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":18,"minAge":269,"maxAge":270,"enrollmentInfo":271,"targetDuration":4,"studyType":49,"phases":273,"briefSummary":274,"conditions":275,"keywords":276,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":293},"100482776","benchmark-evidence-led-by-latin-america-trial-of-intracranial-pressure---pediatrics-100482776","NCT05566431","Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics","Pediatric Severe Traumatic Brain Injury in Latin America - A Randomized Trial Comparing Two Management Protocols","BELA TRIPP","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form by the parent(s) or guardian(s)\n2. Non-penetrating TBI\n3. Admission to study hospital within 24 hours of injury\n4. Total GCS score ≤ 8 on admission or within first 48 hours after injury (measured using pediatric GCS 1 for children \\\u003C 2 years old and standard GCS for older children)\n5. Age 1 through 12 years\n6. Able to randomize:\n\n   * Within 24 hours of injury (for patients with GCS ≤ 8 on admission) OR\n   * Within 24 hours of deterioration (for patients deteriorating to GCS ≤ 8 within 48 hours of injury)\n\nExclusion Criteria:\n\n1. Motor GCS score of 6\n2. GCS of 3 with bilaterally fixed and dilated pupils\n3. Injury thought to be intentionally inflicted by a family member or caregiver.","1 Year","12 Years",{"count":272,"type":23},428,[86],"Narrative:\n\nWorldwide, traumatic brain injury (TBI) is a leading cause of death and disability among children and adolescents. The Investigators aim to test whether pediatric TBI treatment guided by invasive intracranial pressure monitoring produces better patient outcomes than care guided by a protocol without invasive monitoring. Study findings will inform clinical practice in treating pediatric severe TBI globally. Focused didactic and experience-based learning opportunities will increase the research capacity of pediatric intensivists in Latin America.",[27],[277,278,279,280,281,282,283],"sTBI","ICP monitoring","randomized controlled trial","TBI management","Latin America","pediatric","Phase III","2025-06-25",{"date":286,"type":32},"2025-06-27",{"date":288,"type":32},"2023-03-22",{"date":290,"type":23},"2028-01-31",{"name":292,"class":38},"University of Washington",11,{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":49,"phases":303,"briefSummary":304,"conditions":305,"keywords":309,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":107},"100559149","incidence-characteristics-and-evolution-of-cerebral-vasospasm-with-clinical-impact-in-moderate-to-severe-traumatic-brain-injury-complicated-by-subarachnoid-hemorrhage-at-martinique-university-hospital-100559149","NCT06560372","Incidence, Characteristics and Evolution of Cerebral Vasospasm With Clinical Impact in Moderate to Severe Traumatic Brain Injury Complicated by Subarachnoid Hemorrhage at Martinique University Hospital","VASO-TC","Inclusion Criteria:\n\n* Adult patient aged 18 or over,\n* Hospitalized at the Martinique University Hospital for the treatment or monitoring of a moderate or severe TBI (Glasgow Score less than or equal to 13 at initial treatment) presenting with SAH on the cerebral CT scan,\n* Patient if capable, or representative of the patient in case of incapacity, having been informed of the research, and having given free, informed and written consent,\n* After an emergency inclusion procedure if the patient's representative is initially unreachable and written agreement, informed within the first 48 hours of inclusion by the representative or the patient if his neurological condition allows it,\n* Be affiliated to a social security system.\n\nExclusion Criteria:\n\n* Pregnant woman,\n* Presence of an aneurysmal pathology known or diagnosed at initial treatment,\n* History of chronic kidney failure stage 4 (creatinine clearance measured less than 30ml\u002Fmin),\n* Imminent death of the patient,\n* Patient presenting criteria for non-admission to critical care (death expected within 48 hours, progressive fatal pathology with vital prognosis in less than 30 days, patient in palliative situation),\n* Known allergy to iodized contrast products,\n* Be placed under legal protection, guardianship or curatorship,\n* Patient or representative who refused to allow the patient to participate in the study.\n\nAdditional Exclusion Criteria after patient's inclusion:\n\n* Death of the patient expected within the first 48 hours,\n* Minor,\n* Release from hospitalization against medical advice,\n* Transfer to another establishment before the 13th day of treatment (outside the Martinique University Hospital),\n* Change of opinion of the patient's representative (after neurological recovery) regarding the patient's participation in research,\n* Withdrawal of consent to participate in the study being supported with refusal to use the data collected until withdrawal of participation,",{"count":302,"type":23},154,[86],"Context :\n\nModerate to severe head trauma with altered state of consciousness is an extremely common pathology (between 60 and 120 cases per 100 000 people per year depending on the country and age group), and is responsible for 30% of deaths by trauma. It is complicated in 30-60% of cases by subarachnoid hemorrhage (SAH), which makes it the leading cause of SAH. SAH and its complications are well described when the origin is aneurysmal, notably cerebral vasospasm (CV) because it promotes delayed cerebral ischemia with a major prognostic impact. This is why the screening and prevention of this vasospasm are well established in the literature and in practice, in the nosological context of aneurysmal SAH.\n\nResearch problem :\n\nHowever, when it comes to post-traumatic SAH, CV is a more maligned entity, with a much less detailed description. However, when we know the prognostic interest that it could have for patients, it seems legitimate to seek to define its physiopathological and epidemiological contours. On a prospective cohort of 290 subjects, Oertel et al. (2005) demonstrated, in head trauma patients, an incidence of approximately 40% of compatible signs with the recognized criteria of CV.\n\nTo date, the literature remains sparse on this subject.\n\nProposed study :\n\nIn view of the incomplete scientific literature, the study team wish to carry out a prospective epidemiological study in moderate to severe head trauma patients complicated by SAH and hospitalized at the Martinique University Hospital, with the aim of better characterizing the incidence of the occurrence, and evolution of CV with clinical impact in these patients.\n\nOne of the original aspects of the proposed study is the use of CT scan with perfusion sequence, which has shown its superiority to Transcranial Doppler. The other particularity is its prospective aspect and triggered by an alteration in the clinical state of the patient presenting a traumatic SAH, then directly linking the pathophysiology (cerebral ischemia) and the clinical impact. Thus, the diagnosis of traumatic CV will be made on a cerebral CT scan by the association of the 50% reduction in the caliber of one or more cerebral arteries and a perfusion defect in the perfusion sequence in a context of alteration of neurological clinical examination or deterioration of neurological monitoring parameters. Finally, few studies have monitored the evolution of these patients at 1 and 6 months after the initial event.\n\nHypothesis :\n\nThe research hypothesis is that in the population of moderate to severe head trauma patients hospitalized at the Martinique University Hospital, when a new neurological symptomatology or a deterioration in the state of consciousness occurs, it could be a post-truamatic CV in 15 to 20% of cases.\n\nIndeed, the rare studies find frequencies of radiologically confirmed CV in head trauma patients of around 30-45%, with low numbers of subjects, retrospective studies, or not correlated with the clinic and with the clinical and paraclinical data necessary for the positive diagnosis of this entity. The reported frequency of traumatic CV with clinical impact ranges between 15-20%.\n\nThe study team therefore expect an incidence of 15 to 20% of CV with clinical impact in patients with traumatic SAH in Martinique. CV could be responsible for sudden deterioration of the neurological state in patients suffering from traumatic SAH between the 3rd and 12th day inclusive of treatment (according to retrospective studies already carried out) and responsible for its specific morbidity linked to cerebral ischemia localized in the spasmed area manifested by a worsening of the neurological prognosis on the modified Rankin scale.",[306,307,308,27],"SAH (Subarachnoid Hemorrhage)","Cerebral Vasospasm","Moderate Traumatic Brain Injury",[306,307,310,311,312],"Moderate and severe Traumatic Brain Injury","CT scan","Cerebral perfusion","2025-03-26",{"date":315,"type":32},"2025-03-31",{"date":317,"type":32},"2024-11-06",{"date":319,"type":23},"2028-12-06",{"name":321,"class":38},"University Hospital Center of Martinique"]