[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"traumatic-brain-injuries\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:traumatic-brain-injuries":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,45,86,117,148,171,213,240,259,280,305],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100639950","recovery-trajectory-for-coma-and-disorders-of-consciousness-100639950",false,"NCT07614074","Recovery Trajectory for Coma and Disorders of Consciousness","Coma Cohort","Inclusion Criteria:\n\n* Age greater than or equal to 18 years on the day of hospital admission\n* Coma duration of at least 24 hours from presentation to the receiving hospital, or died prior to the 24 hour timepoint without return of consciousness. Coma defined as: GCS score of less than or equal to 10 AND GCS score of less than 6 on the motor component of the GCS(not following commands) AND GCS score less than 3 on the verbal component AND alteration of consciousness not explained by sedation only\n* Coma due to a neurological process (Including but not limited to: trauma, stroke, hypoxic- ischemic brain injury (HIBI), CNS infection, seizure, other processes at the discretion of the investigator)\n* Admission to the intensive care unit, or deceased prior to admission.\n\nExclusion Criteria:\n\n* Pre-existing score of 5 or less on the motor component of the Glasgow Coma Scale prior to hospital admission.\n* Transfer from another acute care hospital in which the motor component of the Glasgow Coma Scale on the day after initial hospital arrival is not known or cannot be reconstructed from medical records or history.\n* Coma due to sepsis, systemic metabolic processes (ex: organ failure or sedation).\n* GCS score of greater than 2 for eye opening with lack of command following due to a focal brain lesion causing receptive aphasia.\n* Prisoner","ALL","18 Years",{"count":19,"type":20},2000,"ESTIMATED","OBSERVATIONAL","This study aims to better understand recovery after coma caused by serious neurologic illness or injury. Patients who are unconscious (in a coma or disorder of consciousness) due to conditions such as stroke, cardiac arrest, traumatic brain injury, seizures, brain infection, or other neurologic emergencies may be enrolled during their hospitalization.\n\nThe purpose of this observational research study is to learn which medical, neurologic, psychological, and social factors are associated with recovery over time. Researchers will collect information from the medical record during hospitalization, including details about the patient's illness, treatments received, brain imaging, and neurologic examinations.\n\nFor patients who survive hospitalization, the study team will contact participants or their caregivers after discharge to assess recovery at scheduled time points using questionnaires and structured interviews about physical function, quality of life, emotional well-being, and daily activities.\n\nThis study does not assign participants to any experimental treatment. Participation will not change the medical care patients receive. Information learned from this study may help improve future care for patients with coma and disorders of consciousness.",[24,25,26,27,28,29,30,31],"Coma","Disorders of Consciousness","Cardiac Arrest (CA)","Traumatic Brain Injuries","Ischemic Stroke","Hemorrhagic Stroke, Intracerebral","Meningitis\u002FEncephalitis","Status Epilepticus","RECRUITING","2026-05-28",{"date":35,"type":36},"2026-06-02","ACTUAL",{"date":38,"type":36},"2023-09-26",{"date":40,"type":20},"2033-09",{"name":42,"class":43},"University of California, San Francisco","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":65,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":44},"100638098","pire-20-a-stepped-care-model-for-involving-relatives-across-sectors-100638098","NCT07590726","PIRe 2.0: A Stepped-Care Model for Involving Relatives Across Sectors","PIRe","Inclusion Criteria\n\n* Primary relative of an adult diagnosed with acquired brain injury (ABI) or malignant brain tumor (MBT), admitted to a participating hospital department.\n* Formally identified as the primary relative by the patient.\n* Aged ≥18 years.\n* Ability to read, understand, and complete questionnaires in Danish.\n\nExclusion Criteria\n\n* Insufficient proficiency in Danish to complete questionnaires and participate in structured conversations.\n* Concurrent participation in another interventional study with a similar aim that may interfere with the present study.",{"count":53,"type":20},160,"INTERVENTIONAL",[56],"NA","Serious brain diseases and injuries affect not only the person who becomes ill or injured, but also their family. Relatives of people with acquired brain injury (ABI) or malignant brain tumor (MBT) often take on a major role in daily care, decision-making, and coordination across healthcare services. This role can include managing information, supporting rehabilitation, and acting as a link between hospital care and community rehabilitation. Many relatives report high levels of stress, uncertainty, and emotional burden, especially during transitions between care settings.\n\nDespite recommendations for greater involvement of relatives, support for this group is often uneven and poorly coordinated across healthcare sectors. Relatives frequently experience lack of overview, limited guidance, and unclear expectations regarding their role. These challenges may increase caregiver burden and negatively affect both relatives' well-being and the continuity of care.\n\nThe PIRe 2.0 study aims to further test, and implement a structured intervention to support systematic involvement of relatives of people with ABI or MBT across hospital and community rehabilitation services. The intervention is designed as a \"caregiver compass\" that helps relatives understand their role, clarify their needs and wishes for involvement, and gain better overview of the care pathway.\n\nPIRe 2.0 is delivered through a stepped-care model, which allows the level of support to be adjusted over time based on each relative's level of burden and support needs. All relatives receive basic information and screening for caregiver burden using the 4-item Zarit Burden Interview (ZBI-4). Relatives who show signs of increased burden are offered additional support in steps, ranging from structured conversations with nurses to extended cross-sector coordination and specialized support for relatives with high or complex needs. Decisions about stepping up or down are based on both screening results and clinical assessment to ensure flexibility and person-centered care.\n\nThe study includes two groups of relatives: an intervention group receiving support through the PIRe stepped-care model, and a control group receiving usual care only. A total of 160 relatives will participate. Data are collected at baseline, at transitions between hospital and community care, and three to six months after the intervention.\n\nThe primary outcome is change in caregiver burden, measured with the Caregiver Burden Scale (CBS). Secondary outcomes include relatives' roles and responsibilities, perceived support and involvement in care, and mental well-being, assessed using validated patient-reported outcome measures.\n\nIn addition to evaluating the effect of the intervention, the study examines how the PIRe model can be implemented and sustained in everyday practice across healthcare sectors. The results are expected to show whether a structured, stepped-care approach can reduce caregiver burden, improve coordination between hospital and community services, and support more coherent and secure care pathways for people with ABI or malignant brain tumor and their relatives.",[59,60,61,27,62,63,64],"Brain Injuries, Acute","Brain Tumor Adult","Brain (Nervous System) Cancers","Glioblastom WHO Grade 4","Glioblastoma (GBM)","Stroke",[66,67,68,69,70,71,72,73,74,75],"Acquired brain injury","Malignant brain tumor","Relatives","Caregiver Burden","Involvement","Communication","Care transitions","Rehabilitation","Implementation","Stepped-care","NOT_YET_RECRUITING","2026-05-15",{"date":79,"type":36},"2026-05-19",{"date":81,"type":20},"2026-10-01",{"date":83,"type":20},"2029-09-30",{"name":85,"class":43},"Rigshospitalet, Denmark",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":54,"phases":95,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":44},"100572419","comparing-upper-limb-surgery-and-botulinum-toxin-for-spasticity-a-paired-design-study-100572419","NCT06733025","Comparing Upper Limb Surgery and Botulinum Toxin for Spasticity: A Paired Design Study","The Effectiveness of Spasticity-correcting Upper Limb Surgery Versus Botulinum Toxin Injections in Patients With Upper Limb Spasticity: an Experimental Study With Paired Design","Inclusion Criteria:\n\n1. 18 years or above\n2. Problematic spasticity, characterised by a velocity-dependent increase in tonic stretch reflexes or intermittent or sustained involuntary muscle activity in the UL after stroke, TBI, or SCI\n3. Patients treated at least 6 months after the injury event\n4. Ongoing BoNT treatment in the UL\n5. A minimum of 3 months passed since the last BoNT injection\n6. At least two muscles in the hand and wrist were considered for treatment\n7. For the BoNT group, a community occupational or physical therapist was assigned for post BoNT treatment\n8. For the surgery group, medically stable to undergo surgery\n9. No other severe UL injuries affecting the functional level\n\nExclusion Criteria:\n\n\\-",{"count":94,"type":20},30,[56],"Spasticity is a common complication following central nervous system injuries. Left untreated, spasticity can lead to various complications, hindering activities of daily living and diminishing independence. Spasticity affecting the hand is particularly debilitating because it prevents prehension and grasp, which are critical factors for the ability to perform activities of daily living independently. Spasticity is described as one of the prominent secondary conditions in individuals with various disabilities.\n\nWhile Botulinum toxin(BoNT) injections are widely used for focal spasticity, surgical interventions remain underutilized despite promising long-term outcomes. Center for Advanced Reconstruction of Extremities(C.A.R.E), at the hand surgery department at Sahlgrenska University hospital in Gothenburg, Sweden is a multiprofessional team and advocates a stratified surgical algorithm based on residual motor function, aiming to optimize patient outcomes.\n\nThis open-label, non-randomized, paired study aims to compare the efficacy of spasticity-correcting upper limb surgery with BoNT injections in improving body function, activity, and participation in patients with upper limb spasticity. A total of 30 patients will undergo both interventions sequentially, allowing for within-patient comparisons. The sample size calculation is based on prior studies.\n\nAll patients with ongoing BoNT treatment who get referral to C.A.R.E and seem eligible for the study will be informed about the study and enrolment procedure. Eligible participants will undergo both treatments sequentially, with outcome assessments conducted before and after each intervention. The treatments will follow routine clinical care.\n\nThe primary outcome measure, Modified Ashworth Scale, will assess spasticity severity. Secondary outcomes will include measures of functional and activity changes specific to each treatment regimen.\n\nThis study aims to provide valuable insights into the comparative effectiveness of spasticity interventions, guiding treatment decisions for patients with upper limb spasticity.",[98,99,64,27],"Muscle Spasticity","Spinal Cord Injury",[101,102,103,104,105,106],"Muscle spasticity","spinal cord injury","stroke","traumatic brain injuries","tendon lengthening","Botulinum toxin injection","2025-09-16",{"date":109,"type":36},"2025-09-17",{"date":111,"type":36},"2025-01-07",{"date":113,"type":20},"2029-06-29",{"name":115,"class":116},"Vastra Gotaland Region","OTHER_GOV",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":124,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":54,"phases":127,"briefSummary":128,"conditions":129,"keywords":132,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":147},"100582728","effectiveness-of-a-customized-digital-platform-to-increase-coordination-of-care-and-uptake-of-evidence-based-practices-100582728","NCT06867081","Effectiveness of a Customized Digital Platform to Increase Coordination of Care and Uptake of Evidence-based Practices","Effectiveness of a Customized Digital Platform to Increase Coordination of Care and Uptake of Evidence-based Practices: a Protocol for a Stepped-wedge Cluster Randomized Trial in Quebec","Inclusion Criteria:\n\nClinicians, coordinators, managers, working in the 8 participating programs.\n\nPatients and caregivers must be able to:\n\n* Provide informed consent to collect secondary outcomes (not needed for primary outcome, as identified administrative data will be provided by health regions)\n* Speak and read English or French.\n\nExclusion Criteria:\n\n* N\u002FA",true,{"count":126,"type":20},962,[56],"Background: Cardiovascular and neurological conditions are major causes of disability worldwide. Early, intensive rehabilitation is essential but often challenging to access in current healthcare systems. In Canada, the direct and indirect costs of acquired brain injury (ABI) are substantial, emphasizing the need for improved rehabilitation services. In collaboration with four health regions and the Canadian Foundation of Innovation (CFI) funded BRILLIANT research group, investigators are implementing a digital health platform (the BRILLIANT platform), which includes five modules to address current gaps and support a person-centered integrated care continuum for cardiovascular and neurological conditions. In this stepped wedge randomized trial, investigators plan to implement and evaluate the use of the BRILLIANT Platform for improving transitions of care in the rehabilitation of ABI individuals in Quebec.\n\nMethods: A stepped wedge cluster randomized trial will be conducted across four healthcare regions with eight programs. Eligible participants included new cardiovascular and neurological patients, caregivers, clinicians, coordinators, and managers. The BRILLIANT platform intervention, implemented in 2 phases, will provide standardized assessments, communication tools, shared intervention plans, self-management support, and quality improvement dashboards. Outcomes will include rehabilitation intensity measured in minutes, time from admission to rehabilitation, health-related quality of life, care experience, and costs. Data analysis will use mixed-effects models for quantitative data and content analysis for qualitative data.\n\nDiscussion: This study will provide valuable evidence on the effectiveness and feasibility of the BRILLIANT platform in improving rehabilitation care for patients with cardiovascular and neurological conditions in Quebec. Investigators anticipate that by addressing the challenges and pursuing future directions, the implementation of this digital platform can contribute to improving patient outcomes and healthcare delivery.",[130,27,64,131],"Aquired Brain Injury","Cardiovascular Diseases",[66,133,73,134,135,136,137],"Digital health platform","Transition of care","Person-centered care","Implementation science","stepped wedge trial","2025-08-22",{"date":140,"type":36},"2025-08-28",{"date":142,"type":20},"2025-09-30",{"date":144,"type":20},"2029-12",{"name":146,"class":43},"Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal",2,{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":4},"100602904","point-of-care-testing-in-emergency-departments-after-mild-traumatic-brain-injury-100602904","NCT07129577","Point of Care Testing in Emergency Departments After Mild Traumatic Brain Injury","Point of Care Testing in Emergency Departments After Mild Traumatic Brain Injury (POCkET)","POCkET","Inclusion Criteria:\n\n* Adult patients (≥ 18 years of age)\n* Glasgow Coma Score \\>12\n* Presentation within 24 hours of head injury\n* Meet criteria to be assessed using NICE NG232 clinical decision support tool (CDST).\n* Patients with a prior history of TBI may still be included.\n\nExclusion Criteria:\n\n* Participant without capacity and no available patient legal representative or professional consultee.\n* Participant with capacity unwilling to provide informed consent\n* Unable to adequately understand written and verbal English.\n* Prisoners currently in custody of HM Prison Service","100 Years",{"count":158,"type":20},400,"Traumatic brain injury (TBI) is estimated to have the highest incidence of all common neurological disorders, affecting 50 to 60 million people worldwide each year. In the UK, approximately one million people attend an Emergency Department (ED) annually following a head injury, and 80-90% of these are classified as mild TBI (mTBI), also referred to as concussion. In the acute setting, mTBI is typically defined by a Glasgow Coma Scale (GCS) score of 13-15 on presentation.\n\nCurrent acute management focuses primarily on identifying which patients require a CT head scan to detect life threatening injuries that may need neurosurgical intervention, observation, or neurocritical care. However, there is increasing recognition that the term \"mild\" can be misleading. Many patients, including those with normal CT scans,experience persistent functional, cognitive, and symptomatic deficits that may benefit from further intervention and follow-up care.\n\nBlood biomarkers offer significant potential to improve the early diagnosis, risk stratification, and prognostication of mTBI in the ED setting. While these biomarkers are increasingly being developed and evaluated in moderate and severe TBI, their clinical utility in mild TBI has not yet been definitively demonstrated.\n\nTo fully assess their potential value, it is essential to understand the current care pathways for mTBI in the ED, how they are implemented in practice, and where biomarker information could meaningfully enhance clinical decision making and improve patient outcomes.\n\nThe POCKET study will use a systems engineering approach, in combination with health economic evaluation, to assess the potential role and utility of point-of-care blood biomarkers in the management of mild TBI in UK emergency departments. This research will be conducted using the Abbott biomarker platform.",[161,27],"Injuries, Head","2025-08-12",{"date":164,"type":36},"2025-08-19",{"date":166,"type":20},"2025-09-01",{"date":168,"type":20},"2026-08-29",{"name":170,"class":43},"Cambridge University Hospitals NHS Foundation Trust",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":54,"phases":182,"briefSummary":184,"conditions":185,"keywords":188,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":212},"100598525","phase-4-early-post-traumatic-seizures-prevention-trial-e-pts-trial-100598525","NCT07072624","Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)","Assessing Phenytoin and Levetiracetam Efficacy, Cost-Effectiveness, and CYP2C9\u002FSV2A Polymorphism in Early Post-Traumatic Seizures: A Multicentric Prospective Randomized Trial","E-PTS","Inclusion Criteria:\n\n1. Patients of severe blunt TBI with GCS score less than 10.\n2. Patients with GCS of more than 10 in the presence of computed tomographic imaging findings consistent with brain injury: subarachnoid hemorrhage \\[SAH\\], subdural hematoma \\[SDH\\], epidural hematoma \\[EDH\\], intracerebral hemorrhage \\[ICH\\], or diffuse axonal injury \\[DAI\\], depressed skull fracture.\n3. Patients with penetrating injury.\n\nExclusion Criteria:\n\n1. Females of childbearing age with urine pregnancy test positive.\n2. Devastating brain injury with expected or confirmed brain death within 48 hours of hospital admission,\n3. Prehospital use of anticonvulsants\n4. Development of seizures before enrolment.","70 Years",{"count":181,"type":20},1260,[183],"PHASE4","Rationale\u002Fgaps in existing knowledge: The prophylaxis for post-traumatic seizures (PTS) remains controversial due to a lack of class I evidence. Investigators plan to conduct a high-quality, prospective, multicentric, randomized study regarding seizure prophylaxis in traumatic brain injury (TBI) with phenytoin, levetiracetam, and the placebo in three respective treatment groups, along with the effect of drug polymorphism on seizure occurrence.\n\nNovelty: Literature is scarce regarding the ideal management of early PTS in traumatic brain injury (TBI), a major public health problem. Further, no study has evaluated the effect of genetic polymorphism on seizure occurrence in traumatic brain injury. This Multicentric study will be the first of its kind, not only in India but also globally.\n\nObjectives: To evaluate the seizure incidence \\& efficacy of the respective anti-epileptic drug in each treatment arm. Assessment of clinical \\& functional outcomes, safety profile, and cost-effectiveness in each group. Effect of genetic polymorphisms on seizure incidence among study participants Methods: A Multicentric prospective randomized placebo-controlled double-blinded clinical trial is planned. After satisfying eligibility criteria and informed consent, TBI patients will be randomly allocated into three arms 'phenytoin arm', 'levetiracetam arm', and 'placebo'. Drug polymorphism will be analyzed in all the patients using quantitative real-time PCR.\n\nExpected outcome: This study will provide high-quality evidence in PTS management and will establish the role of prophylactic anti-epileptics in PTS. This study also opens the plethora of undesignated roles of genetic polymorphism in the efficacy and safety of levetiracetam and phenytoin in traumatic brain injury patients.",[186,27,187],"Seizures","Traumatic Brain Injury (TBI) Patients",[189,190,191,192,193,194,195,196,197,198,199,200,201,202],"Post Traumatic Seizures","Early Post Traumatic Seizures","Traumatic Brain Injury","Seizure Prophylaxis","Antiepileptic drugs","Phenytoin","Levetiracetam","Placebo","Genetic polymorphism","CYP2C9","SV2A","Randomized Controlled Trial","Cost-effectiveness","Multicentric Trial","2025-08-01",{"date":205,"type":36},"2025-08-06",{"date":207,"type":36},"2025-07-23",{"date":209,"type":20},"2028-03-15",{"name":211,"class":116},"All India Institute of Medical Sciences, Jodhpur",3,{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":179,"enrollmentInfo":221,"targetDuration":223,"studyType":21,"phases":4,"briefSummary":224,"conditions":225,"keywords":227,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":4},"100575771","effectiveness-of-surgical-procedures-for-acute-cranial-expansion-in-traumatic-brain-injury-100575771","NCT06776614","Effectiveness of Surgical Procedures for Acute Cranial Expansion in Traumatic Brain Injury","A Comparative-effectiveness Study on Expansion Craniotomy Versus Decompressive Craniectomy for Surgical Management of Traumatic Brain Injury in Patients With Intracranial Compartment Syndrome","E-SPACE-TBI","Inclusion Criteria:\n\n1. TBI patients arriving at the emergency room in the first 24 hours following trauma.\n2. Abnormal computed tomography (CT), with a primary injury including any epidural, intracerebral, or subdural collection with a midline shift \\>3mm and any basal cistern compression with at least 2 abnormal findings in the initial evaluation at the emergency room (including optic nerve ultrasound \\> 6mm at the same side of the CT´s primary injury or and\u002For an abnormal pupillometry with a reduced (Maximum Contraction Velocity) MCV in the pupil of the same side of the CT´s primary injury, or\u002Fand a Trans- Cranial Doppler (TCD) with Pulsatility Index (PI) \\> 1.3 and\u002For Middle Cerebral Artery - Diastolic Velocity (MCA-DV) \\\u003C 20cm\u002Fseg on the same side of the CT´s primary injury or\u002Fand an Intracranial Pressure Pulse Wave (ICPPW) ICPPW2 \\> ICPPW1 waveform pattern in the same side of the CT´s primary injury).\n3. Age 18 to 70 years old.\n4. Patients with or without polytrauma with survival expectancy \\>24 hours.\n5. Cranial decompression or cranial expansion surgical procedures less than 24 hours after the trauma.\n\nExclusion Criteria:\n\n1. TBI patients arriving at the emergency room after 24 hours following trauma.\n2. Normal CT scan at the emergency room.\n3. Abnormal CT scan at the emergency room with any primary injury and midline shift less than 3mm or without basal cistern compression and with normal values in at least two different modalities of assessing ICCS (pupillometry, optic nerve sheath ultrasound, transcranial Doppler and\u002For non-invasive ICP waveform analyzer).\n4. Age less than 18 or more than 70 years old.\n5. Polytrauma or massive brain injury with survival expectancy \\\u003C 24 hours.\n6. Cranial decompression or cranial expansion surgical procedures performed \\> 24 hours after the trauma.",{"count":222,"type":20},292,"24 Months","Traumatic brain injury (TBI) patients often exhibit an increase in their intracranial volume due to blood collection or brain tissue edema. When the volume of any intracranial compartment exceeds a critical threshold, the compensatory mechanisms become exhausted, compromising intracranial compliance and blood supply, which leads to intracranial compartment syndrome (ICCS). The presence of this condition exacerbates brain damage through secondary injury. When less invasive measures to counteract ICCS prove to be insufficient, cranial decompression is recommended, with decompressive craniectomy (DC) being the preferred technique.\n\nAlthough its effectiveness has been demonstrated, DC is also associated with an incidence of complications. Expansive craniotomy (EC) has been proposed as an alternative that can increase the benefits of cranial decompression provided by DC while reducing the associated complications. This observational study will compare the functional outcomes and complications of patients managed by DC and EC.",[27,226],"Intracranial Hypertension",[191,228,229,230],"Intracranial Compartment Syndrome","Decompressive Craniectomy","Expansive Craniotomy","2025-05-05",{"date":233,"type":36},"2025-05-08",{"date":235,"type":20},"2025-07-08",{"date":237,"type":20},"2027-12-31",{"name":239,"class":43},"Meditech Foundation",{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":179,"enrollmentInfo":248,"targetDuration":223,"studyType":21,"phases":4,"briefSummary":249,"conditions":250,"keywords":251,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":258,"locationsCount":4},"100575428","security-and-effectiveness-assessment-of-locking-systems-in-ventriculostomy-for-traumatic-brain-injury-100575428","NCT06772155","Security and Effectiveness Assessment of Locking Systems in Ventriculostomy for Traumatic Brain Injury","A Comparative Effectiveness Study on Catheter Locking Device Versus Standard Ventriculostomy for Surgical Management of Traumatic Brain Injury Patients With Intracranial Compartment Syndrome","SEALS-TBI","Inclusion Criteria:\n\n1. TBI patients arriving at the emergency room in the first 24 hours following trauma.\n2. Abnormal Computed Tomography (CT), with a primary injury including any epidural, intracerebral, or subdural collection with a midline shift \\>3 mm and any basal cistern compression with at least 2 abnormal findings in the initial evaluation at the emergency room (including optic nerve ultrasound \\> 6mm on the same side of the CT´s primary injury and\u002For an abnormal pupillometry with a reduced Maximum Contraction Velocity (MCV) in the pupil of the same side of the CT´s primary injury, or\u002Fand a Trans-Cranial Doppler (TCD) with Pulsatility Index (PI) \\> 1.3 and\u002For Medium Cerebral Artery - Diastolic Velocity (MCA-DV) \\\u003C 20cm\u002Fseg on the same side of the CT´s primary injury or\u002Fand an Intracranial Pressure Wave Form (ICPWF)2 \\> ICPWF1 waveform pattern on the same side of the CT´s primary injury).\n3. Age 18 to 70 years old.\n4. Patients with or without polytrauma with survival expectancy \\>24 hours.\n5. Ventriculostomy surgical procedures less than 24 hours after the trauma.\n\nExclusion Criteria:\n\n1. TBI patients arriving at the emergency room after 24 hours following trauma.\n2. Normal CT scan at the emergency room.\n3. Abnormal CT scan at the emergency room with any primary injury and midline shift less than 3mm or without basal cistern compression and with normal values in at least two different modalities of assessing ICCS (pupillometry, optic nerve sheath ultrasound, transcranial Doppler, and\u002For non-invasive ICP waveform analyzer).\n4. Age less than 18 or more than 70 years old.\n5. Polytrauma or massive brain injury with survival expectancy \\\u003C 24 hours.\n6. Ventriculostomy surgical procedures performed \\> 24 hours after the trauma.",{"count":222,"type":20},"This study aims to compare the effectiveness and safety of a standard intervention called ventriculostomy for managing increased intracranial pressure (ICP) in patients with severe traumatic brain injury (TBI). Elevated ICP is a critical condition that can result in brain damage or death if not treated promptly. The intervention will be performed in a traditional standard way or with an additional device called a catheter locking system. The first approach, standard ventriculostomy, involves placing a catheter into the brain's ventricular system to drain cerebrospinal fluid (CSF), thereby reducing ICP. The second approach incorporates the same catheter plus a catheter-locking device designed to secure the catheter in place, potentially reducing complications such as catheter displacement and the need for additional surgeries. Participants in this study will undergo either standard ventriculostomy or ventriculostomy with the locking device. Their progress will be observed during their hospital stay until the catheter is taken out (regularly on days 5th to 7th after the initial surgery) and assessed over one year through structured telephone follow-ups. The main outcomes include functional recovery, as measured by the Glasgow Outcome Scale Extended (GOSE), and the rate of complications such as operative site infections, catheter displacement, and\u002For reinterventions. By comparing these two methods, the study seeks to determine whether the locking device improves outcomes for TBI patients while maintaining or enhancing the safety and reliability of the procedure.",[27,226],[252,191,253],"External Ventricular Drain","Cranial Compartment Syndrome",{"date":233,"type":36},{"date":256,"type":20},"2025-07-05",{"date":237,"type":20},{"name":239,"class":43},{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":124,"sex":16,"minAge":17,"maxAge":266,"enrollmentInfo":267,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":269,"conditions":270,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":44},"100579899","validation-and-standardisation-of-a-neuralix-digital-ecological-battery-100579899","NCT06830291","Validation and Standardisation of a \"Neuralix\" Digital Ecological Battery","VANOLIX","Inclusion Criteria:\n\n* French-speaking subject aged 18 to 65 years old\n* Signed consent to participate\n* History of head trauma of moderate to severe intensity, i.e. having presented the high risk criteria of the study by Masters et al. (1987) at the time of the head trauma, and occurred a maximum of 5 years after inclusion in the VANOLIX study\n\nExclusion Criteria:\n\n* Visual or hearing or motor deficit disrupting the taking of cognitive tests\n* Subject with insufficient knowledge of counting (up to 25), the alphabet, reading, or French writing\n* Subject with a severe intellectual disability\n* Subject with past psychiatric or behavioral disorders requiring a stay \\>2 days in a specialized environment or requiring current treatment other than a single anxiolytic\n* Current treatment with antidepressant\n* Current treatment with antipsychotic or multiple anxiolytics\n* Single anxiolytic treatment initiated or increased for less than 1 month or current antiepileptic treatment\n* Subject with a neurological condition or a history leading to cerebral dysfunction likely to interfere with the cognitive assessment","65 Years",{"count":268,"type":20},800,"The management of head trauma patients requires the assessment of cognitive disorders using standardized neuropsychological tests and questionnaires. However, the evaluation tools currently available present well-identified limitations limiting the accuracy of the measurements (in a non-exhaustive manner, let us cite for example the absence of control of the rate of \"false positives\" or even the impossibility of measuring the improvement or decline in performance over time). In order to overcome these limitations, the Neuralix battery was created with particular attention to the assessment of memory and executive functions largely impacted after head trauma. The Neuralix battery comes in the form of a digital application accessible online and allowing a global assessment of cognitive functions in adults. In addition, the processing of results includes the operationalization of decision criteria taking into account the limitations cited above in order to improve the sensitivity of the evaluation.\n\nThe VANOLIX study proposes the validation of the Neuralix cognitive battery with head trauma patients of moderate to severe intensity as well as its standardization with healthy volunteers, these two steps being essential to making the tool available to clinician-researchers.",[27],"2025-04-29",{"date":273,"type":36},"2025-04-30",{"date":275,"type":36},"2025-03-11",{"date":277,"type":20},"2027-03",{"name":279,"class":43},"Direction Centrale du Service de Santé des Armées",{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":54,"phases":289,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":4},"100576053","phase-2-walking-with-overground-robotic-exoskeletons-to-improve-arrousal-in-individuals-with-disorders-of-consciousness-100576053","NCT06780280","Walking With Overground Robotic Exoskeletons to Improve Arrousal in Individuals With Disorders of Consciousness","ORE-DOC","Inclusion Criteria:\n\n* Individuals with DOC who are receiving inpatient rehabilitation\n\nExclusion Criteria:\n\n\\-",{"count":288,"type":20},25,[290,291],"PHASE2","PHASE3","This proposed study will examine a walking intervention to promote changes in conscious state in individuals with disorders of consciousness (DoC) due to acquired brain injury (ABI). Recent practice guidelines highlight the need to develop interventions to arouse patients with DoC, as current treatment options are scarce with limited to low-quality pharmaceutical and electrical stimulation approaches to improve outcomes. New data indicates patients with chronic DoC may benefit from therapeutic intervention prioritizing repeated multimodal sensory (i.e., simultaneous vestibular, proprioceptive, and visual) input, but likely not attain comparable functional recovery to those who demonstrate early command following ability. Interventions activating pathways of the cerebral consciousness network may leverage a substrate for recovery. We hypothesize that walking in an overground robotic exoskeleton (ORE) is safe, feasible, and will simultaneously stimulate endogenous cognitive and automatic pathways associated with walking5 to promote changes in behavioral performance in individuals with DoC.",[27],[295],"TBI, disorders of consciousness, walking, exoskeletons","2025-02-20",{"date":298,"type":36},"2025-02-24",{"date":300,"type":20},"2025-03-20",{"date":302,"type":20},"2026-01-30",{"name":304,"class":43},"Craig Hospital",{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":266,"enrollmentInfo":312,"targetDuration":4,"studyType":54,"phases":314,"briefSummary":315,"conditions":316,"keywords":317,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":328},"100448167","standard-craniectomy-against-laparotomy-for-the-treatment-of-traumatic-rise-in-intracranial-pressure-and-the-effect-on-long-term-outcome-100448167","NCT05115929","Standard Craniectomy Against Laparotomy for the Treatment of Traumatic Rise in Intracranial Pressure and the Effect on Long-term Outcome","SCALPEL","Inclusion Criteria:\n\n1. Age between 18 and 65 years\n2. Traumatic Brain Injury with abnormal CT scan\n3. Invasive ICP monitoring in place\n4. ICP \\>25 mmHg for 1-12h after conventional therapies step I and step II (see Trial flow chart)\n\nExclusion Criteria:\n\n1. Bilateral fixed and dilated pupil\n2. Limitation of therapies by the team due to poor prognosis\n3. Withdrawal of consent\n4. Severe pre-existing physical or mental disability or co-morbidity which would lead to a poor outcome even if the patient made a full recovery from the head injury\n5. Intracranial injury mandating craniotomy\u002Fcraniectomy in itself\n6. Intraabdominal injury mandating laparotomy in itself",{"count":313,"type":20},100,[56],"Intractable high intracranial pressures (ICP) are associated with poor functional outcomes and mortality, so the SCALPEL trials aims to evaluate the effect of decompressive craniectomy against decompressive laparotomy to lower those pressures in diffuse TBI. The primary outcome measure for that evaluation is functional outcome after 12 months on the extended Glasgow Outcome Scale (GOS-E).",[27],[27,229,318],"Decompressive Laparotomy","2023-05-14",{"date":321,"type":36},"2023-05-16",{"date":323,"type":36},"2022-10-01",{"date":325,"type":20},"2026-08",{"name":327,"class":43},"Technical University of Munich",4]