[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100396710":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":28,"locations":37,"responsibleParty":53,"collaborators":10,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":10,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":76,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"BDH-Klinik Hessisch Oldendorf","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ICU patients",null,"Patients with impaired consciousness admitted to intensive care unit after severe brain injury",[13],"Diagnostic Test: Coma-Recovery-Scale-Revised (CRS-R)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","Coma-Recovery-Scale-Revised (CRS-R)","CRS-R assessments (15 minutes) are repeated weekly after study entry",[9],[21,25],{"name":22,"affiliation":23,"role":24},"Jens D Rollnik, MD","BDH-Clinic Hessisch Oldendorf","STUDY_DIRECTOR",{"name":26,"affiliation":23,"role":27},"Melanie Boltzmann, PhD","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":10,"email":32},"CONTACT","0049 5152 781 256","m.boltzmann@bdh-klinik-hessisch.oldendorf",{"name":34,"role":30,"phone":35,"phoneExt":10,"email":36},"Simone B Schmidt, PhD","0049 5152 781 215","si.schmidt@bdh-klinik-hessisch.oldendorf",[38],{"facility":23,"status":39,"city":40,"state":10,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Hessisch Oldendorf","31840","Germany","DE",{"type":45,"coordinates":46},"Point",[47,48],9.24913,52.17269,{"lat":48,"lon":47},[51],{"name":26,"role":30,"phone":31,"phoneExt":10,"email":52},"m.boltzmann@bdh-klinik-hessisch-oldendorf.de",{"type":54,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100396710","prognostic-factors-to-regain-consciousness-100396710",false,"NCT04445649","Prognostic Factors to Regain Consciousness","Investigation of Prognostic Factors to Regain Consciousness in Neurological Early Rehabilitation","Inclusion Criteria:\n\n* early neurological rehabilitation (phase B)\n* stroke, traumatic brain injury, hypoxic-ischemic encephalopathy\n* disorder of consciousness (coma, UWS, MCS)\n* at minimum two weeks after disease onset\n* admission to intensive care unit\n* written consent from the patient's legal representative\n* exclusion of pregnancy\n\nExclusion Criteria:\n\n* insufficient cardiorespiratory stability\n* fractures or severe infratentorial brain injuries leading to impaired auditory evoked - potentials\n* previous brain damage\n* mental disorders (dementia, depression)\n* colonization with multi-resistant pathogens\n* MRI contraindications\n* claustrophobia\n* weight \\> 120 kg","ALL","18 Years","85 Years",{"count":66,"type":67},130,"ESTIMATED","OBSERVATIONAL","The study aims to identify factors that predict the medium and long-term outcome of patients with disorders of consciousness (DOC) undergoing early neurological rehabilitation.\n\nIn this prospective, observational study, 130 DOC patients are going to be included (36 months). At study entry, different routine data, disease severity and functional status are documented for each patient. In addition, MRI, EEG and evoked potentials are measured within the first week. The level of consciousness is recorded with the Coma-Recovery-Scale-Revised and serves as the primary outcome parameter. Complications, comorbidities, functional status and leve of consciousness are assessed weekly. After eight weeks, the measurement of the MRI, the EEG and the evoked potentials are repeated. After 3, 6 and 12 months, the Glasgow Outcome Scale-Revised is used to followed up the current status of the patients.",[71,72,73,74,75],"Neurologic Disorder","Disorder of Consciousness","Traumatic Brain Injury","Stroke","Hypoxic-Ischemic Encephalopathy",[77,78,79,80],"Neurological rehabilitation","Prognosis","Outcome","Level of consciousness","2025-09-18",{"date":83,"type":84},"2025-09-19","ACTUAL",{"date":86,"type":84},"2020-06-15",{"date":88,"type":67},"2027-12-15",{"name":5,"class":6},1]