[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628006":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":55,"collaborators":10,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":10,"enrollmentInfo":67,"targetDuration":10,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"BDH-Klinik Hessisch Oldendorf","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with Disorders of Consciousness",null,"Adult patients with severe acquired brain injury diagnosed with a disorder of consciousness (e.g., unresponsive wakefulness syndrome or minimally conscious state) undergoing structured behavioral assessment in a neurological rehabilitation setting.",[13,14],"Behavioral: Simplified Evaluation of CONsciousness Disorders (SECONDs)","Behavioral: Coma Recovery Scale-Revised (CRS-R)",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"BEHAVIORAL","Simplified Evaluation of CONsciousness Disorders (SECONDs)","The Simplified Evaluation of CONsciousness Disorders (SECONDs) is a structured behavioral assessment tool designed for the rapid evaluation of patients with disorders of consciousness.",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"Coma Recovery Scale-Revised (CRS-R)","The Coma Recovery Scale-Revised (CRS-R) is a standardized behavioral assessment tool used to evaluate the level of consciousness in patients with severe brain injury. It consists of six subscales assessing auditory, visual, motor, oromotor\u002Fverbal, communication, and arousal functions.",[9],[26],{"name":27,"affiliation":5,"role":28},"Melanie Boltzmann, PhD","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":10,"email":33},"CONTACT","+49 5152781256","m.boltzmann@bdh-klinik-hessisch-oldendorf.de",{"name":35,"role":31,"phone":36,"phoneExt":10,"email":37},"Simone B. Jenner","+49 5152781215","s.jenner@bdh-klinik-hessisch-oldendorf.de",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Hessisch Oldendorf","Lower Saxony","31840","Germany","DE",{"type":47,"coordinates":48},"Point",[49,50],9.24913,52.17269,{"lat":50,"lon":49},[53,54],{"name":27,"role":31,"phone":32,"phoneExt":10,"email":33},{"name":35,"role":31,"phone":36,"phoneExt":10,"email":37},{"type":56,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100628006","assessment-of-consciousness-with-crs-r-and-seconds-100628006",false,"NCT07456020","Assessment of Consciousness With CRS-R and SECONDs","Assessment of Consciousness After Severe Brain Injury: Comparison of CRS-R and SECONDs","AssessConsc","Inclusion Criteria:\n\n* Admission to an intensive care unit (ICU) or intermediate\u002Fhigh-dependency care unit\n* Underlying etiology of brain injury: anoxic, traumatic, or vascular\n* Time since index event \\\u003C 90 days\n* Early Rehabilitation Barthel Index (ERBI) score \\\u003C 30 points\n\nExclusion Criteria:\n\n* History of prior brain injury\n* Pre-existing major psychiatric disorder\n* Impaired language comprehension (e.g., insufficient German language proficiency or aphasia)\n* Ongoing sedation at the time of assessment\n* Interruption of rehabilitation treatment (transfer to an acute care hospital) for more than 14 days\n* isolation precautions due to multidrug-resistant organisms","ALL","18 Years",{"count":68,"type":69},110,"ESTIMATED","OBSERVATIONAL","Accurately determining the level of consciousness in patients with severe brain injury is essential for treatment planning, prognosis, and ethical decision-making. Clinically, levels of consciousness are differentiated into coma, Unresponsive Wakefulness Syndrome (UWS), and Minimally Conscious State (MCS) based on behavioral signs. Although behavioral assessment is considered the clinical gold standard, it is prone to misclassification. Research has shown that a substantial proportion of patients initially diagnosed with UWS may actually show signs of minimal consciousness, which is associated with better cognitive abilities and a more favorable prognosis.\n\nThe Coma Recovery Scale-Revised (CRS-R) is internationally recommended for diagnosing disorders of consciousness, but it is time-consuming and not free from diagnostic error. Repeated assessments can significantly improve diagnostic accuracy. To enhance feasibility in routine clinical practice, a shorter and more time-efficient assessment tool, the Simplified Evaluation of CONsciousness Disorders (SECONDs), was developed. This scale focuses on the behavioral signs most strongly associated with MCS and uses optimized testing procedures while maintaining high diagnostic accuracy.\n\nThe aim of this study is to further evaluate diagnostic approaches for assessing consciousness in patients with severe brain injury and to improve the reliability and clinical applicability of these assessments.",[73,74,75],"Disorders of Consciousness Due to Severe Brain Injury","Minimally Conscious State","Unresponsive Wakefulness Syndrome",[77,78,79,80,81,82],"Disorders of consciousness","Coma Recovery Scale-Revised","SECONDs","Acquired Brain Injury","Neurological rehabilitation","Critical ill patients","2026-03-09",{"date":85,"type":86},"2026-03-11","ACTUAL",{"date":88,"type":86},"2026-02-01",{"date":90,"type":69},"2028-03-31",{"name":5,"class":6},1]