Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 12:05 AM
Study NCT ID:
NCT07456020
Status:
RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Consciousness With CRS-R and SECONDs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018458', 'term': 'Persistent Vegetative State'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement Between the "Simplified Evaluation of CONsciousness Disorders" (SECONDs; Range: 0-8) and the "Coma Recovery Scale-Revised" (CRS-R; Range: 0-23)', 'timeFrame': '6-8 days after admission to neurological rehabilitation', 'description': 'Categorical agreement in clinical classification of level of consciousness (Unresponsive Wakefulness Syndrome \\[UWS\\], Minimally Conscious State \\[MCS\\], Emerged from Minimally Conscious State \\[eMCS\\], No Disorder of Consciousness \\[non-DoC\\]) between the Simplified Evaluation of CONsciousness Disorders (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).'}], 'secondaryOutcomes': [{'measure': 'Diagnostic Stability in Patients Initially Classified as UWS', 'timeFrame': '6-8 days after admission to neurological rehabilitation', 'description': 'Rate of diagnostic reclassification following repeated behavioral assessment on two consecutive days in patients initially diagnosed with Unresponsive Wakefulness Syndrome (UWS). Misdiagnosis rate is defined as the proportion of patients whose level of consciousness is reclassified into a different diagnostic category (e.g., from UWS to Minimally Conscious State \\[MCS\\]) upon repeat measurement.'}, {'measure': 'Prognostic Validity of the "Simplified Evaluation of CONsciousness Disorders" (SECONDs; Range: 0-8) for Long-Term Functional Outcome', 'timeFrame': '12 months after admission.', 'description': 'Predictive value of baseline classification using the Simplified Evaluation of CONsciousness Disorders (SECONDs; ; Range: 0-8) for functional outcome at 12 months after admission, as measured by the Glasgow Outcome Scale-Extended (GOSE; Range: 1-8).'}, {'measure': 'Feasibility of the Simplified Evaluation of CONsciousness Disorders (SECONDs)', 'timeFrame': '6-8 days after admission to neurological rehabilitation', 'description': 'Assessment of clinical feasibility of SECONDs in a neurological rehabilitation setting, including test completion rate, administration time per assessment, and occurrence of premature test termination or technical/practical difficulties.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Disorders of consciousness', 'Coma Recovery Scale-Revised', 'SECONDs', 'Acquired Brain Injury', 'Neurological rehabilitation', 'Critical ill patients'], 'conditions': ['Disorders of Consciousness Due to Severe Brain Injury', 'Minimally Conscious State', 'Unresponsive Wakefulness Syndrome']}, 'referencesModule': {'references': [{'pmid': '28543735', 'type': 'BACKGROUND', 'citation': 'Wannez S, Heine L, Thonnard M, Gosseries O, Laureys S; Coma Science Group collaborators. The repetition of behavioral assessments in diagnosis of disorders of consciousness. Ann Neurol. 2017 Jun;81(6):883-889. doi: 10.1002/ana.24962.'}, {'pmid': '19622138', 'type': 'BACKGROUND', 'citation': 'Schnakers C, Vanhaudenhuyse A, Giacino J, Ventura M, Boly M, Majerus S, Moonen G, Laureys S. Diagnostic accuracy of the vegetative and minimally conscious state: clinical consensus versus standardized neurobehavioral assessment. BMC Neurol. 2009 Jul 21;9:35. doi: 10.1186/1471-2377-9-35.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This prospective observational study is designed to evaluate the clinical utility and diagnostic performance of the Simplified Evaluation of CONsciousness Disorders (SECONDs) in a neurological rehabilitation setting. The study aims to assess whether the implementation of SECONDs improves diagnostic accuracy in patients with disorders of consciousness during the subacute phase after severe acquired brain injury.\n\nParticipants will undergo structured behavioral assessment using SECONDs as part of the study protocol. Diagnostic classifications derived from SECONDs will be analyzed with regard to their internal consistency and clinical plausibility within the rehabilitation context.\n\nTo examine prognostic validity, functional outcome will be assessed 12 months after the initial evaluation. Follow-up data will be collected through structured telephone interviews with relatives or legal representatives. Functional status will be systematically documented in order to determine the predictive value of SECONDs classifications for long-term clinically relevant outcomes.\n\nThe study seeks to contribute to optimizing diagnostic procedures in disorders of consciousness and to strengthen the evidence base for time-efficient behavioral assessment tools in routine neurorehabilitation practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of adult patients with severe acquired brain injury admitted to a neurological early rehabilitation program. Eligible participants present with a disorder of consciousness in the subacute phase (within 90 days after the index event) and require intensive or monitored medical care. Underlying etiologies include anoxic, traumatic, or vascular brain injury. Patients are characterized by severe functional impairment, as reflected by a low Early Rehabilitation Barthel Index score at admission.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission to an intensive care unit (ICU) or intermediate/high-dependency care unit\n* Underlying etiology of brain injury: anoxic, traumatic, or vascular\n* Time since index event \\< 90 days\n* Early Rehabilitation Barthel Index (ERBI) score \\< 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'}, 'identificationModule': {'nctId': 'NCT07456020', 'acronym': 'AssessConsc', 'briefTitle': 'Assessment of Consciousness With CRS-R and SECONDs', 'organization': {'class': 'OTHER', 'fullName': 'BDH-Klinik Hessisch Oldendorf'}, 'officialTitle': 'Assessment of Consciousness After Severe Brain Injury: Comparison of CRS-R and SECONDs', 'orgStudyIdInfo': {'id': '12079-BO-S-2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Disorders of Consciousness', 'description': '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.', 'interventionNames': ['Behavioral: Simplified Evaluation of CONsciousness Disorders (SECONDs)', 'Behavioral: Coma Recovery Scale-Revised (CRS-R)']}], 'interventions': [{'name': 'Simplified Evaluation of CONsciousness Disorders (SECONDs)', 'type': 'BEHAVIORAL', 'description': 'The Simplified Evaluation of CONsciousness Disorders (SECONDs) is a structured behavioral assessment tool designed for the rapid evaluation of patients with disorders of consciousness.', 'armGroupLabels': ['Patients with Disorders of Consciousness']}, {'name': 'Coma Recovery Scale-Revised (CRS-R)', 'type': 'BEHAVIORAL', 'description': '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/verbal, communication, and arousal functions.', 'armGroupLabels': ['Patients with Disorders of Consciousness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31840', 'city': 'Hessisch Oldendorf', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Melanie Boltzmann, PhD', 'role': 'CONTACT', 'email': 'm.boltzmann@bdh-klinik-hessisch-oldendorf.de', 'phone': '+49 5152781256'}, {'name': 'Simone B. Jenner', 'role': 'CONTACT', 'email': 's.jenner@bdh-klinik-hessisch-oldendorf.de', 'phone': '+49 5152781215'}], 'facility': 'BDH-Klinik Hessisch Oldendorf', 'geoPoint': {'lat': 52.17269, 'lon': 9.24913}}], 'centralContacts': [{'name': 'Melanie Boltzmann, PhD', 'role': 'CONTACT', 'email': 'm.boltzmann@bdh-klinik-hessisch-oldendorf.de', 'phone': '+49 5152781256'}, {'name': 'Simone B. Jenner', 'role': 'CONTACT', 'email': 's.jenner@bdh-klinik-hessisch-oldendorf.de', 'phone': '+49 5152781215'}], 'overallOfficials': [{'name': 'Melanie Boltzmann, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BDH-Klinik Hessisch Oldendorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BDH-Klinik Hessisch Oldendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}