Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-01-04 @ 8:51 AM
Study NCT ID:
NCT02948660
Status:
COMPLETED
Last Update Posted:
2022-05-31
First Post:
2016-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Promising Tool for Predicting Consciousness Evolution in Prolonged Disorders of Consciousness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D018458', 'term': 'Persistent Vegetative State'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014474', 'term': 'Unconsciousness'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077334', 'term': 'Zolpidem'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2016-10-23', 'studyFirstSubmitQcDate': '2016-10-27', 'lastUpdatePostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Coma Recovery Scale-Revised', 'timeFrame': 'Six months after enrollment', 'description': 'The consciousness was independently assessed using CRS-R six months after enrollment by a trained neurologist blinded to the clinical data. Patients who transitioned from UWS to MCS (UWS-MCS) or to emergence from MCS (EMCS) (UWS-EMCS), from MCS minus to MCS plus (MCS--MCS+) or to EMCS (MCS--EMCS), and from MCS to EMCS (MCS-EMCS) were categorized in the improved consciousness group. The unimproved consciousness was defined as a reduced or unchanged level of consciousness at six months.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prolonged disorders of consciousness', 'Zolpidem', 'EEG', 'Prognosis', 'Unresponsive wakefulness syndrome', 'Minimally conscious state'], 'conditions': ['Disorder of Consciousness']}, 'descriptionModule': {'briefSummary': 'The research contains two parts. Part 1: To explore whether EEG responses to zolpidem can assess consciousness circuit integrity and predict the evolution of consciousness in patients with prolonged disorders of consciousness; Part 2: To explore if quantitative EEG reactivity might predict the prognosis of disorders of consciousness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* presence of unresponsive wakefulness syndrome (UWS) or minimally conscious state (MCS) on admission;\n* time since onset \\> 4 weeks;\n* no history of neurodegenerative or psychiatric diseases.\n\nExclusion Criteria:\n\n* allergic to zolpidem;\n* currently receiving zolpidem or related benzodiazepines;\n* diagnosed with seizure or status epilepticus.'}, 'identificationModule': {'nctId': 'NCT02948660', 'briefTitle': 'A Promising Tool for Predicting Consciousness Evolution in Prolonged Disorders of Consciousness', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'EEG Dynamics Induced by Zolpidem Forecasts Consciousness Evolution in Prolonged Disorders of Consciousness and Quantification of EEG Reactivity Predicts Recovery of Consciousness', 'orgStudyIdInfo': {'id': '81571262'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with prolonged disorders of consciousness', 'description': '1. age ≥ 18 years;\n2. presence of unresponsive wakefulness syndrome (UWS) or minimally conscious state (MCS) on admission;\n3. time since onset \\> 4 weeks;\n4. no history of neurodegenerative or psychiatric diseases.\n\nAll patients were administered 10 mg of zolpidem tartrate tablets via a feeding tube and received EEG-reactivity test.', 'interventionNames': ['Drug: Zolpidem Tartrate Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy volunteers', 'description': 'Healthy volunteers without any history of autonomic or any other nervous system disorder were included in this study. They were administered 10 mg of zolpidem tartrate tablets orally.', 'interventionNames': ['Drug: Zolpidem Tartrate Tablets']}], 'interventions': [{'name': 'Zolpidem Tartrate Tablets', 'type': 'DRUG', 'description': 'All participants were administered 10 mg of zolpidem tartrate tablets either via a feeding tube (for patients with prolonged disorders of consciousness) or orally.', 'armGroupLabels': ['Healthy volunteers', 'Patients with prolonged disorders of consciousness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Department of Neurology, Xijing Hospital, Fourth Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Wen Jiang, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Neurology, Xijing Hospital, Fourth Military Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guangzhou University of Chinese Medicine', 'class': 'OTHER'}, {'name': 'University of Melbourne', 'class': 'OTHER'}, {'name': 'Tianjin University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}