Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 12:28 AM
Study NCT ID:
NCT03492294
Status:
COMPLETED
Last Update Posted:
2018-04-10
First Post:
2018-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Music Stimulation in Disorders of Consciousness State: an fMRI Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018458', 'term': 'Persistent Vegetative State'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-03', 'studyFirstSubmitDate': '2018-04-03', 'studyFirstSubmitQcDate': '2018-04-03', 'lastUpdatePostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coma Recovery Scale-Revised', 'timeFrame': 'one to two years', 'description': 'examine the prognostic value of these patients, longitudinal behavioral assessments were repeatedly conducted by means of the CRS-R after fMRI acquisition'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['disorders of consciousness', 'music stimulation', 'functional magnetic resonance imaging'], 'conditions': ['Vegetative State', 'Minimally Conscious State']}, 'referencesModule': {'references': [{'pmid': '18591475', 'type': 'BACKGROUND', 'citation': 'Owen AM, Coleman MR. Detecting awareness in the vegetative state. Ann N Y Acad Sci. 2008;1129:130-8. doi: 10.1196/annals.1417.018.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to evaluated the neural effect of music on the cerebral activation in unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) by using functional magnetic resonance imaging (fMRI).', 'detailedDescription': 'Background: Sensory stimulations were used widely to evaluate the preserved cerebral functions for these patients with disorders of consciousness. Among these, the most alerting or common stimuli are probably familiar voice and music.\n\nObjective: The aim of the present study was to evaluated the neural effect of music on the cerebral activation in unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) by using functional magnetic resonance imaging (fMRI).\n\nMethods: Eleven severely brain-damaged patients (6 UWS and 5 MCS) were assessed by functional magnetic resonance imaging while they were exposed under the condition of their personal music. To examine the prognostic value of these patients, longitudinal behavioral assessments were repeatedly conducted by means of the CRS-R after fMRI acquisition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '61 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with disorders of consciousness', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18 years old;\n* no administration of neuromuscular blockers or sedation within the 24 hours of enrolment;\n* brain damage with eye opening (indicating wakefulness and rest cycles)\n\nExclusion Criteria:\n\n* Coma;\n* neurodegenerative disease;\n* psychiatric or neurologic illness;\n* with intracranial metal or other body metal.'}, 'identificationModule': {'nctId': 'NCT03492294', 'briefTitle': 'The Role of Music Stimulation in Disorders of Consciousness State: an fMRI Study', 'organization': {'class': 'OTHER', 'fullName': 'Hangzhou Normal University'}, 'officialTitle': 'The Role of Music Stimulation in Disorders of Consciousness State: an fMRI Study', 'orgStudyIdInfo': {'id': '2008W1224'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with disorders of consciousness', 'description': 'patients with disorders of consciousness from several brain injury have been clinically classified into coma, unresponsive wakefulness syndrome and minimally conscious state. These patients were scaned by functional magnetic resonance imaging.', 'interventionNames': ['Diagnostic Test: functional magnetic resonance imaging']}], 'interventions': [{'name': 'functional magnetic resonance imaging', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Coma Recovery Scale-Revised'], 'description': 'Patients with disorders of consciousness were assessed by functional magnetic resonance imaging while they were exposed under the condition of music.', 'armGroupLabels': ['patients with disorders of consciousness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3100036', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'International Vegetative State and Consciousness Science Institute, Hangzhou Normal University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Haibo Di, Pro', 'role': 'STUDY_CHAIR', 'affiliation': 'International Vegetative State and Consciousness Science Institute, Hangzhou Normal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hangzhou Normal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Jing Wang', 'investigatorAffiliation': 'Hangzhou Normal University'}}}}