Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-02-03 @ 6:48 AM
Study NCT ID:
NCT02988206
Status:
COMPLETED
Last Update Posted:
2016-12-14
First Post:
2016-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Objects Can Improve the Diagnosis of EMCS From MCS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-12', 'studyFirstSubmitDate': '2016-12-05', 'studyFirstSubmitQcDate': '2016-12-08', 'lastUpdatePostDateStruct': {'date': '2016-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The frequency of behavioral response elicited by the stimuli suggested by CRS-R scale and the personalized stimuli they prefer', 'timeFrame': 'one week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Patients in Minimally Conscious State']}, 'referencesModule': {'references': [{'pmid': '29649978', 'type': 'DERIVED', 'citation': 'Sun Y, Wang J, Heine L, Huang W, Wang J, Hu N, Hu X, Fang X, Huang S, Laureys S, Di H. Personalized objects can optimize the diagnosis of EMCS in the assessment of functional object use in the CRS-R: a double blind, randomized clinical trial. BMC Neurol. 2018 Apr 12;18(1):38. doi: 10.1186/s12883-018-1040-5.'}]}, 'descriptionModule': {'briefSummary': "In this study，researchers will use personalized objects to assess patients' level of consciousness in chronic patients in minimally conscious state (MCS).", 'detailedDescription': 'The Coma Recovery Scale-Revised (CRS-R) is an important tool for the assessment of behaviors in DOC.Clinical practice has shown that self-referential stimuli, such as the patient\'s own name and face, are more effective to elicit the patient\'s response than that of non-self-referential stimuli.\n\nThe item "Functional Object Use" was assessed by using personalized objects (e.g., cigarette, paper) and non-personalized objects, which presented in a random order.The rest assessments were performed following the standard protocol of CRS-R. The differences between functional use of the two types of objects was analyzed by Chi-square test.\n\nResearchers expected to see some of the patients in MCS are re-diagnosed as EMCS with the using of personalized objects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients in minimally conscious state;\n* patients with stable condition;\n* each patient has athletic ability to some extent.\n\nExclusion Criteria:\n\n* premorbid neurology antecedent;\n* patients in coma or vegetative state;\n* patients \\< 1 months after the acute brain injury.'}, 'identificationModule': {'nctId': 'NCT02988206', 'briefTitle': 'Personalized Objects Can Improve the Diagnosis of EMCS From MCS', 'organization': {'class': 'OTHER', 'fullName': 'Hangzhou Normal University'}, 'orgStudyIdInfo': {'id': '2016R423055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Personalized Objects', 'description': 'The item "Functional Object Use" was assessed by using personalized objects (e.g., cigarette, paper) and non-personalized objects, which presented in a random order..', 'interventionNames': ['Behavioral: Personalized Objects', 'Behavioral: non-personalized Objects']}, {'type': 'OTHER', 'label': 'non-personalized objects', 'description': 'The item "Functional Object Use" was assessed by using non-personalized objects', 'interventionNames': ['Behavioral: non-personalized Objects']}], 'interventions': [{'name': 'Personalized Objects', 'type': 'BEHAVIORAL', 'description': 'personalized objects are based on the observation or the reports from family', 'armGroupLabels': ['Personalized Objects']}, {'name': 'non-personalized Objects', 'type': 'BEHAVIORAL', 'description': 'non-personalized objects are based on the suggestion in CRS-R,which are comb and cup', 'armGroupLabels': ['Personalized Objects', 'non-personalized objects']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hangzhou Normal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Undergraduate student', 'investigatorFullName': 'Yuxiao Sun', 'investigatorAffiliation': 'Hangzhou Normal University'}}}}