Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-06-10 @ 7:44 AM
Study NCT ID:
NCT03243318
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2017-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motor Evoked Potential in the Affected Upper Limb Predicts the Potential of Motor Recovery in Subacute Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-21', 'studyFirstSubmitDate': '2017-08-04', 'studyFirstSubmitQcDate': '2017-08-07', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Action Research Arm Test', 'timeFrame': 'Change of Baseline Action Research Arm Test at 12 weeks post-stroke', 'description': 'Upper limb functional test'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Stroke, Subacute']}, 'descriptionModule': {'briefSummary': "Stroke is the third common cause of adult disability in dveloped countries. Early identification of the potential for motor recovery is important to avoid 'learned disuse' and to initiate appropriate therapy with achievable goals. The current cohort study focuses on those patients with SAFE \\<8 and using motor evoked potentials (MEPs) to improve on prognostication of upper limb motor recovery among subacute stroke patients in a local stroke population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subacute stroke patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First stroke with hemiparesis or hemiplegia with SAFE \\<8\n\nExclusion Criteria:\n\n* contra-indication to TMS or MRI, history of seizure, pregnancy and mentally unfit to understand the consent'}, 'identificationModule': {'nctId': 'NCT03243318', 'briefTitle': 'Motor Evoked Potential in the Affected Upper Limb Predicts the Potential of Motor Recovery in Subacute Stroke Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital Authority, Hong Kong'}, 'officialTitle': 'Motor Evoked Potential in the Affected Upper Limb Predicts the Potential of Motor Recovery in Subacute Stroke Patients', 'orgStudyIdInfo': {'id': 'KHMEPsUL2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Presence of motor evoked potentials', 'description': 'Those patients with Shoulder Abduction and Finger Extension (SAFE) score \\<8/10 with the presence of motor evoked potentials elicited by TMS over the ipsilesional motor cortex', 'interventionNames': ['Diagnostic Test: MEPs induced by TMS']}, {'label': 'absence of motor evoked potentials', 'description': 'Those patients with Shoulder Abduction and Finger Extension (SAFE) score \\<8/10 with the absence of motor evoked potentials elicited by TMS over the ipsilesional motor cortex', 'interventionNames': ['Diagnostic Test: MEPs induced by TMS']}], 'interventions': [{'name': 'MEPs induced by TMS', 'type': 'DIAGNOSTIC_TEST', 'description': 'Using TMS induced MEPs over motor cortex of the affected side to predict motor recovery potentials', 'armGroupLabels': ['Presence of motor evoked potentials', 'absence of motor evoked potentials']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Department of Rehabilitation, Kowloon Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Authority, Hong Kong', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Eric Man Pun Yeung', 'investigatorAffiliation': 'Hospital Authority, Hong Kong'}}}}