Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-29 @ 11:00 AM
Study NCT ID:
NCT02987361
Status:
UNKNOWN
Last Update Posted:
2016-12-08
First Post:
2016-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of tDCS on Upper Extremity After Strokes
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-07', 'studyFirstSubmitDate': '2016-08-31', 'studyFirstSubmitQcDate': '2016-12-07', 'lastUpdatePostDateStruct': {'date': '2016-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Upper Motor Score change', 'timeFrame': 'before treatment, 48 hours after treatment, 4 weeks after treatment'}], 'secondaryOutcomes': [{'measure': 'Manual Muscle Test (MMT) change', 'timeFrame': 'before treatment, 48 hours after treatment, 4 weeks after treatment'}, {'measure': 'Range of Motion (ROM) change', 'timeFrame': 'before treatment, 48 hours after treatment, 4 weeks after treatment'}, {'measure': 'Korean version Modified Bathel Index (KMBI) change', 'timeFrame': 'before treatment, 48 hours after treatment, 4 weeks after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that transcranial direct current stimulation (tDCS) can improve upper limb motor recovery in the sub-acute phase of stroke patients.\n\nThis is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.', 'detailedDescription': 'The investigators hypothesize that transcranial direct current stimulation (tDCS) can improve upper limb motor recovery in the sub-acute phase of stroke patients.\n\nThis is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.\n\nInformed consent was obtained from all participants and procedures were conducted according to the Declaration of Helsinki. The protocol was approved by the Chonbuk National Uni. Hospital IRB, KOREA.\n\nSeventy-two stroke patients in the sub-acute phase will be recruited in three centers of neurorehabilitation in republic of Korea.\n\nPatients will be randomly divided to four groups; group1 is anodal stimulation on the lesioned primary motor cortex, group 2 is cathodal stimulation on the non-lesioned primary motor cortex, group 3 is dual stimulation such as anodal stimulation on the lesioned side and cathod stimulation on the non-lesioned side, and group 4 is shame stimulation group.\n\nThe stimulation will be conducted 2mA for 20 minute a day, 5 days per weeks, totally 2 weeks.\n\nFugl-Meyer upper motor score will be measured as a primary outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 20-85\n2. Unilateral Stroke patients\n3. Inclusion must be in the sub-acute phase defined as within 48hr-4 weeks after stroke\n4. Patients who have evoked motor potentials on the first dorsal interossei muscles on hemiplegic hand\n5. The patient has subscribed the informed consent\n\nExclusion Criteria:\n\n1. Insert a metal object on the head\n2. Convulsive disorders\n3. History of brain diseases other than stroke'}, 'identificationModule': {'nctId': 'NCT02987361', 'briefTitle': 'Effect of tDCS on Upper Extremity After Strokes', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University Hospital'}, 'officialTitle': 'Effects of Transcranial Direct Current Stimulation on Hemiplegic Upper Extremity Function After Strokes', 'orgStudyIdInfo': {'id': 'CBNUH_MDCTC_2015_tDCS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment group 1', 'description': 'anodal stimulation on the lesioned primary motor cortex DC-STIMULATOR PLUS', 'interventionNames': ['Device: DC-STIMULATOR PLUS']}, {'type': 'EXPERIMENTAL', 'label': 'treatment group 2', 'description': 'cathodal stimulation on the non-lesioned primary motor cortex DC-STIMULATOR PLUS', 'interventionNames': ['Device: DC-STIMULATOR PLUS']}, {'type': 'EXPERIMENTAL', 'label': 'treatment group 3', 'description': 'dual stimulation such as anodal stimulation on the lesioned side and cathodal stimulation on the non-lesioned side DC-STIMULATOR PLUS', 'interventionNames': ['Device: DC-STIMULATOR PLUS']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham group', 'description': 'sham group', 'interventionNames': ['Device: DC-STIMULATOR PLUS']}], 'interventions': [{'name': 'DC-STIMULATOR PLUS', 'type': 'DEVICE', 'otherNames': ['tDCS'], 'description': '2mA for 20minutes a day, 5 days per weeks, totally 2 weeks', 'armGroupLabels': ['sham group', 'treatment group 1', 'treatment group 2', 'treatment group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06355', 'city': 'Seoul', 'state': 'Ilwon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'AH HE LEE, MS', 'role': 'CONTACT', 'email': 'ahee.lee@gmail.com', 'phone': '82-2-6007-5408'}], 'facility': 'Kim Yeon Hee', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Min Jung YU, MANAGER', 'role': 'CONTACT', 'email': 'mjyu@mdctc.or.kr', 'phone': '82-63-259-3458', 'phoneExt': '3458'}, {'name': 'Myoung Hwan Ko, MD, PhD', 'role': 'CONTACT', 'email': 'mhko@jbnu.ac.kr', 'phone': '82-63-250-1795', 'phoneExt': '1795'}], 'overallOfficials': [{'name': 'Myoung Hwan Ko, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '634-18, Geumam-dong, Deokjin-gu, Jeonju, Jeonbuk, 561-712 Republic of Korea'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Samsung Medical Center', 'class': 'OTHER'}, {'name': 'Pusan National University Yangsan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Myoung Hwan Ko', 'investigatorAffiliation': 'Chonbuk National University Hospital'}}}}