Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT02210403
Status:
COMPLETED
Last Update Posted:
2023-03-28
First Post:
2014-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of tDCS on the Arm and Hand Function in 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'}]}, '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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04-18'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2014-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-27', 'studyFirstSubmitDate': '2014-07-24', 'studyFirstSubmitQcDate': '2014-08-04', 'lastUpdatePostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change of motor task performance', 'timeFrame': 'Change from baseline motor task performance on the 3rd intervention day, and change from baseline in motor task performance at 1 week post intervention'}], 'primaryOutcomes': [{'measure': 'Change of Fugl-Meyer assessment (FMA) score', 'timeFrame': 'Change from baseline in FMA score on the 3rd intervention day; change from baseline in FMA score at 1 week post intervention'}], 'secondaryOutcomes': [{'measure': 'Change of Modified Ashworth scale (MAS)', 'timeFrame': 'Change from baseline in MAS scale on the 3rd intervention day; change from baseline in MAS scale at 1 week post intervention'}]}, 'conditionsModule': {'conditions': ['Transcranial Direct Current Stimulation', 'Cerebrovascular Accident (CVA)']}, 'referencesModule': {'references': [{'pmid': '38716555', 'type': 'DERIVED', 'citation': 'Zhang X, Meesen R, Swinnen SP, Feys H, Woolley DG, Cheng HJ, Wenderoth N. Combining muscle-computer interface guided training with bihemispheric tDCS improves upper limb function in patients with chronic stroke. J Neurophysiol. 2024 Jun 1;131(6):1286-1298. doi: 10.1152/jn.00316.2023. Epub 2024 May 8.'}, {'pmid': '33175411', 'type': 'DERIVED', 'citation': 'Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether tDCS in combination with motor training can improve hand and arm function in stroke patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stroke patients onset \\> 6 months\n* First ever stroke\n* Decreased hand and arm function\n* Mini Mental State Examination (\\>24)\n\nExclusion Criteria:\n\n* Depression\n* Pregnancy\n* Alcohol abuse\n* Aneurysm clips\n* Pacemaker\n* Neurostimulator\n* Implemented defibrillator\n* Magnetically activated implant or device\n* implemented pump\n* Spinal cord simulator\n* Implemented hearing aid\n* Artificial or prosthetic limb\n* Metal parts in the body\n* Any external or internal metal\n* Artificial heart valve\n* Other implants\n* History of brain surgery\n* Migraine\n* Family history of Epilepsy'}, 'identificationModule': {'nctId': 'NCT02210403', 'briefTitle': 'The Influence of tDCS on the Arm and Hand Function in Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'orgStudyIdInfo': {'id': 'S54797'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Upper limb motor function training + tDCS', 'description': 'Bi-hemispheric tDCS with motor function training', 'interventionNames': ['Device: transcranial direct current stimulation (tDCS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'upper limb motor function training + sham tDCS', 'description': 'sham tDCS with motor function training', 'interventionNames': ['Device: transcranial direct current stimulation (tDCS)']}], 'interventions': [{'name': 'transcranial direct current stimulation (tDCS)', 'type': 'DEVICE', 'armGroupLabels': ['Upper limb motor function training + tDCS', 'upper limb motor function training + sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'K U Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}