Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-25 @ 3:59 PM
Study NCT ID:
NCT01601392
Status:
UNKNOWN
Last Update Posted:
2012-05-18
First Post:
2012-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anodal and Cathodal Transcranial Direct Current Stimulation in Stroke Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic 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'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-16', 'studyFirstSubmitDate': '2012-05-11', 'studyFirstSubmitQcDate': '2012-05-16', 'lastUpdatePostDateStruct': {'date': '2012-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor power improvement', 'timeFrame': '3 Months', 'description': 'improvement in the motor power of paretic patient as measured in one proximal and one distal muscle group testing in upper (shoulder abduction + hand grip) and lower limbs ( hip flexion + toes dorsiflexion).'}], 'secondaryOutcomes': [{'measure': 'Motor cortical excitability', 'timeFrame': '1 Month', 'description': 'The difference in the motor cortical excitability (RMT, AMT) before and after tDCS'}]}, 'conditionsModule': {'keywords': ['Ischemic stroke', 'direct current stimulation', 'motor threshold', 'National institutes of Health Stroke Scale', 'Barthel index scale', 'Measurement of motor power improvement'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of this study will to compare the long-term effect of anodal versus cathodal transcranial direct current stimulation (tDCS) on motor recovery in subacute stroke patients. Forty patients with subacute ischemic stroke will randomly assigned to one of three groups: Anodal, Cathodal and Sham. Each group will receive tDCS at an intensity of 2mA for 25 minutes daily for 6 consecutive days over the affected (Anodal, Sham) or unaffected (Cathodal) motor cortex. Patients will be assessed with National Institutes of Health Stroke Scale (NIHSS), the Barthel index (BI) and the Medical Research Council (MRC) muscle strength scale at baseline, after end of the 6th tDCS session, and then 1, 2 and 3 months later. Motor cortical excitability will be measured at baseline and after the 6th session in both hemispheres.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute hemiparesis with single thromboembolic non-hemorrhagic infarction documented by magnetic resonance imaging (MRI)\n* Accept to participate in the study\n\nExclusion Criteria:\n\n* extensive infarction (taking all territories of middle cerebral artery)\n* severe flaccid hemiplegia\n* head injury\n* Any other neurological disease other than stroke\n* previous administration of tranquilizer\n* patients who are unable to give informed consent because of severe aphasia, or cognitive deficit.\n* Patients with no motor evoked response recorded from First Dorsal Interosseus (FDI) muscle of the affected hand'}, 'identificationModule': {'nctId': 'NCT01601392', 'acronym': 'tDCS', 'briefTitle': 'Anodal and Cathodal Transcranial Direct Current Stimulation in Stroke Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Anodal Versus Cathodal Transcranial Direct Current Stimulation on Stroke Recovery: a Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'tDCS in stroke recovery'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anodal tDCS', 'interventionNames': ['Procedure: transcranial direct current stimulation (Anodal)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cathodal tDCS', 'interventionNames': ['Procedure: transcranial direct current stimulation (Cathodal)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'interventionNames': ['Procedure: transcranial direct current stimulation (Sham)']}], 'interventions': [{'name': 'transcranial direct current stimulation (Anodal)', 'type': 'PROCEDURE', 'description': 'The anodal group will receive tDCS for 25 minutes at 2mA daily for 6 consecutive days on the affected hemisphere.', 'armGroupLabels': ['Anodal tDCS']}, {'name': 'transcranial direct current stimulation (Cathodal)', 'type': 'PROCEDURE', 'description': 'The Cathodal group will receive tDCS for 25 minutes at 2mA daily for 6 consecutive days on the unaffected hemisphere.', 'armGroupLabels': ['Cathodal tDCS']}, {'name': 'transcranial direct current stimulation (Sham)', 'type': 'PROCEDURE', 'description': 'The sham group will receive sham tDCS for 25 minutes daily for 6 consecutive days on the affected hemisphere.', 'armGroupLabels': ['Sham']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'state': 'Asyut Governorate', 'country': 'Egypt', 'facility': 'Faculty of Medicine, Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Eman M Khedr, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dina Hatem Elhammady', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Dina Hatem Elhammady', 'investigatorAffiliation': 'Assiut University'}}}}