Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-23 @ 3:11 AM
Study NCT ID:
NCT02817867
Status:
COMPLETED
Last Update Posted:
2019-06-13
First Post:
2016-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Brain Stimulations for the Rehabilitation of Chronic 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'}, {'id': 'D050781', 'term': 'Transcranial Magnetic 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'}, {'id': 'D055909', 'term': 'Magnetic Field Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-12', 'studyFirstSubmitDate': '2016-06-27', 'studyFirstSubmitQcDate': '2016-06-27', 'lastUpdatePostDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor Function by means of the Wolf Motor Function Test', 'timeFrame': 'change from pre to post (at least 10 days)'}], 'secondaryOutcomes': [{'measure': 'Grip strength via hand dynamometer', 'timeFrame': 'change from pre to post (at least 10 days)'}, {'measure': 'Manual Dexterity by means of the Box and Block Test', 'timeFrame': 'change from pre to post (at least 10 days)'}, {'measure': 'Quality of Life by means of the Stroke Impact Scale', 'timeFrame': 'change from pre to post (at least 10 days)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': "Cerebrovascular accident (CVA) is a cerebrovascular disease with high incidence and morbidity in the Brazilian population, and is considered a major cause of disability in adults. Brain damage caused by stroke generates a maladaptive pattern of neural activity and modulation between the cerebral hemispheres, unbalancing in the inter-hemispheric inhibition. This condition affects patient's functional recovery.\n\nThe aim of this study is to verify the effectiveness of repetitive transcranial magnetic stimulation Association (rTMS) in the cortex motor contralesional, Transcranial Direct Current Stimulation (tDCS) in the motor cortex ipsilesional and the association between these two types of brain stimulations on the upper limb recovery after stroke."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subcortical stroke diagnosis, which has resulted in hemiparesis for at least 6 months and not more than 5 years (chronic condition);\n* Ability to reach 60 degrees in the shoulder flexion\n* Ability to completely extend the fingers in the affected upper limb;\n* Minimal cognitive ability to understand commands;\n* No current use of antiepileptic drugs for seizures.\n\nExclusion Criteria:\n\n* Painful shoulder, adhesive capsulitis or glenohumeral subluxation;\n* Contraindication (presence of metallic implants) or risks for the Transcranial magnetic stimulation, as evaluated by means of a standard questionnaire;'}, 'identificationModule': {'nctId': 'NCT02817867', 'briefTitle': 'Association Between Brain Stimulations for the Rehabilitation of Chronic Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Health Science of Porto Alegre'}, 'officialTitle': 'Association Between Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation for Chronic Stroke Patients Rehabilitation: a Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'APPG-2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'tDCS', 'description': 'Patients who will be treated with Transcranial direct-current stimulation (tDCS) in the ipsilesional motor cortex.', 'interventionNames': ['Device: tDCS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'rTMS', 'description': 'Patients who will be treated with Magnetic brain stimulation (rTMS) in the contralesional motor cortex.', 'interventionNames': ['Device: TMS']}, {'type': 'EXPERIMENTAL', 'label': 'tDCS + rTMS', 'description': 'Patients who will be treated with the association between Transcranial direct-current stimulation (tDCS) and magnetic brain stimulation (rTMS), in the ipsilesional and contralesional motor cortex, respectively.', 'interventionNames': ['Device: tDCS + TMS']}], 'interventions': [{'name': 'tDCS', 'type': 'DEVICE', 'description': 'Transcranial direct current stimulation (tDCS)', 'armGroupLabels': ['tDCS']}, {'name': 'TMS', 'type': 'DEVICE', 'description': 'Transcranial magnetic stimulation', 'armGroupLabels': ['rTMS']}, {'name': 'tDCS + TMS', 'type': 'DEVICE', 'description': 'Association between tDCS and TMS.', 'armGroupLabels': ['tDCS + rTMS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Federal University of Health Sciences of Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Health Science of Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Aline de Souza Pagnussat', 'investigatorAffiliation': 'Federal University of Health Science of Porto Alegre'}}}}