Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-05 @ 3:04 AM
Study NCT ID:
NCT02628561
Status:
COMPLETED
Last Update Posted:
2016-04-05
First Post:
2015-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Direct Current Stimulation Associate to Constraint Induced Movement Therapy Over Premotor Cortex in Severe Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D002544', 'term': 'Cerebral Infarction'}], 'ancestors': [{'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'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}, {'id': 'D000098483', 'term': 'Constraint Induced Movement Therapy'}], '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': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-03', 'studyFirstSubmitDate': '2015-12-04', 'studyFirstSubmitQcDate': '2015-12-09', 'lastUpdatePostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Independence measured by Barthel Index', 'timeFrame': 'Change for functional independence at baseline and week 2'}], 'secondaryOutcomes': [{'measure': 'Spasticity (Modified Ashworth Scale)', 'timeFrame': 'Baseline and Week 2'}, {'measure': 'Muscle strength (Medical Research Council Scale)', 'timeFrame': 'Baseline and Week 2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke', 'Cerebrovascular Disorders', 'Cerebral Infarction']}, 'descriptionModule': {'briefSummary': 'The purpose is to compare the effects of tDCS and constraint induced movement therapy (CIMT) in the premotor cortex vs. primary motor cortex in severely subacute stroke survivors.', 'detailedDescription': 'Stroke survivors experience one or more movement-related impairments and activity limitations. In this sense, the premotor cortex (PMC) can be considered as an alternative locus for post-stroke rehabilitation. In relation to physical rehabilitation protocols, associate to neuromodulation, the investigators have chosen a standardized physical therapy protocol for this study, the Constraint Induced Movement Therapy (CIMT), which presents evidence of good therapeutic results. The investigators hypothesized that applying tDCS and CIMT over the PMC promotes motor restoration in stroke patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Diagnosis of unilateral, non-recurring, subacute stroke\n* Participants also had to be able, by using any method of pinch, to grasp a washcloth from a table top, lift it up a few inches, and release it.\n\nExclusion Criteria:\n\n* Patients with difficulty to follow the procedures or understand the instructions; cognitive deficits\n* tDCS criteria:\n\n * use of modulators of the Central Nervous System drugs\n * patients with implanted metallic or electronic devices\n * pacemaker\n * seizures\n * pregnancy\n * any other condition that might limit or interfere in the sensorimotor system'}, 'identificationModule': {'nctId': 'NCT02628561', 'briefTitle': 'Transcranial Direct Current Stimulation Associate to Constraint Induced Movement Therapy Over Premotor Cortex in Severe Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Paraíba'}, 'orgStudyIdInfo': {'id': 'tdcstroke'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active tdcs/M1', 'description': 'Anodal tDCS on primary motor cortex and CIMT (constraint induced movement therapy)', 'interventionNames': ['Device: Transcranial direct current stimulation', 'Behavioral: Constraint-Induced Movement Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Active tdcs/Premotor', 'description': 'Anodal tDCS on premotor cortex and CIMT (constraint induced movement therapy)', 'interventionNames': ['Device: Transcranial direct current stimulation', 'Behavioral: Constraint-Induced Movement Therapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tdcs', 'description': 'Sham tDCS and CIMT (constraint induced movement therapy)', 'interventionNames': ['Device: Transcranial direct current stimulation', 'Behavioral: Constraint-Induced Movement Therapy']}], 'interventions': [{'name': 'Transcranial direct current stimulation', 'type': 'DEVICE', 'armGroupLabels': ['Active tdcs/M1', 'Active tdcs/Premotor', 'Sham tdcs']}, {'name': 'Constraint-Induced Movement Therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Active tdcs/M1', 'Active tdcs/Premotor', 'Sham tdcs']}]}, 'contactsLocationsModule': {'locations': [{'city': 'João Pessoa', 'state': 'Paraíba', 'country': 'Brazil', 'facility': 'Suellen Andrade', 'geoPoint': {'lat': -7.115, 'lon': -34.86306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Paraíba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Suellen Marinho Andrade', 'investigatorAffiliation': 'Federal University of Paraíba'}}}}