Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-28 @ 8:19 AM
Study NCT ID:
NCT01034150
Status:
COMPLETED
Last Update Posted:
2009-12-17
First Post:
2009-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Home-based Neurostimulation Associated With Motor Training in 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-16', 'studyFirstSubmitDate': '2009-12-11', 'studyFirstSubmitQcDate': '2009-12-16', 'lastUpdatePostDateStruct': {'date': '2009-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the improvement in upper extremity performance assessed using Jebsen-Taylor test', 'timeFrame': 'Treatment lasted four weeks. Measures were performed before the treatment, immediately after the treatment and four months after the end of the treatment'}], 'secondaryOutcomes': [{'measure': 'Compliance with the interventions, assessed through a daily written log, and oral reports of the patients', 'timeFrame': 'immediately after the treatment'}, {'measure': 'Adverse events', 'timeFrame': 'at end of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Objective: To investigate effects of home-based somatosensory stimulation associated with motor training on improvement in performance of the paretic upper extremity in patients in the chronic phase after stroke.', 'detailedDescription': 'Design: Double-blind, randomized, controlled clinical trial. Setting: Home-based rehabilitation. Subjects: Patients in the chronic phase (\\> 6 months) after stroke. Interventions: Patients will be randomized to an active and a control group. In both groups, treatments will be performed at home, daily, over four weeks. Patients in the active group will be instructed to use a device that provides somatosensory stimulation in the form of electrical stimulation of the median nerve for two hours. Patients in the control group will also be instructed to use the device for two hours, and sham stimulation will be administered. In both groups, patients will be instructed to train activities with the paretic hand immediately after nerve stimulation.\n\nMain measures: The primary outcome will be improvement in performance of the paretic hand evaluated by the Jebsen-Taylor test at end of treatment and four months after end of treatment, compared to baseline. Secondary outcomes were: 1) Compliance with the interventions, assessed through a daily written log, and oral reports of the patients; 2) safety profile of the interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-80 years;\n* single ischemic or hemorrhagic stroke in a cerebral hemisphere, documented by computed tomography (CT) or magnetic resonance imaging (MRI);\n* stroke onset at least six months before;\n* hand paresis with preserved ability to perform all tasks of the Jebsen-Taylor Test (JTT).\n\nExclusion Criteria:\n\n* previous strokes;\n* epilepsy and other neurological conditions;\n* proprioceptive or tactile anesthesia;\n* shoulder or hand pain;\n* severe joint deformity;\n* severe chronic disease;\n* inability to give provide informed consent due to severe aphasia or cognitive impairment;\n* left handedness before the stroke.'}, 'identificationModule': {'nctId': 'NCT01034150', 'briefTitle': 'Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients', 'orgStudyIdInfo': {'id': '1309-06'}, 'secondaryIdInfos': [{'id': '477916/06-6', 'type': 'OTHER_GRANT', 'domain': 'CNPq'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Somatosensory stimulation', 'description': 'Active group', 'interventionNames': ['Device: Relief band (Somatosensory stimulation)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Placebo stimulation', 'interventionNames': ['Device: Placebo stimulation']}], 'interventions': [{'name': 'Relief band (Somatosensory stimulation)', 'type': 'DEVICE', 'otherNames': ['Relief band'], 'description': 'Electrical median nerve stimulation', 'armGroupLabels': ['Somatosensory stimulation']}, {'name': 'Placebo stimulation', 'type': 'DEVICE', 'otherNames': ['no stimulation'], 'description': 'Placebo stimulation', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'University of São Paulo/General Hospital', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Adriana Conforto, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital das Clínicas/FMUSP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}, {'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Adriana Bastos Conforto/ Staff neurologist, Hospital das Clinicas/University of Sao Paulo', 'oldOrganization': 'Hospital das Clinicas/University of Sao Paulo'}}}}