Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-01-24 @ 6:40 PM
Study NCT ID:
NCT02525393
Status:
COMPLETED
Last Update Posted:
2015-08-17
First Post:
2015-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Stimulation in Motor Stroke Rehabilitation
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-13', 'studyFirstSubmitDate': '2015-08-11', 'studyFirstSubmitQcDate': '2015-08-13', 'lastUpdatePostDateStruct': {'date': '2015-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from the baseline ARAT (measures Grasp, Grip, Pinch, Gross Movement)', 'timeFrame': 'Baseline; 1 month; 3 months; 6 months; 6 months and 1 week; 7 months; 9 months; 12 months', 'description': 'Action Research Arm Test (ARAT) measures Grasp, Grip, Pinch, Gross Movement. Baseline is 1 week before first treatment; other time frame: 1 week after first treatment; 3 months after first treatment; 6 months follow-up after first treatment; 1 week before second treatment; 1 week after second treatment; 3 months follow-up after second treatment; 6 months follow-up after second treatment.'}], 'secondaryOutcomes': [{'measure': 'P300 (latency)', 'timeFrame': 'Baseline; 1 month; 6 months and 1 week; 7 months', 'description': 'The P300 (P3) wave is an event related potential (ERP) component elicited in the process of decision making.\n\nInvestigators measured the latency of the component 1 week before first treatment; 1 week after first treatment; 1 week before second treatment; 1 week after second treatment.'}, {'measure': 'Cognition (standardized neuropsychological assessment)', 'timeFrame': 'Baseline; 1 month; 6 months; 6 months and 1 week; 7 months; 12 months', 'description': 'The patients were evaluated by means of a standardized neuropsychological assessment consisting of a battery of cognitive tests involving the following domains: verbal short-term memory, visuospatial learning, working memory, verbal learning, attention and frontal executive functions, and general cognitive impairment.\n\nThe assessment was repeated 1 week before first treatment; 1 week after first treatment; 6 months follow-up after first treatment; 1 week before second treatment; 1 week after second treatment; 6 months follow-up after second treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rehabilitation', 'Non Invasive Brain Stimulation'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Patients were randomized in 3 groups: two intervent groups and a control group. The first group received two weeks of daily session of repetitive Transcranial Magnetic Stimulation (rTMS, 10 sessions) and, at least 6 months after, two weeks of daily transcranial Direct Current Stimulation (tDCS, 10 sessions); the second group received 10 daily session of tDCS and, after at least 6 months, 10 sessions of rTMS; the control group received 10 daily session of sham tDCS.\n\nPhysiatric evaluations (ARAT scale), neuropsychological assessment and ERP (P300) were performed before (1 week) and after (1 week) the end of each treatment. Furthermore, all patients underwent follow-up neuropsychological assessment 6 months after the end of each stimulation period and follow-up physiatric evaluation at 3 and 6 months after the end of each stimulation period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ischemic or hemorrhagic stroke (\\> 6 months from the accident)\n\nExclusion Criteria:\n\n* general cognitive impairment (Mini Mental State Examination \\< 25), severe functional disability (Barthel Index \\< 45),\n* psychiatric disorders,\n* degenerative neurological disorders,\n* epilepsy,\n* severe medical conditions,\n* having been implanted a drug infusion system, spinal/brain-stimulator, or endovascular coil'}, 'identificationModule': {'nctId': 'NCT02525393', 'briefTitle': 'Transcranial Stimulation in Motor Stroke Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'University of Turin, Italy'}, 'officialTitle': 'Safety and Efficacy of Non Invasive Transcranial Brain Stimulation in Motor Stroke Rehabilitation', 'orgStudyIdInfo': {'id': 'CEI 339'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tDCS+rTMS', 'description': 'Stroke patients were treated with an initial two weeks of transcranial direct current stimulation and after six months with two weeks of repetitive transcranial magnetic stimulation.', 'interventionNames': ['Device: tDCS', 'Device: rTMS']}, {'type': 'EXPERIMENTAL', 'label': 'rTMS+tDCS', 'description': 'Stroke patients were treated with an initial two weeks of repetitive transcranial magnetic stimulation and after six months with two weeks of transcranial direct current stimulation.', 'interventionNames': ['Device: tDCS', 'Device: rTMS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham stimulation', 'description': 'Stroke patients were treated with two weeks of sham transcranial direct current stimulation.', 'interventionNames': ['Device: Sham']}], 'interventions': [{'name': 'tDCS', 'type': 'DEVICE', 'otherNames': ['HDC Stim device Newronica'], 'description': 'Stroke rehabilitation performed with the aid of a transcranial electrical stimulation device.', 'armGroupLabels': ['rTMS+tDCS', 'tDCS+rTMS']}, {'name': 'rTMS', 'type': 'DEVICE', 'otherNames': ['PowerMAG 100 MAG&More'], 'description': 'Stroke rehabilitation performed with the aid of a repetitive transcranial magnetic stimulation device.', 'armGroupLabels': ['rTMS+tDCS', 'tDCS+rTMS']}, {'name': 'Sham', 'type': 'DEVICE', 'otherNames': ['HDC Stim device Newronica'], 'description': 'Stroke sham stimulation performed with the aid of a transcranial electrical stimulation device.', 'armGroupLabels': ['Sham stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Turin', 'country': 'Italy', 'facility': 'AOU Città della Salute e della Scienza', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}], 'overallOfficials': [{'name': "Federico D'Agata, PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Turin, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turin, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Federico Dagata', 'investigatorAffiliation': 'University of Turin, Italy'}}}}