Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
Study NCT ID:
NCT00822068
Status:
UNKNOWN
Last Update Posted:
2009-01-14
First Post:
2009-01-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improvement of Language Disturbances After Stroke by Intensive Training and Electrical Brain Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001037', 'term': 'Aphasia'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D013064', 'term': 'Speech Disorders'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central 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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-01-13', 'studyFirstSubmitDate': '2009-01-13', 'studyFirstSubmitQcDate': '2009-01-13', 'lastUpdatePostDateStruct': {'date': '2009-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of words correctly named after training plus tDCS', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Communicative-Activity-Log & Stroke-and-Aphasia-Quality-of-Life-Scale', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stroke', 'aphasia', 'rehabilitation', 'transcranial direct current stimulation', 'intensive training', 'chronic aphasia after stroke'], 'conditions': ['Aphasia', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '21636820', 'type': 'DERIVED', 'citation': 'Floel A, Meinzer M, Kirstein R, Nijhof S, Deppe M, Knecht S, Breitenstein C. Short-term anomia training and electrical brain stimulation. Stroke. 2011 Jul;42(7):2065-7. doi: 10.1161/STROKEAHA.110.609032. Epub 2011 Jun 2.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to identify if intensive language training, consisting mainly of computer-based object naming, together with electrical brain stimulation, will lead to an improvement of language functions in patients that suffer from language disturbances after a stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic stroke (\\> 1 year after event)\n* aphasia due to stroke with naming impairment\n* German as first language\n* first-ever stroke\n\nExclusion Criteria:\n\n* more than 1 stroke\n* progressive stroke\n* history of severe alcohol or drug abuse, psychiatric illnessess like severe depression, poor motivational capacity\n* dementia\n* contraindications for Magnetic Resonance Imaging'}, 'identificationModule': {'nctId': 'NCT00822068', 'briefTitle': 'Improvement of Language Disturbances After Stroke by Intensive Training and Electrical Brain Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Improvement of Aphasia After Stroke by Intensive Training and Transcranial Direct Current Stimulation', 'orgStudyIdInfo': {'id': 'Aphasia_tDCS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'anodal tDCS', 'interventionNames': ['Device: anodal tDCS']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'cathodal tDCS', 'interventionNames': ['Device: cathodal tDCS']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'sham stimulation', 'interventionNames': ['Device: sham stimulation']}], 'interventions': [{'name': 'anodal tDCS', 'type': 'DEVICE', 'description': 'anodal transcranial direct current stimulation', 'armGroupLabels': ['anodal tDCS']}, {'name': 'cathodal tDCS', 'type': 'DEVICE', 'description': 'cathodal transcranial direct current stimulation', 'armGroupLabels': ['2']}, {'name': 'sham stimulation', 'type': 'DEVICE', 'description': 'sham stimulation', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48129/10098', 'city': 'Muenster / Berlin', 'state': 'NRW/Berlin-Brandenburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Agnes Floel, MD', 'role': 'CONTACT', 'email': 'floeel@uni-muenster.de', 'phone': '+49 251 83', 'phoneExt': '45699'}, {'name': 'Caterina Breiteinstein, PhD', 'role': 'CONTACT', 'email': 'breitens@uni-muenster.de'}, {'name': 'Agnes Floel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Neurology, University of Muenster; Department of Neurology, University of Berlin'}], 'centralContacts': [{'name': 'Agnes Floel, MD', 'role': 'CONTACT', 'email': 'floeel@uni-muenster.de', 'phone': '0049 251 83', 'phoneExt': '45699'}, {'name': 'Caterina Breitenstein, PhD', 'role': 'CONTACT', 'email': 'breitens@uni-muenster.de', 'phone': '0049 251 83', 'phoneExt': '49969'}], 'overallOfficials': [{'name': 'Agnes Floel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, University of Muenster; Department of Neurology, University of Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Department of Neurology', 'oldOrganization': 'University of Muenster'}}}}