Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-04-03 @ 12:39 PM
Study NCT ID:
NCT01865604
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2012-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of tDCS on Cerebral Autoregulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059345', 'term': 'Cerebral Small Vessel Diseases'}, {'id': 'D046589', 'term': 'CADASIL'}, {'id': 'D020325', 'term': 'Migraine with Aura'}], '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'}, {'id': 'D002544', 'term': 'Cerebral Infarction'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D015140', 'term': 'Dementia, Vascular'}, {'id': 'D002539', 'term': 'Cerebral Arterial Diseases'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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'}, {'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}]}, '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', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-15', 'studyFirstSubmitDate': '2012-12-18', 'studyFirstSubmitQcDate': '2013-05-28', 'lastUpdatePostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral vasomotor reactivity assessed by transcranial Dopplersonography', 'timeFrame': 'on 3 days within 12 weeks', 'description': 'comparing cerebral vasomotor reactivity at baseline and after anodal/cathodal/sham stimulation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cerebral Microangiopathy', 'CADASIL', 'Migraine With Aura', 'ICA Stenosis']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate whether there is a polarity-specific influence of tDCS on cerebral vasomotor reactivity monitored by transcranial doppler sonography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. severe cerebral Microangiopathy\n2. NOTCH3 carrier\n3. Migraine with aura (IHS Classification ICHD-II)\n4. Stenosis \\>80%, ECST-Criteria\n\nExclusion Criteria:\n\n* seizure disorder\n* history of severe alcohol or drug abuse, psychiatric illness like severe depression, poor motivational capacity\n* dementia\n\n(1+2) history of stroke in past 3 months (3) migraine prophylaxis (4) contralateral stenosis \\>50%,'}, 'identificationModule': {'nctId': 'NCT01865604', 'briefTitle': 'Impact of tDCS on Cerebral Autoregulation', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'orgStudyIdInfo': {'id': 'tDCS_cVMR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anodal tDCS', 'description': 'anaodal transcranial direct current stimulation', 'interventionNames': ['Device: Anodal tDCS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cathodal tDCS', 'description': 'cathodal transcranial direct current stimulation', 'interventionNames': ['Device: Cathodal tDCS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS', 'description': 'no stimulation', 'interventionNames': ['Device: sham tDCS']}], 'interventions': [{'name': 'Anodal tDCS', 'type': 'DEVICE', 'armGroupLabels': ['Anodal tDCS']}, {'name': 'Cathodal tDCS', 'type': 'DEVICE', 'armGroupLabels': ['Cathodal tDCS']}, {'name': 'sham tDCS', 'type': 'DEVICE', 'armGroupLabels': ['Sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Department of Neurology, Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Agnes Flöel, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Agnes Floeel', 'investigatorFullName': 'Agnes Flöel', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}