Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT00407667
Status:
COMPLETED
Last Update Posted:
2011-03-21
First Post:
2006-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcranial Galvanic Stimulation After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010291', 'term': 'Paresis'}], '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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-11', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-18', 'studyFirstSubmitDate': '2006-12-01', 'studyFirstSubmitQcDate': '2006-12-01', 'lastUpdatePostDateStruct': {'date': '2011-03-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Upper Limb Motor Score (0-66)', 'timeFrame': '45 min'}], 'secondaryOutcomes': [{'measure': 'Box&Block Test', 'timeFrame': '5 min'}]}, 'conditionsModule': {'keywords': ['hemiparesis', 'rehabilitation', 'upper limb rehabilitation', 'arm therapy'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Transcranial galvanic stimulation (tDCS) seems to promote motor recovery after stroke by stimulating (anodal) or inhibiting (cathodal) neural circuits in the brain. In the treatment of severe arm paresis after stroke, robot-assisted arm training (AT) proved to be effective, but nevertheless only a few patients could use their affected hand functionally in daily life after robot training. Therefore the present study intends to combine both approaches, tDCS + AT, applied at the same time every day for six weeks. The study has three treatment arms, two groups will receive the tDCS, either anodal of the lesioned or cathodal of the non-lesioned hemisphere. The anodal stimulation is expected to facilitate the activity of the arm motor area of the lesioned side directly, while the cathodal stimulation of the non-lesioned hemisphere is expected to facilitate the lesioned side indirectly by decreasing inhibitory inputs. The third group will receive a sham-stimulation. All patients will work with the AT simultaneously to the tDCS, respectively sham-tDCS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subacute stroke\n* stroke interval 3 to 8 weeks\n* severe upper limb paresis\n* Fugl-Meyer \\< 18\n\nExclusion Criteria:\n\n* history of epilepsy\n* antiepileptic, neuroleptic medication\n* metal implants'}, 'identificationModule': {'nctId': 'NCT00407667', 'acronym': 'TraGAT', 'briefTitle': 'Transcranial Galvanic Stimulation After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Transcranial Direct Current Stimulation (tDCS) of the Lesioned or Non-lesioned Hemisphere Plus Computer-assisted Arm Trainer: a Randomized, Placebo-controlled Double-blind Multi-centre Study in Patients With Severe Arm Paresis Early After Stroke', 'orgStudyIdInfo': {'id': 'TraGAT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'patients receive 20 min of anodal transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track)', 'interventionNames': ['Device: transcranial galvanic stimulation']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'patients receive 20 min of cathodal transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track)', 'interventionNames': ['Device: transcranial galvanic stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': '3', 'description': 'patients receive 20 min of sham transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track)', 'interventionNames': ['Device: transcranial galvanic stimulation']}], 'interventions': [{'name': 'transcranial galvanic stimulation', 'type': 'DEVICE', 'description': 'for tDCS: Siemens Universal-Neuroton 826 for arm training: Bi-Manu-Track, Reha-Stim, Berlin', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13507', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité, University Medicine Berlin, Medical Park Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '09567', 'city': 'Kreischa', 'country': 'Germany', 'facility': 'Klinik Bavaria', 'geoPoint': {'lat': 50.94534, 'lon': 13.75514}}, {'zip': '3600', 'city': 'Bolzano', 'country': 'Italy', 'facility': 'Villa Melitta', 'geoPoint': {'lat': 46.49067, 'lon': 11.33982}}], 'overallOfficials': [{'name': 'Stefan Hesse, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité -University Medicine Berlin; Medical Park Berlin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'TraGAT', 'oldOrganization': 'Charité - University Medicine Berlin'}}}}