Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-02 @ 8:13 PM
Study NCT ID:
NCT03185234
Status:
COMPLETED
Last Update Posted:
2022-05-20
First Post:
2017-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehabilitating (Stroke-induced) Apraxia With Direct Current Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D001072', 'term': 'Apraxias'}], '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': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-19', 'studyFirstSubmitDate': '2017-05-31', 'studyFirstSubmitQcDate': '2017-06-09', 'lastUpdatePostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'KAS (Cologne Apraxia Screening)', 'timeFrame': '3-4 days after stimulation', 'description': 'Degree of apraxia'}], 'secondaryOutcomes': [{'measure': 'KAS (Cologne Apraxia Screening)', 'timeFrame': '3 months after enrollment', 'description': 'Degree of apraxia'}, {'measure': 'Goldenberg Imitation', 'timeFrame': '3-4 days after stimulation, and 3 months after enrollment', 'description': 'Degree of apraxia'}, {'measure': 'de Renzi Imitation', 'timeFrame': '3-4 days after stimulation, and 3 months after enrollment', 'description': 'Degree of apraxia'}, {'measure': 'de Renzi actual tool use', 'timeFrame': '3-4 days after stimulation, and 3 months after enrollment', 'description': 'Degree of apraxia'}, {'measure': 'Action Research Arm Test (ARAT)', 'timeFrame': '3-4 days after stimulation, and 3 months after enrollment', 'description': 'Motor function'}, {'measure': 'Jebsen Taylor Hand Function Test (JTHFT)', 'timeFrame': '3-4 days after stimulation, and 3 months after enrollment', 'description': 'Motor function'}, {'measure': 'Gripforce (Vigorimeter)', 'timeFrame': '3-4 days after stimulation, and 3 months after enrollment', 'description': 'Motor function'}, {'measure': 'Strength of hands (MRC)', 'timeFrame': '3-4 days after stimulation, and 3 months after enrollment', 'description': 'Motor function'}, {'measure': 'National Institute of Health Stroke Scale (NIHSS)', 'timeFrame': 'enrollment', 'description': 'Impairment by stroke'}, {'measure': 'modified Ranking Scale (mRS)', 'timeFrame': '3-4 days after stimulation, and 3 months after enrollment', 'description': 'Impairment by stroke'}, {'measure': 'Aphasia Check List (ACL-K)', 'timeFrame': '3-4 days after stimulation, and 3 months after enrollment', 'description': 'Aphasia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tDCS'], 'conditions': ['Stroke', 'Apraxia']}, 'referencesModule': {'references': [{'pmid': '33324913', 'type': 'DERIVED', 'citation': 'Kleineberg NN, Richter MK, Becker I, Weiss PH, Fink GR. Verum versus sham tDCS in the treatment of stroke-induced apraxia: study protocol of the randomized controlled trial RAdiCS -"Rehabilitating (stroke-induced) Apraxia with direct Current Stimulation". Neurol Res Pract. 2020 Mar 4;2:7. doi: 10.1186/s42466-020-0052-y. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the clinical trial is to investigate whether weak transcranial direct current stimulation (tDCS) can ameliorate the motor cognitive deficit apraxia during stroke rehabilitation. Stroke patients with apraxia will either receive a real stimulation or a sham stimulation (placebo) for 10 minutes at a time on 5 consecutive days during their in-patient stay in a rehabilitation center. Additionally, motor tasks are performed before and after the stimulation. The effect of the weak current stimulation on motor function is assessed 3-4 days after the last stimulation and 3 months after enrollment.', 'detailedDescription': 'Despite the high incidence of the motor cognitive deficit apraxia after left-hemispheric stroke, evidence-based therapies do not exist. This randomized controlled clinical trial (RCT) investigates whether anodal transcranial direct current stimulation (tDCS) as an add-on therapy during neuro-rehabilitation can ameliorate apraxic deficits in patients with left hemisphere stroke. Therefore, anodal tDCS is applied over the parietal cortex of the left, lesioned hemisphere with an intensity of 2 mA for 10 minutes at a time on 5 consecutive days in combination with motor tasks before and after the stimulation. The effect of the stimulation is compared to a sham stimulation. Moreover, application of a pre-programmed study mode ensures a double-blind study design (patient and investigator). The performance in the apraxia test KAS (Cologne Apraxia Screening) 3-4 days after the last stimulation, compared to baseline, serves as primary endpoint of the study. Secondary endpoints are evaluated using various apraxia tests, motor tests and neuropsychological tests 3-4 days after the last stimulation and 3 months after enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* left hemispheric ischemic stroke in the subacute/ chronic phase (\\>10 days and \\<180 days post-stroke)\n* clinical confirmation of apraxia by KAS (Cologne Apraxia Screening), Cut-off ≤ 76/ 80 points;\n* age 18 - 90 years;\n* written Informed Consent\n\nExclusion Criteria:\n\n* pregnancy, breastfeeding and women without exclusion of pregnancy\n* patients with clinical manifestation of a stroke prior to the index-stroke\n* malignant disease with affection of central nervous system\n* life expectancy \\<12 months\n* current addiction to alcohol or drugs or other addictive disease (exception: nicotine)\n* current clinically manifest psychiatric disorders, such as schizophrenia or severe depressive episode\n* epileptic seizure within the past two years\n* continuous medication during the intervention phase with benzodiazepine, antipsychotics of high potential and anti-epileptic drugs taken for prophylaxis of epileptic seizures\n* enrollment in other studies with brain stimulation in the time period after the index stroke\n* heart pacemaker\n* electrodes for deep brain stimulation or other metal implants in the head (expected are dental fillings and inlays)\n* craniectomy or trepanation\n* vulnerable skin lesions at electrode positions\n* poor motivation/ cooperation'}, 'identificationModule': {'nctId': 'NCT03185234', 'acronym': 'RAdiCS', 'briefTitle': 'Rehabilitating (Stroke-induced) Apraxia With Direct Current Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'Therapeutischer Einsatz Der Schwachen Gleichstromstimulation (tDCS) Bei Motorisch-kognitiven Defiziten Nach Schlaganfall', 'orgStudyIdInfo': {'id': 'Uni-Koeln-3033'}, 'secondaryIdInfos': [{'id': 'U1111-1195-2536', 'type': 'OTHER', 'domain': 'WHO'}, {'id': 'DRKS00012292', 'type': 'REGISTRY', 'domain': 'DRKS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Real tDCS', 'description': 'Anodal tDCS at an intensity of 2 mA is applied for 10 minutes at a time on 5 consecutive days. The anodal electrode is placed over the left parietal cortex (P3 in 10/20 EEG) of the lesioned hemisphere, the cathodal electrode is located supraorbital on the right side. Motor tasks are performed before and after the stimulation.', 'interventionNames': ['Device: anodal tDCS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS', 'description': 'Sham stimulation is applied for 10 minutes at a time on 5 consecutive days. One electrode is placed over the left parietal cortex (P3 in 10/20 EEG) of the lesioned hemisphere and a second electrode supraorbital on the right side. Motor tasks are performed before and after the stimulation.', 'interventionNames': ['Device: sham tDCS']}], 'interventions': [{'name': 'anodal tDCS', 'type': 'DEVICE', 'otherNames': ['neuroConn DCS, model no. 008'], 'description': '2 mA, 10 min, 5 sessions', 'armGroupLabels': ['Real tDCS']}, {'name': 'sham tDCS', 'type': 'DEVICE', 'otherNames': ['neuroConn DCS, model no. 008'], 'description': 'sham stimulation, 10 min, 5 sessions', 'armGroupLabels': ['Sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53177', 'city': 'Bonn', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Rehabilitationszentrum Godeshöhe e.V.', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '45219', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'MediClin Fachklinik Rhein/Ruhr für Neurologie', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'overallOfficials': [{'name': 'Gereon R. Fink, Univ-Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Cologne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Univ.-Prof. Dr. med.', 'investigatorFullName': 'Gereon R. Fink', 'investigatorAffiliation': 'University of Cologne'}}}}