Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT03486769
Status:
COMPLETED
Last Update Posted:
2020-05-27
First Post:
2018-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dual Site-dual Channel Non-invasive Brain Stimulation for Motor Function in Stroke Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-25', 'studyFirstSubmitDate': '2018-03-22', 'studyFirstSubmitQcDate': '2018-04-01', 'lastUpdatePostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in motor evoked potentia', 'timeFrame': 'Baseline and after intervention (approximately 2 weeks)', 'description': 'measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle.'}], 'secondaryOutcomes': [{'measure': 'changes in nine hole peg test', 'timeFrame': 'Baseline and after intervention (approximately 2 weeks)', 'description': 'Nine-Hole Peg Test is used to measure finger dexterity in patients with various neurological diagnoses.'}, {'measure': 'changes in grip and tip pinch strength test', 'timeFrame': 'Baseline and after intervention (approximately 2 weeks)', 'description': 'measure the hand strength (grip and tip pinch)'}, {'measure': 'changes in box and block test', 'timeFrame': 'Baseline and after intervention (approximately 2 weeks)', 'description': 'box and block test measures unilateral gross manual dexterity'}, {'measure': 'Changes in brain activation of resting-state functional MRI', 'timeFrame': 'Baseline and after intervention (approximately 2 weeks)', 'description': 'Neuroplasticity measure'}, {'measure': 'Changes of Cortical activation', 'timeFrame': 'Baseline and after intervention (approximately 2 weeks)', 'description': 'Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transcranial direct current stimulation', 'dual stimulation'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of motor function in post stroke patients. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. All subjects will go through three conditions of transcranial direct current stimulation with for 30 minutes. Three conditions are 1) Dual stimulation 1: i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional premotor cortex and cathodal stimulation on contralesional supraorbital area. 2) Dual stimulation 2: i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional anterior intraparietal sulcus and cathodal stimulation on contralesional supraorbital area. 3) Single stimulation: anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral hemiplegic stroke patient\n* Fugl Meyer Assessment score between 9 to 84\n\nExclusion Criteria:\n\n* difficult to understand experimental tasks because of extremely severe cognitive impairment\n* history of psychiatric disease'}, 'identificationModule': {'nctId': 'NCT03486769', 'briefTitle': 'Dual Site-dual Channel Non-invasive Brain Stimulation for Motor Function in Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Effect of Dual Site-dual Channel Non-invasive Brain Stimulation for Recovery of Motor Function in Stroke Patients', 'orgStudyIdInfo': {'id': '2017-08-124-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dual Stimulation 1', 'description': 'i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional premotor cortex and cathodal stimulation on contralesional supraorbital area.', 'interventionNames': ['Device: M1 stimulation', 'Device: PMC stimulation', 'Behavioral: hand motor task']}, {'type': 'EXPERIMENTAL', 'label': 'Dual Stimulation 2', 'description': 'i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional anterior intraparietal sulcus and cathodal stimulation on contralesional supraorbital area.', 'interventionNames': ['Device: M1 stimulation', 'Device: aIPS stimulation', 'Behavioral: hand motor task']}, {'type': 'EXPERIMENTAL', 'label': 'Single stimulation', 'description': 'anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex', 'interventionNames': ['Device: M1 stimulation', 'Behavioral: hand motor task']}], 'interventions': [{'name': 'M1 stimulation', 'type': 'DEVICE', 'otherNames': ['primary motor cortex anodal stimulation'], 'description': 'stimulating primary motor cortex with anodal transcranial direct current stimulation', 'armGroupLabels': ['Dual Stimulation 1', 'Dual Stimulation 2', 'Single stimulation']}, {'name': 'PMC stimulation', 'type': 'DEVICE', 'otherNames': ['premotor cortex anodal stimulation'], 'description': 'stimulating premotor cortex with anodal transcranial direct current stimulation', 'armGroupLabels': ['Dual Stimulation 1']}, {'name': 'aIPS stimulation', 'type': 'DEVICE', 'description': 'stimulating anterior intraparietal sulcus with anodal transcranial direct current stimulation', 'armGroupLabels': ['Dual Stimulation 2']}, {'name': 'hand motor task', 'type': 'BEHAVIORAL', 'description': 'hand motor task for 30 minutes during transcranial direct current stimulation', 'armGroupLabels': ['Dual Stimulation 1', 'Dual Stimulation 2', 'Single stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}