Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-31 @ 9:47 AM
Study NCT ID:
NCT03486795
Status:
COMPLETED
Last Update Posted:
2019-09-20
First Post:
2018-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dual Site-Dual Channel Non-invasive Brain Stimulation for Motor Function in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-19', 'studyFirstSubmitDate': '2018-03-22', 'studyFirstSubmitQcDate': '2018-04-01', 'lastUpdatePostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in motor evoked potential', 'timeFrame': 'Baseline and after intervention (approximately 30 minutes)', 'description': 'measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle'}], 'secondaryOutcomes': [{'measure': 'Changes in sequential motor task', 'timeFrame': 'Baseline and after intervention (approximately 30 minutes)', 'description': 'measures motor functional and dexterity of hand'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transcranial direct current stimulation', 'motor function'], 'conditions': ['Healthy']}, '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 healthy subjects. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. All subjects will go through four conditions of transcranial direct current stimulation with for 30 minutes. Four conditions are 1) Dual stimulation: i) anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex, ii) anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area. 2) M1 stimulation: anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex; 3) PMC stimulation: anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area. 4) sham stimulation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy subjects with age over 19 years old\n\nExclusion Criteria:\n\n* history of disorders involving central nervous system\n* patients with severe medial or psychiatric disease'}, 'identificationModule': {'nctId': 'NCT03486795', 'briefTitle': 'Dual Site-Dual Channel Non-invasive Brain Stimulation for Motor Function in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Effect of Dual Site-Dual Channel Non-invasive Brain Stimulation for Recovery of Motor Function in Healthy Subjects', 'orgStudyIdInfo': {'id': '2017-08-124-C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dual stimulation', 'description': '1. anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex\n2. anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area', 'interventionNames': ['Device: M1 stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'M1 stimulation', 'description': 'anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex', 'interventionNames': ['Device: M1 stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'PMC stimulation', 'description': 'anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area', 'interventionNames': ['Device: PMC stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham stimulation', 'description': 'Sham stimulation', 'interventionNames': ['Device: Sham stimulation']}], 'interventions': [{'name': 'M1 stimulation', 'type': 'DEVICE', 'description': 'stimulating primary motor cortex with anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex', 'armGroupLabels': ['Dual stimulation', 'M1 stimulation']}, {'name': 'PMC stimulation', 'type': 'DEVICE', 'description': 'stimulating premotor cortex with anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area', 'armGroupLabels': ['PMC stimulation']}, {'name': 'Sham stimulation', 'type': 'DEVICE', 'description': 'sham stimulation over both primary motor cortex and premotor cortex', 'armGroupLabels': ['Sham 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'}}}}