Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-02-22 @ 3:55 PM
Study NCT ID:
NCT03712150
Status:
COMPLETED
Last Update Posted:
2019-11-07
First Post:
2018-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Gene Polymorphism After Transcranial Cranial Direct Current Stimulation on the Corticobulbar Excitability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA of gene polymorphism from the Polymorphisms in brain-derived neurotrophic factor'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-05', 'studyFirstSubmitDate': '2018-10-10', 'studyFirstSubmitQcDate': '2018-10-17', 'lastUpdatePostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain corticobulbar excitability', 'timeFrame': 'Immediately after single conditioning the brain', 'description': 'Change of Brain corticobulbar excitability by motor evoked potentials'}], 'secondaryOutcomes': [{'measure': 'Tongue pressure measurement-', 'timeFrame': 'Immediate after single conditioning the brain', 'description': 'Change of tongue pressure measurement by Intra oral pressure assessment'}, {'measure': 'Electrophysiological responses of swallowing -', 'timeFrame': 'Immediate after single conditioning the brain', 'description': 'Change of Electrophysiological responses of swallowing - With the use of a laryngeal transducer, will measure the mylohyoid amplitude'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study aims to examine the effects of transcranial direct current stimulation at corticobulbar excitability in individuals with different gene polymorphism.', 'detailedDescription': 'The effects of TDCS on corticobulbar excitability of the brain after inhibitory pre-conditioning will be compared in patients with different BDNF phenotypes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy young volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19-40 years\n* Informed consent\n\nExclusion Criteria:\n\n* History of epilepsy\n* Presence of cardiac pacemaker\n* previous brain surgery\n* previous swallowing problems\n* current use of medication which acts on the central nervous system\n* presence of implanted metal intracranially'}, 'identificationModule': {'nctId': 'NCT03712150', 'briefTitle': 'Effects of Gene Polymorphism After Transcranial Cranial Direct Current Stimulation on the Corticobulbar Excitability', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'Role of Genetic Polymorphism in Neuroplasticity Involved in Dysphagia Recovery- Part 2', 'orgStudyIdInfo': {'id': 'HC18TNSV0061'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy', 'description': 'Healthy adults\n\n\\- Participants will receive single session of tdcs after application', 'interventionNames': ['Device: tdcs']}], 'interventions': [{'name': 'tdcs', 'type': 'DEVICE', 'description': 'application of optimised parameters of tDCS (anodal stimulation, 1.5 mA, 10 min) over the unconditioned hemisphere reverses the brain and behavioural consequences of inhibitory pre-conditioning', 'armGroupLabels': ['Healthy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucheon-si', 'state': 'Bucheonshi', 'country': 'South Korea', 'facility': 'Department of Rehabilitation Medicine', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Bucheon-si', 'state': 'Kyounggido', 'country': 'South Korea', 'facility': "Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine", 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}], 'overallOfficials': [{'name': 'Sun Im, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Catholic University of Korea'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sun Im, Assistant Professor, The Catholic University of Korea', 'investigatorFullName': 'Sun Im', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}