Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2026-01-05 @ 6:15 PM
Study NCT ID:
NCT01853150
Status:
COMPLETED
Last Update Posted:
2018-07-24
First Post:
2013-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repetitive Transcranial Magnetic Stimulation for Freezing of Gait
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-23', 'studyFirstSubmitDate': '2013-05-10', 'studyFirstSubmitQcDate': '2013-05-10', 'lastUpdatePostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of steps', 'timeFrame': '2 days', 'description': 'The number of steps during the stand-walk-sit (SWS) test'}], 'secondaryOutcomes': [{'measure': 'The completion time during the SWS test', 'timeFrame': '2 days'}, {'measure': 'Freezing episodes of gait trajectory', 'timeFrame': '2 days'}, {'measure': 'Patient and Clinical Global Impression Scale', 'timeFrame': '2 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Parkinsonian Disorders']}, 'descriptionModule': {'briefSummary': 'Freezing of gait (FOG) means that patients cannot walk without any known causes, other than parkinsonism, which is very disabling symptom. Patients descirbe their feeling of the feet suddenly being glued to the floor. Transcranial magnetic stiumation is a noninvasive procedure using electromagnetic induction to stimulate brain. Transcranial magnetic stiumation (rTMS) can selectively change brain activity to enhance desired effects. The aim of this study is to the therapeutic effect of rTMS for the FOG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parkinson's disease or Primary progressive freezing of gait\n* age 18 and older\n* Freezing of gait\n\nExclusion Criteria:\n\n* pregnant or any, other medical, surgical, neurological or psychiatric conditions\n* other restrictions which prevent you from undergoing TMS recording, such as; surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), and/ or heart/cardiac lines\n* any past or current history of seizure disorder or epilepsy\n* unable to give informed consent"}, 'identificationModule': {'nctId': 'NCT01853150', 'briefTitle': 'Repetitive Transcranial Magnetic Stimulation for Freezing of Gait', 'organization': {'class': 'OTHER', 'fullName': 'Dongtan Sacred Heart Hospital'}, 'officialTitle': 'Repetitive Transcranial Magnetic Stimulation for Freezing of Gait', 'orgStudyIdInfo': {'id': '2013-022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rTMS Motor cortex', 'description': 'rTMS will be applied over the motor cortex', 'interventionNames': ['Device: rTMS Motor cortex']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'rTMS Supplementary motor area', 'description': 'rTMS will be applied over the supplementary motor area', 'interventionNames': ['Device: rTMS Supplementary motor area']}], 'interventions': [{'name': 'rTMS Motor cortex', 'type': 'DEVICE', 'armGroupLabels': ['rTMS Motor cortex']}, {'name': 'rTMS Supplementary motor area', 'type': 'DEVICE', 'armGroupLabels': ['rTMS Supplementary motor area']}]}, 'contactsLocationsModule': {'locations': [{'zip': '445-170', 'city': 'Hwaseong-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Dongtan Sacred Heart Hospital', 'geoPoint': {'lat': 37.20682, 'lon': 126.8169}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dongtan Sacred Heart Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Suk Yun Kang', 'investigatorAffiliation': 'Dongtan Sacred Heart Hospital'}}}}