Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT01855633
Status:
RECRUITING
Last Update Posted:
2025-02-04
First Post:
2013-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2040-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2013-05-10', 'studyFirstSubmitQcDate': '2013-05-14', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2039-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Keyboard tapping test', 'timeFrame': '1 day', 'description': 'Participants will be asked to tap a key of a computer keyboard as fast as possible in five seconds. They will be asked to do three times. We will measure the number of tapping. The primary outcome will be the averaged data of the numbers.This will be done before and after 5-day rTMS intervention.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Stroke is one of the major causes of death in the World. Many stroke survivors may suffer from long-term sequelae of stroke such as hemiplegia. The effects of rehabilitation therapy are limited. The development of new treatment strategies is essential. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive method to stimulate the focal area of the brain for restoring brain function. The aim of this study is to investigate the therapeutic effect of rTMS on the motor recovery in patients with hemiplegic stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stroke patients with motor weakness\n* Medical research council (MRC) grade 0-4\n* More than 2 weeks after stroke onset\n* Age 18 years and older\n* Able to provide consent for the protocol\n\nExclusion Criteria:\n\n* History of previous symptomatic stroke\n* pregnant women\n* Persons with 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), intracardiac lines that may pose a physical hazard during magnetic stimulation will also be excluded\n* Patients with history of seizure disorder or epilepsy\n* Subjects without the capacity to give informed consent'}, 'identificationModule': {'nctId': 'NCT01855633', 'briefTitle': 'Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Dongtan Sacred Heart Hospital'}, 'officialTitle': 'Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke', 'orgStudyIdInfo': {'id': '2013-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tradtional Theta burst stimulation (TBS) rTMS', 'description': 'Participants will receive continuous theta burst stimulation (cTBS) rTMS to contralesional hemisphere based on a previous study (Huang et al., 2005)', 'interventionNames': ['Device: Traditional Theta burst stimulation (TBS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Modified TBS rTMS', 'description': 'Participants will receive modified cTBS rTMS to contralesional hemisphere based on a previous study (Nyffeler et al., 2006)', 'interventionNames': ['Device: Modified TBS rTMS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham rTMS', 'description': 'Participants will receive sham cTBS rTMS to contralesional hemisphere.', 'interventionNames': ['Device: Sham rTMS']}], 'interventions': [{'name': 'Traditional Theta burst stimulation (TBS)', 'type': 'DEVICE', 'armGroupLabels': ['Tradtional Theta burst stimulation (TBS) rTMS']}, {'name': 'Modified TBS rTMS', 'type': 'DEVICE', 'armGroupLabels': ['Modified TBS rTMS']}, {'name': 'Sham rTMS', 'type': 'DEVICE', 'armGroupLabels': ['Sham rTMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '445-170', 'city': 'Hwaseong-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Suk Yun Kang, MD, PhD', 'role': 'CONTACT', 'email': 'sukyunkang@hanmail.net', 'phone': '82-31-8086-2310'}, {'name': 'Ah-Young Jun, MD, MS', 'role': 'CONTACT', 'email': 'ayjun@hallym.or.kr', 'phone': '82-31-8086-2310'}, {'name': 'Suk Yun Kang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dongtan Sacred Heart Hospital', 'geoPoint': {'lat': 37.20682, 'lon': 126.8169}}], 'centralContacts': [{'name': 'Suk Yun Kang, MD, PhD', 'role': 'CONTACT', 'email': 'sukyunkang@hanmail.net', 'phone': '82-31-8086-2310'}, {'name': 'Ah-Young Jun, MD, MS', 'role': 'CONTACT', 'email': 'ayjun@hallym.or.kr', 'phone': '82-31-8086-2310'}]}, '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'}}}}