Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT05535504
Status:
RECRUITING
Last Update Posted:
2025-06-24
First Post:
2022-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy & Safety of rTMS for Upper-limb Motor Function Recovery in Subcortical and Brainstem Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006429', 'term': 'Hemiplegia'}, {'id': 'D002544', 'term': 'Cerebral Infarction'}], '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'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2022-09-07', 'studyFirstSubmitQcDate': '2022-09-07', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Vital sign', 'timeFrame': 'upto 42 days', 'description': 'Before rTMS (baseline), immediately after the completion of 10 sessions of rTMS, and 4 weeks after the completion of 10 sessions of rTMS'}], 'primaryOutcomes': [{'measure': 'Box and Block test', 'timeFrame': 'upto 42 days', 'description': 'Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS'}], 'secondaryOutcomes': [{'measure': 'Box and Block test', 'timeFrame': 'upto 14 days', 'description': 'Before rTMS (baseline) and immediately after the completion of 10 sessions of rTMS'}, {'measure': 'Fugl-Meyer Assessment Scale', 'timeFrame': 'upto 42 days', 'description': 'Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS'}, {'measure': 'modified Barthel Index (the Korean version)', 'timeFrame': 'upto 42 days', 'description': 'Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS'}, {'measure': 'National Institutes of Health Stroke Scale', 'timeFrame': 'upto 42 days', 'description': 'Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS'}, {'measure': 'Finger tapping', 'timeFrame': 'upto 42 days', 'description': 'Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS'}, {'measure': 'Brunnstrom stage (hand and arm)', 'timeFrame': 'upto 42 days', 'description': 'Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS'}, {'measure': 'Modified Ashworth scale (wrist flexor, wrist extensor, elbow flexor, elbow extensor, and finger flexor)', 'timeFrame': 'upto 42 days', 'description': 'Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS'}, {'measure': 'Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck)', 'timeFrame': 'upto 42 days', 'description': 'Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Transcranial magnetic stimulation', 'Rehabilitation', 'Neuronal plasticity', 'Subcortical infarction'], 'conditions': ['Stroke', 'Hemiplegia', 'Subcortical Infarction']}, 'referencesModule': {'references': [{'pmid': '37693768', 'type': 'DERIVED', 'citation': 'Cho HM, Cha S, Sohn MK, Jee S, Chang WK, Kim WS, Paik NJ. Investigation of the efficacy of low-frequency repetitive transcranial magnetic stimulation on upper-limb motor recovery in subacute ischemic stroke without cortical involvement: a protocol paper for a multi-center, double-blind randomized controlled trial. Front Neurol. 2023 Aug 25;14:1216510. doi: 10.3389/fneur.2023.1216510. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the efficacy and safety of repetitive transcranial magnetic stimulation applied with an electromagnetic therapy stimulator 'ALTMS-A' for upper-limb motor function recovery with the sham control group for those who need upper-limb rehabilitation treatment for subcortical and brainstem stroke", 'detailedDescription': 'After low-frequency repetitive transcranial magnetic stimulation (rTMS) over the contralesional motor cortex (M1), the score of the Box and Block test increased immediately, especially in patients without cortical involvement.\n\nEighty-eight patients will be recruited and divided into two groups. Each group will receive 10 sessions of the real rTMS or sham rTMS over the contralesional primary motor cortex. Each rTMS session consists of low-frequency (1Hz) 1800 stimulations.\n\nThe objective of this study is to evaluate the efficacy and safety of rTMS for upper-limb motor function in patients with subcortical and brainstem stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19-80 years old\n* Radiologically confirmed ischemic stroke with subcortical and brainstem lesions within 90 days\n* Fugl-Meyer assessment scale (upper extremity) \\> 15\n* Mini-mental status exam (the Korean version) \\> 14 with appropriate cognitive function\n* Written informed consent\n\nExclusion Criteria:\n\n* Fugl-Meyer assessment scale (wrist) \\< 1 or Fugl-Meyer assessment scale (hand) \\< 1\n* Hemorrhagic stroke or traumatic brain injury\n* Cerebellar stroke\n* Previous history of stroke\n* Traumatic brain injury\n* Previous history of brain surgery\n* Need for intensive care due to complications associated with stroke (e.g. pneumonia, infection, hemodynamic instability)\n* History of psychological or neurological diseases\n* History of pain or muscular weakness of upper limbs which may interfere with rehabilitation\n* History of seizure or epilepsy\n* Aphasia\n* Skin lesions in the stimulation site of scalp\n* Intracranial metal implant\n* Inability to receive regular physical or occupational therapy\n* Disagreement to use contraception in women of childbearing age'}, 'identificationModule': {'nctId': 'NCT05535504', 'briefTitle': 'The Efficacy & Safety of rTMS for Upper-limb Motor Function Recovery in Subcortical and Brainstem Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': "Multi-center, Prospective, Comparative, Randomized, Double Blind, Superior, Pivotal Study to Compare and Evaluate the Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation Applied With an Electromagnetic Therapy Stimulator 'ALTMS-A' for Upper-limb Motor Function Recovery With the Sham Control Group for Those Who Need Upper-limb Rehabilitation Treatment for Subcortical and Brainstem Stroke (Ischemic)", 'orgStudyIdInfo': {'id': 'E-2205-756-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'real rTMS', 'description': 'Use the real rTMS coil', 'interventionNames': ['Device: Low-frequency rTMS (experimental)']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham rTMS', 'description': 'Use the sham rTMS coil', 'interventionNames': ['Device: Low-frequency rTMS (sham comparator)']}], 'interventions': [{'name': 'Low-frequency rTMS (experimental)', 'type': 'DEVICE', 'description': 'Frequency: Low-frequency (1Hz) rTMS / Intensity: 100% of resting motor threshold / Location: motor hotspot of the contralesional primary motor cortex (the first dorsal interosseous muscle) / Number of total stimuli : 1800 ; Coil orientation: tangential to scalp', 'armGroupLabels': ['real rTMS']}, {'name': 'Low-frequency rTMS (sham comparator)', 'type': 'DEVICE', 'description': 'Frequency: Low-frequency (1Hz) rTMS / Intensity: 100% of resting motor threshold / motor hotspot of the contralesional primary motor cortex (the first dorsal interosseous muscle) / Number of total stimuli : 1800 ; Coil orientation: vertical to scalp', 'armGroupLabels': ['sham rTMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Korea, Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Nam-Jong Paik, MD, PhD', 'role': 'CONTACT', 'email': 'njpaik@snu.ac.kr', 'phone': '82-031-787-7731'}, {'name': 'Won Kee Chang, MD', 'role': 'CONTACT', 'email': 'wonkee.chang@gmail.com', 'phone': '82-031-787-7739'}, {'name': 'Nam-jong Paik, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '35015', 'city': 'Daejeon', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Min Kyun Sohn, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Department of Rehabilitation Medicine, Chungnam National University Hospital, Korea', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}], 'centralContacts': [{'name': 'Won Kee Chang, MD', 'role': 'CONTACT', 'email': 'wonkee.chang@gmail.com', 'phone': '82-031-787-7739'}, {'name': 'Yeo Kyung Yoon', 'role': 'CONTACT', 'email': 'yyk97504@naver.com', 'phone': '82-031-787-7739'}], 'overallOfficials': [{'name': 'Nam-Jong Paik, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chungnam National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nam-Jong Paik', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}