Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-03 @ 5:31 PM
Study NCT ID:
NCT05502432
Status:
COMPLETED
Last Update Posted:
2022-08-16
First Post:
2019-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repetitive Transcranial Magnetic Stimulation in SCA3 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017827', 'term': 'Machado-Joseph Disease'}], 'ancestors': [{'id': 'D020754', 'term': 'Spinocerebellar Ataxias'}, {'id': 'D002524', 'term': 'Cerebellar Ataxia'}, {'id': 'D002526', 'term': 'Cerebellar Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013132', 'term': 'Spinocerebellar Degenerations'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D001259', 'term': 'Ataxia'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-14', 'studyFirstSubmitDate': '2019-09-19', 'studyFirstSubmitQcDate': '2022-08-14', 'lastUpdatePostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Tandem gait', 'timeFrame': 'At baseline, during intervention period at 7 days and 15 days immediate after treatment', 'description': 'Tandem gait is a gait (method of walking or running) where the toes of the back foot touch the heel of the front foot at each step.'}, {'measure': '10 Metre Walk Test', 'timeFrame': 'At baseline, during intervention period at 7 days and 15 days immediate after treatment', 'description': 'The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.'}, {'measure': 'Static Stability Test', 'timeFrame': 'At baseline and 15 days immediate after treatment', 'description': "Static Stability Test is a objective test use Pro-kin machine to evaluate patient's standing balance."}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'At baseline and 15 days immediate after treatment', 'description': 'The Pittsburgh Sleep Quality Index (PSQI) is the most commonly used instrument to assess the subjective sleep quality of adults in clinical and community settings'}, {'measure': 'Athens Insomnia Scale (AIS)', 'timeFrame': 'At baseline and 15 days immediate after treatment', 'description': 'The AIS is a self-reported questionnaire designed to measure the severity of insomnia based on the diagnostic criteria of the International Classification of Diseases, 10th revision (ICD-10).'}, {'measure': 'Mini-Mental State Examination (MMSE)', 'timeFrame': 'At baseline and 15 days immediate after treatment', 'description': 'In addressing cognitive screening tools, the MMSE and the MoCA are the most commonly used methods in cognitive impairment detection in both clinical and research fields.'}, {'measure': 'Montreal Cognitive Assessment (MoCA）', 'timeFrame': 'At baseline and 15 days immediate after treatmen', 'description': 'In addressing cognitive screening tools, the MMSE and the MoCA are the most commonly used methods in cognitive impairment detection in both clinical and research fields.'}, {'measure': 'Hamilton Anxiety Scale (HAMA)', 'timeFrame': 'At baseline and 15 days immediate after treatmen', 'description': 'HAMA contains 14 questions; each question includes 5 items. Responses are scored as 0 (never), 1 (mild), 2 (moderate), 3 (severe), or 4 (extremely serious). The total score of HAMA is operationally categorized as follows: no anxiety (score 0-6), mild and moderate anxiety (score 7-13), severe anxiety (score ≥ 14).'}, {'measure': 'Hamilton Depression Scale (HAMD)', 'timeFrame': 'At baseline and 15 days immediate after treatmen', 'description': 'HAMD contains 17 questions; each question includes 5 items. Responses are scored as 0 (never), 1 (mild), 2 (moderate), 3 (severe), or 4 (extremely serious). The total score of HAMD can be classified into normal (score 0-6), mild and moderate (score 7-23), severe depression (score ≥ 24).'}], 'primaryOutcomes': [{'measure': 'ICARS', 'timeFrame': 'At baseline, during intervention period at 7 days and 15 days immediate after treatment.', 'description': 'The International Cooperative Ataxia Rating Scale (ICARS)'}], 'secondaryOutcomes': [{'measure': 'BBS', 'timeFrame': 'At baseline, during intervention period at 7 days and 15 days immediate after treatment', 'description': 'Berg Balance Scale (BBS)'}, {'measure': 'SARA', 'timeFrame': 'At baseline, during intervention period at 7 days and 15 days immediate after treatment', 'description': 'Scale for the Assessment and Rating of Ataxia (SARA)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Device:Active repetitive transcranial magnetic stimulation', 'Device:Sham repetitive transcranial magnetic stimulation'], 'conditions': ['Spinocerebellar Ataxia Type 3']}, 'referencesModule': {'references': [{'pmid': '11784843', 'type': 'BACKGROUND', 'citation': 'Shiga Y, Tsuda T, Itoyama Y, Shimizu H, Miyazawa KI, Jin K, Yamazaki T. Transcranial magnetic stimulation alleviates truncal ataxia in spinocerebellar degeneration. J Neurol Neurosurg Psychiatry. 2002 Jan;72(1):124-6. doi: 10.1136/jnnp.72.1.124. No abstract available.'}, {'pmid': '30809184', 'type': 'BACKGROUND', 'citation': 'Manor B, Greenstein PE, Davila-Perez P, Wakefield S, Zhou J, Pascual-Leone A. Repetitive Transcranial Magnetic Stimulation in Spinocerebellar Ataxia: A Pilot Randomized Controlled Trial. Front Neurol. 2019 Feb 12;10:73. doi: 10.3389/fneur.2019.00073. eCollection 2019.'}, {'pmid': '10674722', 'type': 'BACKGROUND', 'citation': 'Shimizu H, Tsuda T, Shiga Y, Miyazawa K, Onodera Y, Matsuzaki M, Nakashima I, Furukawa K, Aoki M, Kato H, Yamazaki T, Itoyama Y. Therapeutic efficacy of transcranial magnetic stimulation for hereditary spinocerebellar degeneration. Tohoku J Exp Med. 1999 Nov;189(3):203-11. doi: 10.1620/tjem.189.203.'}]}, 'descriptionModule': {'briefSummary': 'Machado-Joseph Disease (MJD) or spinocerebellar ataxia type 3 (SCA3) is the most common spinocerebellar ataxia worldwide.Repetitive transcranial magnetic stimulation (rTMS) is a form of brain stimulation therapy used to treat depression and cerebellar ataxias. In this randomized, double-blind, sham-controlled study, the investigators will evaluate whether a 15 day treatment with 1 Hz of repetitive transcranial magnetic stimulation (rTMS) can improve symptoms (motor symptoms and non-motor symptoms) in patients with MJD.', 'detailedDescription': 'Machado-Joseph Disease (MJD) or spinocerebellar ataxia type 3 (SCA3) is the most common spinocerebellar ataxia worldwide. MJD shows remarked clinical heterogeneity and presents with various clinical manifestations, including cerebellar ataxia, limb incoordination, dysarthria, sleep disorders, axonal neuropathy, dystonia, pyramidal signs and, diplopia. No effective treatment is currently available for MJD.\n\nRepetitive transcranial magnetic stimulation (rTMS)enables non-invasive modulation of cortical excitability. rTMS targeting cerebellar structures is capable of inducing long-lasting changes in the excitability of cerebello-thalamocortical pathways.\n\nSubjects will be randomized in two groups, one receiving a consecutive 15-day treatment with 1 Hz of repetitive transcranial magnetic stimulation and the other receiving sham stimulation with identical parameters. Patients will be clinically assessed at baseline, during intervention period at 7 days and 15 days immediate after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1 .Patients with detectable clinical signs and confirmed genetic diagnosis with SCA3.\n\n2\\. SCA3 patients aged 20 - 80 years 3. Patients or their family members have informed consent to the study and signed relevant documents\n\nExclusion Criteria:\n\n* 1\\. Patients who have concomitant epilepsy. 2. History of seizure or heat convulsion. 3. Patients on neuroleptics. 4. History or current unstable hypertension. 5. History of head injury or neurosurgical interventions. 6. History of any metal in the head (outside the mouth). 7. Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.\n\n 8\\. History of frequent or severe headaches. 9. History of migraine. 10. History of hearing loss. 11. History of cochlear implants 12. History of drug abuse or alcoholism. 13. Pregnancy or not using a reliable method of birth control. 14. Participation in current clinical study.'}, 'identificationModule': {'nctId': 'NCT05502432', 'briefTitle': 'Repetitive Transcranial Magnetic Stimulation in SCA3 Patients', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Fujian Medical University'}, 'officialTitle': 'A Prospective, Randomized, Controlled Trial for the Efficacy of Repetitive Transcranial Magnetic Stimulation in Spinocerebellar Ataxia Type 3', 'orgStudyIdInfo': {'id': 'chiCTR180002013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Repetitive Transcranial Magnetic Stimulation(rTMS)', 'description': '15 days with 1 Hz of repetitive transcranial magnetic stimulation (rTMS) with active mood.', 'interventionNames': ['Device: Active repetitive transcranial magnetic stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Repetitive Transcranial Magnetic Stimulation(rTMS)', 'description': '15 days with 1 Hz of repetitive transcranial magnetic stimulation (rTMS) with sham mood.', 'interventionNames': ['Device: Sham repetitive transcranial magnetic stimulation']}], 'interventions': [{'name': 'Active repetitive transcranial magnetic stimulation', 'type': 'DEVICE', 'description': 'Consecutive 15-day active treatment with 1 Hz of repetitive transcranial magnetic stimulation', 'armGroupLabels': ['Active Repetitive Transcranial Magnetic Stimulation(rTMS)']}, {'name': 'Sham repetitive transcranial magnetic stimulation', 'type': 'DEVICE', 'description': 'Consecutive 15-day sham treatment with 1 Hz of repetitive transcranial magnetic stimulation', 'armGroupLabels': ['Sham Repetitive Transcranial Magnetic Stimulation(rTMS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350005', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Department of Neurology ,First Affiliated Hospital Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ning Wang, MD., PhD.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'National Natural Science Foundation of China（U1505222）', 'investigatorFullName': 'Ning Wang, MD., PhD.', 'investigatorAffiliation': 'First Affiliated Hospital of Fujian Medical University'}}}}