- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05502432
Repetitive Transcranial Magnetic Stimulation in SCA3 Patients
A Prospective, Randomized, Controlled Trial for the Efficacy of Repetitive Transcranial Magnetic Stimulation in Spinocerebellar Ataxia Type 3
Study Overview
Status
Conditions
Detailed Description
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.
Repetitive 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.
Subjects 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Fujian
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Fuzhou, Fujian, China, 350005
- Department of Neurology ,First Affiliated Hospital Fujian Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1 .Patients with detectable clinical signs and confirmed genetic diagnosis with SCA3.
2. SCA3 patients aged 20 - 80 years 3. Patients or their family members have informed consent to the study and signed relevant documents
Exclusion Criteria:
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.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Active Repetitive Transcranial Magnetic Stimulation(rTMS)
15 days with 1 Hz of repetitive transcranial magnetic stimulation (rTMS) with active mood.
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Consecutive 15-day active treatment with 1 Hz of repetitive transcranial magnetic stimulation
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Sham Comparator: Sham Repetitive Transcranial Magnetic Stimulation(rTMS)
15 days with 1 Hz of repetitive transcranial magnetic stimulation (rTMS) with sham mood.
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Consecutive 15-day sham treatment with 1 Hz of repetitive transcranial magnetic stimulation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ICARS
Time Frame: At baseline, during intervention period at 7 days and 15 days immediate after treatment.
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The International Cooperative Ataxia Rating Scale (ICARS)
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At baseline, during intervention period at 7 days and 15 days immediate after treatment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BBS
Time Frame: At baseline, during intervention period at 7 days and 15 days immediate after treatment
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Berg Balance Scale (BBS)
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At baseline, during intervention period at 7 days and 15 days immediate after treatment
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SARA
Time Frame: At baseline, during intervention period at 7 days and 15 days immediate after treatment
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Scale for the Assessment and Rating of Ataxia (SARA)
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At baseline, during intervention period at 7 days and 15 days immediate after treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tandem gait
Time Frame: At baseline, during intervention period at 7 days and 15 days immediate after treatment
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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.
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At baseline, during intervention period at 7 days and 15 days immediate after treatment
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10 Metre Walk Test
Time Frame: At baseline, during intervention period at 7 days and 15 days immediate after treatment
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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.
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At baseline, during intervention period at 7 days and 15 days immediate after treatment
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Static Stability Test
Time Frame: At baseline and 15 days immediate after treatment
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Static Stability Test is a objective test use Pro-kin machine to evaluate patient's standing balance.
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At baseline and 15 days immediate after treatment
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Pittsburgh Sleep Quality Index (PSQI)
Time Frame: At baseline and 15 days immediate after treatment
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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
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At baseline and 15 days immediate after treatment
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Athens Insomnia Scale (AIS)
Time Frame: At baseline and 15 days immediate after treatment
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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).
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At baseline and 15 days immediate after treatment
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Mini-Mental State Examination (MMSE)
Time Frame: At baseline and 15 days immediate after treatment
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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.
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At baseline and 15 days immediate after treatment
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Montreal Cognitive Assessment (MoCA)
Time Frame: At baseline and 15 days immediate after treatmen
|
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.
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At baseline and 15 days immediate after treatmen
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Hamilton Anxiety Scale (HAMA)
Time Frame: At baseline and 15 days immediate after treatmen
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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).
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At baseline and 15 days immediate after treatmen
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Hamilton Depression Scale (HAMD)
Time Frame: At baseline and 15 days immediate after treatmen
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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).
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At baseline and 15 days immediate after treatmen
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Genetic Diseases, Inborn
- Neurodegenerative Diseases
- Dyskinesias
- Spinal Cord Diseases
- Heredodegenerative Disorders, Nervous System
- Cerebellar Diseases
- Cerebellar Ataxia
- Ataxia
- Spinocerebellar Ataxias
- Spinocerebellar Degenerations
- Machado-Joseph Disease
Other Study ID Numbers
- chiCTR180002013
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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