Repetitive Transcranial Magnetic Stimulation in SCA3 Patients

NCT ID: NCT05502432

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-17
• Study Completion Date: 2019-10-30

Brief Summary

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.

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.

Conditions

Spinocerebellar Ataxia Type 3

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active Repetitive Transcranial Magnetic Stimulation(rTMS)

15 days with 1 Hz of repetitive transcranial magnetic stimulation (rTMS) with active mood.

Group Type: ACTIVE_COMPARATOR

Active repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

Consecutive 15-day active treatment with 1 Hz of repetitive transcranial magnetic stimulation

Sham Repetitive Transcranial Magnetic Stimulation(rTMS)

15 days with 1 Hz of repetitive transcranial magnetic stimulation (rTMS) with sham mood.

Group Type: SHAM_COMPARATOR

Sham repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

Consecutive 15-day sham treatment with 1 Hz of repetitive transcranial magnetic stimulation

Interventions

Active repetitive transcranial magnetic stimulation

Consecutive 15-day active treatment with 1 Hz of repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

Sham repetitive transcranial magnetic stimulation

Consecutive 15-day sham treatment with 1 Hz of repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ning Wang, MD., PhD.

OTHER

Sponsor Role: lead

Responsible Party

Ning Wang, MD., PhD.

National Natural Science Foundation of China（U1505222）

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Neurology ,First Affiliated Hospital Fujian Medical University

Fuzhou, Fujian, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 11784843 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30809184 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10674722 (View on PubMed)

Other Identifiers

chiCTR180002013

Identifier Type: -

Identifier Source: org_study_id