Repetitive Transcranial Magnetic Stimulation in SCA3 Patients

NCT05502432 | Completed

• 1 other identifier: chiCTR180002013
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinocerebellar Ataxia Type 3

Keywords

Device:Active repetitive transcranial magnetic stimulation; Device:Sham repetitive transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• ICARS

  The International Cooperative Ataxia Rating Scale (ICARS)

  At baseline, during intervention period at 7 days and 15 days immediate after treatment.

Secondary Outcomes (2)

• BBS

  At baseline, during intervention period at 7 days and 15 days immediate after treatment

• SARA

  At baseline, during intervention period at 7 days and 15 days immediate after treatment

Other Outcomes (9)

• Tandem gait

  At baseline, during intervention period at 7 days and 15 days immediate after treatment

• 10 Metre Walk Test

  At baseline, during intervention period at 7 days and 15 days immediate after treatment

• Static Stability Test

  At baseline and 15 days immediate after treatment

Study Arms (2)

Active Repetitive Transcranial Magnetic Stimulation(rTMS)

ACTIVE COMPARATOR

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

Device: Active repetitive transcranial magnetic stimulation

Sham Repetitive Transcranial Magnetic Stimulation(rTMS)

SHAM COMPARATOR

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

Device: Sham repetitive transcranial magnetic stimulation

Interventions

Active repetitive transcranial magnetic stimulation DEVICE

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

Active Repetitive Transcranial Magnetic Stimulation(rTMS)

Sham repetitive transcranial magnetic stimulation DEVICE

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

Sham Repetitive Transcranial Magnetic Stimulation(rTMS)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with detectable clinical signs and confirmed genetic diagnosis with SCA3.
• \. SCA3 patients aged 20 - 80 years 3. Patients or their family members have informed consent to the study and signed relevant documents

You may not qualify if:

• \. 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.
• \. 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.

Sponsors & Collaborators

• Ning Wang, MD., PhD.: lead

Study Sites (1)

Department of Neurology ,First Affiliated Hospital Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

Related Publications (3)

• 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: 11784843 BACKGROUND

• 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: 30809184 BACKGROUND

• 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.

  PMID: 10674722 BACKGROUND

MeSH Terms

Conditions

Machado-Joseph Disease

Condition Hierarchy (Ancestors)

Spinocerebellar Ataxias; Cerebellar Ataxia; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinocerebellar Degenerations; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Ataxia; Dyskinesias; Neurologic Manifestations; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: National Natural Science Foundation of China（U1505222）

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: August 16, 2022
• Study Start: December 17, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 30, 2019
• Last Updated: August 16, 2022

Record last verified: 2022-08

Locations

CN (1)