Repetitive Transcranial Magnetic Stimulation in SCA3 Patients

August 14, 2022 updated by: Ning Wang, MD., PhD.

A Prospective, Randomized, Controlled Trial for the Efficacy of Repetitive Transcranial Magnetic Stimulation in Spinocerebellar Ataxia Type 3

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Department of Neurology ,First Affiliated Hospital Fujian Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Active Comparator: Active Repetitive Transcranial Magnetic Stimulation(rTMS)
15 days with 1 Hz of repetitive transcranial magnetic stimulation (rTMS) with active mood.
Device: Active repetitive transcranial magnetic stimulation
Consecutive 15-day active treatment with 1 Hz of repetitive transcranial magnetic stimulation
Sham Comparator: Sham Repetitive Transcranial Magnetic Stimulation(rTMS)
15 days with 1 Hz of repetitive transcranial magnetic stimulation (rTMS) with sham mood.
Device: Sham repetitive transcranial magnetic stimulation
Consecutive 15-day sham treatment with 1 Hz of repetitive transcranial magnetic stimulation

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.
The International Cooperative Ataxia Rating Scale (ICARS)
At baseline, during intervention period at 7 days and 15 days immediate after treatment.

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
Berg Balance Scale (BBS)
At baseline, during intervention period at 7 days and 15 days immediate after treatment
SARA
Time Frame: At baseline, during intervention period at 7 days and 15 days immediate after treatment
Scale for the Assessment and Rating of Ataxia (SARA)
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
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.
At baseline, during intervention period at 7 days and 15 days immediate after treatment
10 Metre Walk Test
Time Frame: At baseline, during intervention period at 7 days and 15 days immediate after treatment
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.
At baseline, during intervention period at 7 days and 15 days immediate after treatment
Static Stability Test
Time Frame: At baseline and 15 days immediate after treatment
Static Stability Test is a objective test use Pro-kin machine to evaluate patient's standing balance.
At baseline and 15 days immediate after treatment
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: At baseline and 15 days immediate after treatment
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
At baseline and 15 days immediate after treatment
Athens Insomnia Scale (AIS)
Time Frame: At baseline and 15 days immediate after treatment
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).
At baseline and 15 days immediate after treatment
Mini-Mental State Examination (MMSE)
Time Frame: At baseline and 15 days immediate after treatment
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.
At baseline and 15 days immediate after treatment
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.
At baseline and 15 days immediate after treatmen
Hamilton Anxiety Scale (HAMA)
Time Frame: At baseline and 15 days immediate after treatmen
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).
At baseline and 15 days immediate after treatmen
Hamilton Depression Scale (HAMD)
Time Frame: At baseline and 15 days immediate after treatmen
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).
At baseline and 15 days immediate after treatmen

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ning Wang, MD., PhD.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2018

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 30, 2019

Study Registration Dates

First Submitted

September 19, 2019

First Submitted That Met QC Criteria

August 14, 2022

First Posted (Actual)

August 16, 2022

Study Record Updates

Last Update Posted (Actual)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 14, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • chiCTR180002013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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 [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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