Repetitive Transcranial Magnetic Stimulation in SCA3 Patients

Study Overview
=================
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.

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

Conditions
-----------------
Spinocerebellar Ataxia Type 3

Intervention / Treatment
-----------------
* Device: Active repetitive transcranial magnetic stimulation
* Device: Sham repetitive transcranial magnetic stimulation


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Repetitive Transcranial Magnetic Stimulation(rTMS)<br>15 days with 1 Hz of repetitive transcranial magnetic stimulation (rTMS) with active mood. | Device: Active repetitive transcranial magnetic stimulation<br>* Consecutive 15-day active treatment with 1 Hz of repetitive transcranial magnetic stimulation<br>|
| Sham Comparator: Sham Repetitive Transcranial Magnetic Stimulation(rTMS)<br>15 days with 1 Hz of repetitive transcranial magnetic stimulation (rTMS) with sham mood. | Device: Sham repetitive transcranial magnetic stimulation<br>* Consecutive 15-day sham treatment with 1 Hz of repetitive transcranial magnetic stimulation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICARS | 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 | Berg Balance Scale (BBS) | At baseline, during intervention period at 7 days and 15 days immediate after treatment | 
| SARA | Scale for the Assessment and Rating of Ataxia (SARA) | At baseline, during intervention period at 7 days and 15 days immediate after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Device:Active repetitive transcranial magnetic stimulation, Device:Sham repetitive transcranial magnetic stimulation