Repetitive Transcranial Magnetic Stimulation in SCA3 Patients

Ning Wang, MD., PhD.39 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Spinocerebellar Ataxia Type 3

Interventions

Active repetitive transcranial magnetic stimulationDEVICE

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

Sham repetitive transcranial magnetic stimulationDEVICE

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Neurology ,First Affiliated Hospital Fujian Medical University

Fuzhou, Fujian, China

Outcomes

Primary Outcomes

ICARS

The International Cooperative Ataxia Rating Scale (ICARS)

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

Secondary Outcomes

BBS

Berg Balance Scale (BBS)

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

SARA

Scale for the Assessment and Rating of Ataxia (SARA)

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

Data from ClinicalTrials.gov

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