A Prospective, Randomized, Controlled Trial for the Efficacy of Repetitive Transcranial Magnetic Stimulation in Spinocerebellar Ataxia Type 3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- ICARS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 .Patients with detectable clinical signs and confirmed genetic diagnosis with SCA
- •SCA3 patients aged 20 - 80 years
- •Patients or their family members have informed consent to the study and signed relevant documents
排除标准
- •Patients who have concomitant epilepsy.
- •History of seizure or heat convulsion.
- •Patients on neuroleptics.
- •History or current unstable hypertension.
- •History of head injury or neurosurgical interventions.
- •History of any metal in the head (outside the mouth).
- •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.
- •History of migraine.
- •History of hearing loss.
- •History of cochlear implants
- •History of drug abuse or alcoholism.
- •Pregnancy or not using a reliable method of birth control.
- •Participation in current clinical study.
结局指标
主要结局
ICARS
时间窗: At baseline, during intervention period at 7 days and 15 days immediate after treatment.
The International Cooperative Ataxia Rating Scale (ICARS)
次要结局
- 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)
研究者
Ning Wang, MD., PhD.
National Natural Science Foundation of China（U1505222）
First Affiliated Hospital of Fujian Medical University