NCT02039206已完成2 期
The Influence of Deep Repetitive Transcranial Magnetic Stimulation (TMS) on Cerebellar Signs in Patients With Spinocerebellar Ataxia Type 3 (SCA3 - Machado Joseph Disease)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Brainsway
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Scale for the Assessment and Rating of Ataxia (SARA)
研究概览
简要总结
To test the effects of low frequency deep rTMS using the novel HCERMJD-coil on cerebellar deficits in patients with SCA3 and to establish its safety in this population.
Investigator is anticipate that stimulation of the cerebellum with the novel HCERMJD-coil may induce significantly therapeutic effects in patients with SCA3 and will pave the way for establishing a novel and effective treatment for this disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •SCA3 patients aged 20 - 80 years, with detectable clinical signs and confirmed genetic diagnosis.
排除标准
- •Patients who have concomitant epilepsy.
- •History of seizure or heat convulsion.
- •Patients on neuroleptics.
- •Patients with dementia (MMSE<25) or any unstable medical disorder.
- •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 or clinical study within 30 days prior to this study.
研究组 & 干预措施
Treatment
Experimental
Deep TMS
干预措施: Deep TMS (Device)
结局指标
主要结局
Scale for the Assessment and Rating of Ataxia (SARA)
时间窗: 30 days
次要结局
未报告次要终点
研究者
研究点 (1)
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