NCT01579435已完成不适用
Thérapeutique expérimentale du Tremblement Essentiel Par la Stimulation Trans-crânienne Par Courant Direct (tDCS) du Cortex cérébelleux et du Cortex Moteur. Etude Exploratoire.
Institut National de la Santé Et de la Recherche Médicale, France2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2012年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change from baseline in tremor amplitude on accelerometric recording 10 minutes after the end of tDCS
研究概览
简要总结
The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) delivered over the motor cortex or the cerebellum can improve essential tremor and to identify the cerebral mechanisms involved in these potential effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and < 50 years
- •Important essential tremor (bilateral postural and/or action tremor since more than one year)
- •Normal physical and neurological examination, except for essential tremor
- •Insufficient efficiency of usual essential tremor's treatment
- •No treatment altering the cortical excitability
- •Agreement to use a medically acceptable method of contraception throughout the study for female of childbearing potential
排除标准
- •Cervical tremor
- •Current neurological or psychiatric illness other than essential tremor
- •Individual who is on medication which is known to lower seizure threshold
- •Previous history of seizure(s), malaise or current active epilepsy
- •Contraindication for MRI or TMS study
- •Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control
- •Individual who have MMS ≤ 24/30 or patients legally protected or inability to provide an informed consent
- •Simultaneous participation in another clinical trial
- •Patients who are not enrolled at social security
结局指标
主要结局
Change from baseline in tremor amplitude on accelerometric recording 10 minutes after the end of tDCS
时间窗: 10 minutes after the end of tDCS
次要结局
- Change from baseline in tremor amplitude on electromyographic recordings(During tDCS (expected average of 15 minutes), 10 and 60 mn after the end of tDCS)
- Change from baseline in tremor amplitude on digitized tablet(During tDCS (expected average of 15 minutes), 10 and 60 mn after the end of tDCS)
- Change from baseline in tremor amplitude on accelerometric recording(During tDCS (expected average of 15 minutes) and 60 minutes after the end of tDCS)
研究者
研究点 (2)
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