Thérapeutique expérimentale du Tremblement Essentiel Par la Stimulation Transcranienne Par Courant Direct (tDCS) du Cortex Cerebelleux

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 16 人2014年6月3日

干预措施Cathodal cerebellar transcranial direct current active stimulation Cathodal cerebellar transcranial direct current placebo stimulation

概览

阶段: 不适用
干预措施: Cathodal cerebellar transcranial direct current active stimulation
疾病 / 适应症: Essential Tremor
发起方: Institut National de la Santé Et de la Recherche Médicale, France
入组人数: 16
试验地点: 2
主要终点: Change from baseline in tremor amplitude on clinical rating scale
状态: 已完成
最后更新: 8天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The purpose of this study is to determine whether transcranial cathodal direct current stimulation (tDCS) delivered over the cerebellum can improve essential tremor.

注册库

clinicaltrials.gov

开始日期

2014年6月3日

结束日期

2018年3月27日

最后更新

8天前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Institut National de la Santé Et de la Recherche Médicale, France

责任方

Sponsor

入排标准

入选标准

•Age ≥ 18 years and ≤ 65 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
•mini-mental status score \>24

排除标准

•Age \< 18 years and \> 65 years
•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, loss of conciousness or current active epilepsy
•Contraindication for MRI or TMS study
•Intake of antiepileptic medications for essential tremor (barbiturates, gabapentine, topiramate, clonazepam), within the 7 days preceeding the first visit
•alcohol intake within the 24 hours preceeding the first visit
•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

研究组 & 干预措施

Essential tremor

cerebellar stimulation

干预措施: Cathodal cerebellar transcranial direct current active stimulation

Placebo arm

placebo stimulation

干预措施: Cathodal cerebellar transcranial direct current placebo stimulation

结局指标

主要结局

Change from baseline in tremor amplitude on clinical rating scale

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, 10 mn, 60 mn and 90 mn after the end of tDCS)
Change from baseline of amplitude of motor evoked potentials elicited by TMS(10 mn, 60 mn and 90 mn after tDCS)
Change from baseline in tremor amplitude on clinical rating scale(During tDCS, 60 mn and 90 mn after the end of tDCS)
Change from baseline in tremor amplitude on accelerometric recording(During tDCS, 10 mn, 60 mn and 90 mn after the end of tDCS)
Change from baseline in tremor amplitude on digitized tablet(During tDCS, 10 mn, 60 mn and 90 mn after the end of tDCS)