NCT02052271已完成不适用
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 人开始时间: 2014年6月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change from baseline in tremor amplitude on clinical rating scale
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •Patients who are not enrolled at social security
研究组 & 干预措施
Essential tremor
Experimental
cerebellar stimulation
干预措施: Cathodal cerebellar transcranial direct current active stimulation (Device)
Placebo arm
Placebo Comparator
placebo stimulation
干预措施: Cathodal cerebellar transcranial direct current placebo stimulation (Device)
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)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Experimental Therapeutics in Essential Tremor Using Transcranial Direct Current StimulationEssential TremorNCT01579435Institut National de la Santé Et de la Recherche Médicale, France12
已完成
不适用
Investigating Transcranial Direct Current Stimulation (tDCS) in Accelerating Learning in a Healthy Older PopulationAssociative Memory in Healthy SubjectsNCT03467698The University of Texas at Dallas30
Unknown
不适用
tDCS for Dysphagia Associated to Brainstem StrokeDysphagiaNCT04308733Presidio Ospedaliero Garibaldi-Centro60
Unknown
不适用
Effects of Transcranial Direct Current Stimulation (tDCS) for the Treatment of Refractory EpilepsyEpilepsy IntractableNCT04325360University of Campinas, Brazil30
Unknown
不适用
Transcranial Direct Current Stimulation (tDCS) Enhancement of Trauma-focused Therapy for Posttraumatic Stress DisorderPost-traumatic Stress Disorder (PTSD)NCT01940549Tel-Aviv Sourasky Medical Center50