Treatment of Gilles de la Tourette Syndrome by Bilateral Stimulation of the Internal Part of the Globus PALLIDUS
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To evaluate the therapeutic effect of the high frequency bilateral stimulation of GPI in severe forms and invalidating MGT, in a protocol randomized as a double blind man in parallel groups.
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of bilateral pallidal stimulation in patients with a severe form of Gilles de la Tourette syndrome.
详细描述
It acts of a randomized study, in parallel, double group blind, multi-centric relating to 14 patients.
The interest of this multicentric study, which will be carried out in centers specialized in the field of major cerebral stimulation with for each one a multidisciplinary team, is to carry out a homogeneous protocol which should make it possible to give a clear response in term of effectiveness for this treatment in this pathology.
The evaluation will be:
- neurological (YGTSS, video scale of the tics);
- psychiatric, with in particular of the specific psychopathological evaluations centered on mood;
- neuropsychological, centered on impulsiveness;
- functional calculus evaluating total operation and the social adaptation;
- neurophysiological (recording of the neuronal activities).
Calculations of the number of subjects necessary showed, by laying down the principal objective at an improvement of at least 60 % of the score of the YGTSS under treatment, which 14 subjects will make it possible to show a significant difference with the procedure placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe form of GTS
- •age 18 to 60 years
- •failure of medical treatment (including neuroleptics)
排除标准
- •Major depression
- •Psychotic symptoms
- •Severe personality disorder
结局指标
主要结局
To evaluate the therapeutic effect of the high frequency bilateral stimulation of GPI in severe forms and invalidating MGT, in a protocol randomized as a double blind man in parallel groups.
时间窗: during the 44 months
The assumption tested is that of the frank improvement (> 60% on scale YGTSS) of the symptoms of the MGT by the bilateral stimulation of GPI in its former part.
时间窗: at the end of 44 months
次要结局
- To establish correlations between the localization of the studs of stimulation (retiming atlas/IRM) and the symptoms(during the 44 months)
- To determine the modifications of cerebral activation induced by the bilateral stimulation of GPI at the time of the improvement of the neurological symptoms (study in Mtoe).(during the 44 months)
- To evaluate time necessary to obtaining the maximum effect and its evolution after this one (maintenance or not of the effect in the course of time)(during the study)
- To study the effects of the stimulation of GPI in its former part, on the driving tics simple and complex, vocal, the self-mutilations, and the psychopathology of which time, emotions and impulsiveness(during the 44 months)
- To evaluate the repercussion of this technique on the sociological-professional handicap, operation and the adaptation(during the 44 months)
- To seek determinants before intervention of the effectiveness of stimulation (determining neurological, psychiatric, neuropsychological, functional)(during the 44 months)