跳至主要内容
临床试验/NCT03604510
NCT03604510已完成不适用

Role of Frontal Cortex in the Pathophysiology of Gilles de la Tourette Syndrome (GTS)

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2018年2月2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
14
试验地点
2
主要终点
Electroencephalogram (EEG) signal

研究概览

简要总结

Tourette's syndrome (TS) is a debilitating and severe syndrome whose pathophysiology remains unclear.

In order to precise the cortical regions involved in the generation of tics, investigators will realize an electroencephalogram (EEG) recording in the frontal cortex of TS patients in ecological conditions (EEG-holter). Activity changes will be correlated with event markers of tics and neurovegetative parameters. Statistical analyses will be compared between epochs of EEG recording with tics and without tics. The aim is to define the cortical regions involved in the genesis of tics in order to consider new targets for cortical stimulation.

详细描述

Gilles de la Tourette syndrome (GTS) is a childhood-onset disorder characterized by the presence of multiple motor tics and at least one vocal tic often associated with psychiatric co-morbidity. The expression of tics range from brief, recurrent and non-rhythmic motor or vocal actions (simple tics) to complex motor or vocal sequences (complex tics). The pathophysiology of tics is not yet fully understood. Recent imaging data suggest that the pattern of functional connectivity in cortico-basal ganglia networks is disrupted in GTS patients and could reflect a defect in brain maturation. However, regions involved in the immediate genesis of tics remains unknown since it is difficult to capture on line the cortical changes associated with tic generation using imaging techniques due to moving artefacts. Moreover, tics are much more frequent in everyday life conditions than in the artificial conditions of a laboratory. The aim is to study cortical activity changes occurring before tic occurrence by using long duration recording of encephalographic activity (EEG) in ecological conditions through Holter EEG techniques (24h recordings). Recordings will be performed in 15 patients with a severe form of Tourette's syndromes. EEG changes will be correlated to event markers, voluntary monitored by patients or automatically recorded (accelerometers for motor tics). EEG epoch centered on tics will be compared to similar epochs without tics. The occurrence of tics will also be correlated with neurovegetative markers of emotions such as RR interval ECG variability and skin resistivity changes. The ultimate goal of this project is to define a potential therapeutic target of tics for chronic cortical stimulation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
12 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Tourette's syndrome since at least 2 years
  • Lack of psychiatric comorbidity of axis 1 (depression)
  • Y-YSGT score > 20
  • Social insurance in accordance with the french law

排除标准

  • Epilepsia
  • Patient with an implanted medical device
  • Severe mental or somatic disease
  • Risk of suicide,
  • Pregnant or breast feeding women
  • Patient under "curatelle" or "tutelle"
  • Patient hospitalized
  • no social insurance

研究组 & 干预措施

Electroencephalographic recordings

Experimental

Electroencephalographic recordings

干预措施: Electroencephalographic recordings (Procedure)

结局指标

主要结局

Electroencephalogram (EEG) signal

时间窗: During 24 hours

24 hours recording of encephalographic activity (EEG) in ecological conditions through Holter EEG.

次要结局

  • Obsessive-Compulsive Inventory-Revised Score (OCI-R)(Day 0)
  • Tic occurence(During 24 hours)
  • Disease duration(Day 0)
  • Neurovegetative marker of emotions : RR Interval(During 24 hours)
  • MINI (Mini International Neuropsychiatric Interview)(Day 0)
  • State Trait Anxiety Inventory (STAI A and B)(Day 0)
  • Age(Day 0)
  • Montgomery and Asberg Depression Rating Sacle (MADRS) Score(Day 0)
  • Gender(Day 0)
  • Neurovegetative marker of emotions : skin conductance(During 24 hours)
  • Yale Global Tic severity score (YGTS)(Day 0)
  • ADHD RS rating score (ADHD RS rating Scale)(Day 0)
  • Global Assessment of Functioning Score (Global Assessment of Functioning Scale)(Day 0)
  • Yale Brown Obsessive Compulsive Score (Y-BOCS Scale)(Day 0)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Role of Frontal Cortex in the Pathophysiology of... | 临床试验