Pre et Post-operative Evaluation of Patients With Tourette Syndrome Treated With High Frequency Bilateral Stimulation of the Anterior Part of the Internal Pallid Globus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Measure the severity of tics
研究概览
简要总结
Within an ongoing deep brain stimulation (DBS) program for Tourette syndrome (TS) at the Department of Neurology, Pitié-Salpêtrière Hospital, Paris/France, the investigator team plans to evaluate patients pre-operatively and then at one year intervals post-operatively until the 5-year mark has been achieved. The investigator team will investigate tic severity, psychiatric co-morbidities, quality of life, and neuropsychological measures.
详细描述
Since the completion of the STIC trial in 2017, the french team continues to offer DBS of the globus pallidus internus (GPi) to selected, treatment-refractory patients with TS. On average, three to four patients undergo surgery every year. Even though a first follow-up of the STIC cohort up to four years post-op indicates ongoing improvement of tic severity, many questions remains regarding the efficacy of GPi DBS in TS. These questions include frequent comorbidities of TS, quality of life, evolution of medication and stimulation parameters, as well as neuropsychological functioning. Therefore, the investigator proposes to evaluate all patients undergoing GPi DBS for TS to be evaluated comprehensively pre-operatively and once yearly after surgery until reaching the 5-year mark. The investigator team hopes these data may help to plan for future international multicenter trials, and provide indications on prognostic factors concerning response to GPi DBS in TS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tourette syndrome severe and drug-resistant eligible for bilateral deep brain stimulation
- •Person who voluntarily and knowledgeably agreed to participate in the study
排除标准
- •Non affiliation to a French social security system (recipient or assign) excluding AME
研究组 & 干预措施
Evaluation of patients with Tourette's Gilles Syndrome
Neurological and neuropsychological evaluations of patients with Tourette's Gilles syndrome treated with high frequency bilateral stimulation of the anterior part of the internal pallid globus
干预措施: Neurological and neuropsychological Follow-up after deep brain stimulation (Other)
Evaluation of patients with Tourette's Gilles Syndrome
Neurological and neuropsychological evaluations of patients with Tourette's Gilles syndrome treated with high frequency bilateral stimulation of the anterior part of the internal pallid globus
干预措施: EEG recordings (Device)
结局指标
主要结局
Measure the severity of tics
时间窗: Month 60
Measure the severity of tics, determined by the YGTSS-R (Yale Global Tic Severity Scale score - revised) . The overall score is between 0 (no TICS) and 100 (severity in TICS) therefore a score decrease is expected .
次要结局
未报告次要终点
