NCT02253498Unknown1 期
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Tourette Syndrome
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 主要终点
- Modified Rush Video Rating Scale (mRVRS)
研究概览
简要总结
The purpose of this clinical study is to verify the long term effectiveness and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with cognitive, behavioral, and functional disability of Tourette Syndrome.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is aged 18 or older
- •Patient Group with Tourette's syndrome, Diagnosis of Tourette Syndrome by DSM-IV
排除标准
- •Major Depressive Episode within the previous 6 months
- •Schizophrenia or other psychotic disorder.Participate in other clinical trial;
- •Has a life expectancy of < 1 year.
- •The investigator and/or enrollment review committee, would preclude participation in the study.
研究组 & 干预措施
Sham Stimulation
Sham Comparator
placebo
干预措施: deep brain stimulation (DBS) (Device)
Deep Brain Stimulation
Experimental
Deep Brain Stimulation is on
干预措施: deep brain stimulation (DBS) (Device)
结局指标
主要结局
Modified Rush Video Rating Scale (mRVRS)
时间窗: 12 month
次要结局
- Tourette Syndrome Symptom List (TSSL)(12 month)
- SF-36(12 month)
研究者
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