NCT00196911已完成3 期
Randomized, Multicenter, Prospective, Parallel-Group Study of the Effect of Deep Brain Stimulation (Subthalamic Nucleus) on Quality of Life and Motor Complications in Patients With Advanced Parkinson's Disease Compared With Best Medical Treatment
German Parkinson Study Group (GPS)12 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2001年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 12
- 主要终点
- Motor Score in the OFF (UPDRS III)
研究概览
简要总结
Assessment of the therapeutic effect of deep brain stimulation of the subthalamic nucleus compared with drug treatment alone in patients with advanced Parkinson's disease.
详细描述
Patients are randomized either to medical treatment or subthalamic stimulation. The observation period was 6 months. The primary outcome criterium: PDQ-39 and UPDRS III.
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
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •advanced Parkinson's disease with UPDRS III score >29/104 or Dyskinesia score > 2 or tremor >2
排除标准
- •age>75 years depression psychosis surgical contraindications
结局指标
主要结局
Motor Score in the OFF (UPDRS III)
Quality of life
次要结局
未报告次要终点
研究者
研究点 (12)
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