NCT00169338已完成2 期
Pallidal Stimulation in Patients With Post-anoxic and Idiopathic Dystonia
Marie-laure Welter1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2005年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
研究概览
简要总结
Bilateral pallidal stimulation is effective in the treatment of patients with generalised idiopathic dystonia. The aim of this study is to evaluate the efficacy of bilateral pallidal stimulation in patients with post-anoxic generalised dystonia or non-generalised primary dystonia.
详细描述
Evaluate the effect of bilateral pallidal stimulation on the motor disability of patients with post-anoxic generalised dystonia or primary dystonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 65 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-anoxic generalised dystonia
- •Idiopathic non-generalised dystonia
- •Disease duration > 1 year
排除标准
- •Contraindication to magnetic resonance imaging (MRI)
- •Mini-mental status (MMS) < 24
- •Severe psychiatric disorder
研究组 & 干预措施
deep brain stimulation
Experimental
Paladin deep brain stimulation
干预措施: Deep brain stimulation (Procedure)
sham deep brain stimulation
Placebo Comparator
no stimulation
研究者
Marie-laure Welter
MD, PhD
Groupe Hospitalier Pitie-Salpetriere
研究点 (1)
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