NCT01081457已完成不适用
Effect of Deep Brain Stimulation on Voluntary and Involuntary Gastrointestinal Motility in Parkinson's Disease
University Hospital, Rouen2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2010年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Anal pressure
研究概览
简要总结
Parkinson's disease is characterized by extra-pyramidal symptoms as well as digestive involvement with gastrointestinal motility (GI) impairment. Deep brain stimulation has been recently developed as a successful treatment for extrapyramidal symptoms. In addition, preliminary reports suggest that this therapy might be successful to relieve GI symptoms as well. The aim of this study is therefore to assess the effect of deep brain stimulation on GI voluntary as well as involuntary motility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
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
- •patient over 18 yo
- •patient with Parkinson's disease implanted for deep brain stimulation
- •patient responders to deep brain stimulation (UPDRS improved by at least 40%)
- •patient covered by the french health care system
- •patient not taking anti-parkinsonian medication the day before evaluation
- •French speaking
排除标准
- •patient below 18 yo
- •pregnancy
- •Severe psychiatric or cognitive disorders
- •diabetes mellitus
- •morbid obesity
- •compulsive eating disorders
- •diffuse GI motility impairment (except Parkinson's disease)
- •other evolutive neurologic disorders
- •previous history of significant GI resection
- •inability to swallow or defecate when asked
结局指标
主要结局
Anal pressure
时间窗: 2 hours
次要结局
未报告次要终点
研究者
Guillaume GOURCEROL
MD
University Hospital, Rouen
研究点 (2)
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