Subthalamic Nucleus Stimulation Effect on Gait Symmetry and Freezing of Gait
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- improvement of Freezing of gait
研究概览
简要总结
Impact of unilateral modulation of deep brain stimulation of the subthalamic nucleus on freezing of gait in Parkinson's disease
详细描述
Unilateral modulation of subthalamic stimulation and its impact on freezing of gait in Parkinson's disease will be studied.
In a cross-over, doubleblind, randomized study, a 30% reduction of stimulation intensity of the less impacted side will be compared with chronic treatment with regard to frequency and duration of freezing of gait episodes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients affiliated to social security Patient with idiopathic parkinson's disease, with deep brain stimulation since at least one year Freezing of gait Able to give inform consent
排除标准
- •Patient under guardianship, legal guardianship Psychosis Severe depression Severe cognitive troubles (Mattis < 130) Other neurologic or medical pathology interfering with gait
研究组 & 干预措施
Chronic Subthalamic nucleus stimulation
This arm is the reference, with the best stimulation parameters
干预措施: Chronic Subthalamic nucleus stimulation (Procedure)
Unilateral reduction of stimulation
30% unilateral reduction of Subthalamic nucleus stimulation
干预措施: Unilateral reduction of stimulation (Procedure)
结局指标
主要结局
improvement of Freezing of gait
时间窗: 1 month after new stimulation parameters
the improvement will be measure with a composite score of items 12 + 13 on UPDRS II and items 10+11 on UPDRS III,
次要结局
未报告次要终点