NCT00993291已完成1 期
Effect of Frequency Change in Bilateral Subthalamic Nucleus (STN)-DBS on Gait Function in PD
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Stride Length From Baseline
研究概览
简要总结
In this study the investigators will evaluate the effect of both low and high frequency Deep Brain stimulation of the subthalamic nucleus (STN) in Parkinson's patients who have noted a change in their walking. The investigators' hypothesis is:
- Stimulation at 60 Hertz (Hz) is associated with improved gait with increased stride length and faster time on the Stand walk sit test.
- There is no worsening of the Unified Parkinson's Disease Rating Scale (UPDRS) at 60 Hz.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be a patient at the Vanderbilt Movement Disorders clinic.
- •Report a change in their gait.
- •Be able to walk independently when off PD medications for 12-16 hours.
- •Have a stable dose of PD medications for the prior three months .
- •Not cognitively impaired, so as to give informed consent.
- •MMSE > 24.
排除标准
- •See inclusion criteria.
结局指标
主要结局
Change in Stride Length From Baseline
时间窗: 1 hour
Evaluation performed after DBS frequency setting changed for one hour, compared to the subject's baseline DBS frequency stride length
次要结局
- Gait Velocity(5 hours)
- Time to Walk 14 Meters(5 hours)
研究者
研究点 (2)
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