Deep Brain Stimulation of the Cuneiform Nucleus for Levodopa-resistant Freezing of Gait in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Percent change in UPDRS Part III on/off stimulation
研究概览
简要总结
The purpose of this research study is to determine if DBS is a safe and effective therapy for severe freezing of gait in patients with Parkinson's Disease. Freezing of gait (FOG) is a particularly debilitating motor deficit seen in a subset of patients with Parkinson's Disease (PD).
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
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percent change in UPDRS Part III on/off stimulation
时间窗: Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op
Percent change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III on/off stimulation across study visits relative to pre-operative assessment
Percent Change in Gait Velocity
时间窗: Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op
Percent change in gait velocity with and without bilateral cuneiform nucleus deep brain stimulation. Over a distance of 3 meters, gait velocity will be measured using the timed Up and Go test instrumented with Mobility Lab accelerometers.
次要结局
- Percent Change in Muscle Amplitude(Baseline, 24 weeks)
- Percent Change in number of Falls(Baseline, 24 weeks)
- Percent Change in PDQ 39(Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op)
- Percent Change in PDQ-L(Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op)
- Percent Change in FOG Questionnaire(Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op)
研究者
Jonathan Jagid
Associate Professor of Neurological Surgery, Neurology, Orthopedics, and Rehabilitation
University of Miami