Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Walking Speed
研究概览
简要总结
The purpose of this study is to evaluate the effect of Deep Brain stimulation (DBS) on walking in patients with Parkinson's disease that have had DBS. While DBS improves Parkinson's disease (PD) symptoms and walking in many patients in some of the patients walking problems persist. This study aims to find out what are the best stimulation parameters of the DBS in order to improve walking.
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
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with idiopathic Parkinson's disease stage 1-3 that underwent subthalamic nucleus (STN) Deep Brain Stimulation (DBS) and have walking difficulties 6-12 months after DBS.
- •On stable dose of dopaminergic drugs
- •Age 45-70 years of age
排除标准
- •Past medical history of seizures
- •Renal insufficiency
- •Cardiac arrhythmia
- •Severe arthritis
- •Women of childbearing potential
- •Less than 45 years of age or older than 70 years of age
研究组 & 干预措施
Bilateral stimulation
Participants will receive Deep Brain Stimulation Bilaterally.
干预措施: Deep Brain Stimulator (Device)
Left stimulation
Participants will receive Deep Brain Stimulation on the left side only
干预措施: Deep Brain Stimulator (Device)
Right stimulation
Participants will receive Deep Brain Stimulation on the right side only
干预措施: Deep Brain Stimulator (Device)
Off stimulation
Participants will receive no brain stimulation
结局指标
主要结局
Walking Speed
时间窗: Up to 1 hour
Walking speed will be measured using sensors reported in meter per second.
次要结局
- UPDRS Scores(Up to 1 hour)
- Stride Length(Up to 1 hour)
- TUG Test(Up to 1 hour)
研究者
Corneliu C Luca
Assistant Professor of Neurology
University of Miami