Studying Stepping Control in Parkinson's Disease Using Alternating DBS
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Stepping control will be assessed as the ability to adjust the stepping speed (m/s) in each stimulation condition.
研究概览
简要总结
Parkinson's disease (PD) is a disabling, progressive condition characterised by severe problems with movement for which medical treatment in the longer term can be unsatisfactory. Deep brain stimulation (DBS) is a treatment, which directly stimulates the nerve cells affected inside the brain to help overcome the difficulties with movement. Classically, DBS stimulates in a manner that is constant. Many patients develop severe problems with walking, so-called freezing of gait, which can be unresponsive to constant DBS. In this study the investigators will test if left-right alternating DBS helps to improve gait problems by potentially promoting left-right alternating up- and down-modulated brain activity, which was found during walking in a previous study. The investigators will test if alternating DBS improves the ability to adjust walking speed and to walk freely compared to constant DBS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Participants and the UPDRS examiner are blinded to the stimulation condition.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PD patients with bilateral subthalamic nucleus DBS electrodes and stimulators implanted for at least 6 months
- •Able to give consent.
排除标准
- •Lack of capacity to consent
- •Cognitive impairment/lack of capacity to perform experimental task. The investigators will additionally conduct a short (10 min) quantitative assessment of cognitive function using a validated test (MMSE). Patients with a score < 20 will be excluded from the study.
研究组 & 干预措施
Within-subjects comparison of constant and alternating DBS
干预措施: Alternating DBS (Device)
结局指标
主要结局
Stepping control will be assessed as the ability to adjust the stepping speed (m/s) in each stimulation condition.
时间窗: Immediate recording
Stepping speed (m/s) will be assessed.
Stepping control will be assessed as the ability to limit the variance in stepping speed (m/s) in each stimulation condition.
时间窗: Immediate recording
Stepping variance (m/s) will be assessed.
次要结局
- The investigators will test if patients automatically adjust to the stimulation rhythm(Immediate recording)
- The investigators will how well other motor symptoms including tremor, rigidity and bradykinesia are controlled with alternating DBS.(Immediate recording)