Effect of Deep Brain Stimulation on Gait of Patients With Parkinson's Disease Depending on Electrode Location in Subthalamic Area.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- The step length (expressed in meter)
研究概览
简要总结
Deep brain stimulation of STN (subthalamic nucleus) at high frequencies generally improved gait in parkinsonian patients. However, sometimes the investigators observed a gait aggravation either with using high voltage and high frequencies, either because of suboptimal placement of electrode inside Forel H2 field. The most frequent hypothesise to explain this gait aggravation is a modulation of the activity of pedunculopontine nucleus due to a diffusion of the electric stimulation current to the fibbers going near STN area.
The primary purpose of this study is to compare the effect of deep brain stimulation with high frequency versus low frequency on gait of patients whatever the electrodes placement (STN ou Forel fields) and whatever the medication condition (with or without treatment).
详细描述
A randomized, double-blind, parallel-group study 2 groups of patients: 10 patients with electrodes placed in STN and 10 patients with electrodes placed in Forel fields.
1 group of healthy paired-control (n=20).
Patients will be evaluated without and with treatment on two mornings (J0 and J0+1day).
In each condition of treatment, 3 conditions of stimulation were tested: without stimulation; frequency 25Hz, frequency 130 Hz.
Evaluations consist on :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients :
- •Men or women aged between 45 -85 years
- •Patients with an idiopathic Parkinson's disease according to UKPDSBB criteria
- •Normal neurologic evaluation (except Parkinson's disease)
- •Patient treated with a deep brain stimulation according to the French consensus conference of treatment of Parkinson's disease (Consensus Conference Proceeding, 2000)
- •Affiliated to National Health system
- •Having given their informed consent
- •Healthy subject
- •Men or women aged between 45 -85 years
- •Normal neurologic evaluation
- •Affiliated to National Health system
- •Having given their informed consent
排除标准
- •Patients :
- •Patients suffering of an atypical Parkinson syndrome
- •Patients with locomotive disorders which can interfere in gait evaluation
- •Patients with dementia (MMS <24)
- •Under guardianship
- •In excluding period for another study
- •Person who participate to an other study
- •Healthy subject
- •Subject with locomotive disorders which can interfere in gait evaluation
- •Subject with dementia (MMS <24)
- •Under guardianship
- •In excluding period for another study
结局指标
主要结局
The step length (expressed in meter)
时间窗: from day 1 (without L Dopa) to day 2 (with L Dopa)
次要结局
- The step cadence(From day 1 (without L Dopa) to day 2 (with L Dopa))
- The number of freezing(from day 1 (without L Dopa) to day 2 (with L Dopa))
- The gait speed(from day 1 (without L Dopa) to day 2 (with L Dopa))
- The UPDRS score(from day 1 (without L Dopa) to day 2 (with L Dopa))