Spinal Cord Stimulation in the Treatment of Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- improvement in walking capacity
研究概览
简要总结
Parkinson's disease affects between 100'000 and 150'000 people in France. Drug therapy (L-Dopa and other drugs) is effective to improve motor symptoms but after an initial 'honeymoon period' lasting a few years, motor symptoms reoccur in most patients, impairing gait and walking.
Spinal cord stimulation is currently an important therapeutic option in the treatment of neuropathic pain. Experimental and limited clinical data suggest that this technique might also be used to alleviate motor symptoms and improve walking in Parkinsons patients.
This exploratory study aims at measuring the benefits of spinal cord stimulation on the walking capacity of a small number of Parkinsons patients who are not adequately improved by drug therapy alone.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's disease since more than 5 years
- •Walking disorder with freezing episodes, insufficiently alleviated by oral dopaminergic therapy and/or physiotherapy
排除标准
- •Atypical Parkinson-like syndrome (e.g. progressive supranuclear palsy)
- •Cognitive impairment (MMSE<24)
- •Psychiatric disease
- •Contraindication of surgery
- •Neuropathic pain in the lower limb or lumbar region
研究组 & 干预措施
Spinal cord stimulation
干预措施: spinal cord stimulation (St Jude Medical) (Device)
结局指标
主要结局
improvement in walking capacity
时间窗: 2 months
"stand-walk-sit" test : time to complete the test : difference between scores pre-implantation and 2 month post-implantation of stimulator
次要结局
- improvement in "freezing of gait" score(2 months)
- freezing episodes : reduction of cumulated time(2 months)
- freezing episodes : reduction of frequency(2 months)
- improvement in motor score of MultiDimentionalScaling-UPDRS scale(2 months)
- improvement in quality of life score(2 months)