Effects of Deep Brain Stimulation of the Mesencephalic Locomotor Region on Gait and Balance Disorders in Parkinson's Disease Patients : a Randomized, Double-blind, Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in the anticipatory postural adjustments between each deep brain stimulation condition
研究概览
简要总结
Gait and balance disorders represent the main motor disability in advanced Parkinson's disease. These symptoms are less or unresponsive to levodopa treatment and are considered to be a contraindication for deep brain stimulation of the subthalamic nucleus. Falls and freezing of gait are responsible for high morbidity (fractures, residential health care) and increased significantly mortality. The pathophysiology of gait and balance disorders is still poorly understood, but recent data obtained in animals and humans suggest that a degeneration of cholinergic neurons of the pedunculopontine nucleus (PPN), within the mesencephalic locomotor region, could play a crucial role. In line with this hypothesis, low-frequency stimulation of the pedunculopontine area, thought to increase the activity of the remaining cholinergic PPN neurons, has been proposed to alleviate gait and balance disorders in advanced PD patients. Here, the efficacy of deep brain stimulation of the mesencephalic locomotor region will be tested in 12 PD patients in a randomized, double-blind, cross-over, controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 71 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age below 71 years
- •severe form of Parkinson's Disease with disease duration > 5 years
- •presence of gait and/or balance disorders unresponsive to levodopa treatment,
- •> 40% decrease in others motor symptoms with levodopa treatment
- •health insurance
- •give signed informed written consent
排除标准
- •dementia (Mattis Dementia Rating Scale < 129, MDRS),
- •ongoing psychiatric disturbances,
- •surgical contraindications
- •significant brain lesions detected on MRI.
结局指标
主要结局
Change in the anticipatory postural adjustments between each deep brain stimulation condition
时间窗: 3, 5, 7 months after surgery
次要结局
未报告次要终点
