Effets de la Stimulation cérébrale Profonde Chez Les Patients âgés Avec Maladie de Parkinson : Essai contrôlé randomisé Multicentrique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 14
- 主要终点
- PDQ-39 Quality of life questionnary
研究概览
简要总结
Deep brain stimulation of the sub thalamic nucleus (STN-DBS) is an efficient treatment to improve motor and non motor signs of Parkinson's disease (PD). In people aged more 70 years, an increased rate of side effects such as post-operative cognitive decline and/or postural instability with falls has been suspected with less improvement in the quality of life. Here, Investigators aim further explore the effects of STN-DBS in 50 patients with PD people aged more 69 years in a randomized parallel controlled study.
详细描述
The effects of combined bilateral deep brain stimulation of the subthalamic nucleus and medical treatment on the quality of life will be evaluated in 25 PD patients aged more 69 years in comparison to 25 PD patients aged more 69 years that only received medical drug treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 69 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson's disease
- •disease duration > 5 years
- •levodopa related motor complications
- •dopasensitivity > 50%
- •signed informed written consent
- •medical social insurance
排除标准
- •contra-indication to neurosurgery
结局指标
主要结局
PDQ-39 Quality of life questionnary
时间窗: Quality of life one year after surgery
PDQ-39 : Parkinson's disease quality of life scale questionnaire with 39 questions, grouped into 8 domains. Each item is scored on a scale from 0 to 4, with higher scores indicating greater difficulties. An overall score can be calculated by averaging the eight domain scores. Scores range from 0 to 100 : 0 = best quality of life 100 = worst quality of life
次要结局
未报告次要终点