Predictive Factors for Therapeutic Response of Subthalamic Stimulation on Quality of Live in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 试验地点
- 16
- 主要终点
- Improve of quality of life on PDQ39>20%
研究概览
简要总结
This study identify preoperative predictors of response to subthalamic stimulation at 1 year, 3 years and 5 years in terms of quality of life, from a broad prospective multicenter study French with standardized collection of clinical data , imaging and genetic .
The investigators want to identify factors that predict the improvement of quality of life for one year corresponding to a decrease of PDQ39 score of at least 20 %. They believe that improvement would be less likely to become zero to 3 or 5 years and question the indication of the subthalamic stimulation (risks and costs). This is part of a process of "personalization" of the therapeutic care that is of any interest to the subthalamic stimulation. It is a therapeutic option that could be dangerous if patient selection is not optimal , and expensive, if the benefit is not large enough to reduce the number of medications and hospitalizations medium term . In addition, it will quantify the improvement of quality of life in the longer term and harmonize national assessments .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving a pre- therapeutic assessment and therapeutic monitoring for one year , 3 years and 5 years as part of the regular monitoring of the subthalamic stimulation
- •Bilateral STN stimulation considered
- •Patient able to provide their free and informed consent
- •Patient with insurance coverage
排除标准
- •Atypical Parkinson's disease do not meet the criteria of stuff .
- •MP under 5 years
- •Severe cognitive impairment or dementia ( Score Moca <24 and DSM-IV criteria)
- •Parkinson's Psychosis
- •Reply to L- dopa <30 %
- •Against indication for surgery
- •Severe brain atrophy or abnormal MRI
- •The presence of another very serious condition terminal life- short-term prognosis ( malignancy ) is an indication against .
研究组 & 干预措施
patients with Parkinson's disease
Large population of Parkinson's patients who benefit from subthalamic stimulation
干预措施: patients with Parkinson's disease (Other)
结局指标
主要结局
Improve of quality of life on PDQ39>20%
时间窗: 1 year
次要结局
- Percentage of motor score MDS-UPDRS III improve under stimulation(1 year)
- Socio-familial evolution (institutionalization)(1, 3 and 5 years)
- Clinical Global Impression of Patient by 7-point scale(1, 3 and 5 years)
- Clinical Global Impression of doctor by 7-point scale(1, 3 and 5 years)
- Death(1, 3 and 5 years)
- Cognitive function with a neuropsychological examination(1, 3 and 5 years)
- Behavior test(1, 3 and 5 years)
- Motor response rates to Levodopa(1, 3 and 5 years)
- Non-motor functions evaluated by a numerical evaluation scale(screening and at 1, 3 and 5 years)