Web-based International Multi-Center Clinical Study for Parkinson's Disease; the Evaluation of Clinical Outcome Based on the Electrode Position Estimated From the Fused Images of Preoperative MRI and Postoperative CT After Bilateral STN DBS
试验速览
- 阶段
- 不适用
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- To determine the electrode positions with the relationship of the STN from the fused images of the preoperative MRI and the postoperative CT
研究概览
简要总结
The objectives of this study are (1) to compare the clinical outcome in correlation with the electrode positions estimated by web-based image fusion of the preoperative MRI and the postoperative brain CT taken at a stable period after surgery using mutual information technique in the patients with advanced Parkinson's disease (PD) after bilateral STN DBS and (2) to examine whether the documentation of the electrode position by using mutual information technique at a stable period after unilateral or bilateral STN stimulation provides useful information for the postoperative programming.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced Parkinson Disease patients
排除标准
- •The patients who have experienced any perioperative or postoperative complications
- •The patients with severe cognitive impairment, ongoing psychiatric problems, an unsatisfactory general condition for evaluation, or an inability
结局指标
主要结局
To determine the electrode positions with the relationship of the STN from the fused images of the preoperative MRI and the postoperative CT
时间窗: at 1 month after surgery
次要结局
- UPDRS, H&Y, ADL scores, LEDD(at 6 and 12 months after surgery)