NCT03907319终止不适用
Retrospective Multi-Site Re-Evaluation of the MRI Defined STN and Its Correlation to Motor Outcomes With Stimulation Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Incidence of DBS Lead Location in Proximity to STN
研究概览
简要总结
Retrospective review of images used to target the STN during DBS procedure and ability of the Surgical Information Sciences ("SIS") system to visualize the STN location.
详细描述
The purpose of this study is to collect retrospective data to demonstrate the ability of the SIS system to visualize the MRI-defined STN in patients with Parkinson's Disease (PD) who have undergone deep brain stimulation (DBS) procedure targeting the STN.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic PD
- •Bilateral or unilateral STN-HFS for PD
- •40% improvement response to medications preoperatively
排除标准
- •Missing required MR/CT imaging data
结局指标
主要结局
Incidence of DBS Lead Location in Proximity to STN
时间窗: Day 1
Determine incidence in which the location of the DBS lead is in or outside the STN
Percent of STN Visualization Success
时间窗: Day 1
Measure the proportion of images successfully processed for visualization of the STN over total number of image sets
次要结局
- Rate of Correlation of Predicted Outcome to Monopolar Review Outcome(1 Month)
- Rate of Correlation of DBS Lead Location to Long Term Outcomes(3-6 months)
研究者
研究点 (1)
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