Convection Enhanced Delivery of Autologous Cerebral Spinal Fluid Improves MRI Visualizations of Basal Ganglion Nuclei During Deep Brain Stimulation Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Number of Participants With Adverse Events That Are Related to Treatment
研究概览
简要总结
This study will evaluate safety foremost but also the distribution and initial effectiveness of infusion-enhanced, MRI-guided DBS for patients with medication-refractory, Parkinson's disease
详细描述
This is an open-label, single-arm, pilot study investigating the safety and feasibility of infusion-enhanced, MRI-guided DBS electrode placement. The investigators intend to enroll patients with Parkinson's disease and medically-refractory motor symptoms, who are already planned for MRI-guided DBS electrodes under general anesthesia. The hypothesis of the study is that a convective micro-infusion of autologous CSF will enhance the T2-weighted MRI visualization of the targeted nucleus during image-guided DBS surgery for Parkinson's disease. The investigators will record standard clinical measures of PD at baseline and 6 months following DBS surgery. The study will recruit patients at a rate of approximately one a month and will take less than two years to complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, age 30 years and older
- •Subjects with advanced PD who are scheduled for MRI-guided DBS surgery under general anesthesia
- •Subjects who are able and willing to give informed consent and able to attend clinic visits through 6 months
- •The target nucleus, GPi or STN, is visible on MRI so that it can be targeted for the study infusion and then for MRI-guided DBS
排除标准
- •DBS surgery planned in the awake condition with microelectrode recordings and clinical testing
- •Spinal pathology not amenable to lumbar puncture
- •Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
- •Legal incapacity or limited legal capacity as determined by the neuropsychologist
- •Are participating or have participated in another clinical trial in the last 30 days
- •Any illness that in the investigator's opinion preclude participation in this study.
结局指标
主要结局
Number of Participants With Adverse Events That Are Related to Treatment
时间窗: 6 months postoperatively
Safety will be determined by an evaluation of the incidence and severity of infusion-related side effects and complications from the first treatment day visit through the 6-month post-treatment time point. All AEs will be reported and categorized by investigators as definitely, probably, possibly, unlikely, or unrelated to the CSF infusion, and/or Parkinson's disease progression. Safety will be assessed by incidence and severity of AEs, including changes in physical examinations and neurological examinations, and the number of discontinuations due to AEs.
次要结局
- % Change in Un-medicated UPDRS, Motor Subsection (Part III) From Baseline to 6 Months(6 months postoperatively in comparison to baseline)
- Change in Quality of Life Assessment With PDQ-39 Questionnaire(6 months postoperatively in comparison to baseline)
- Vd/Vi Ratio(Day of Surgery)
- Baseline Levodopa Medication Equivalents (Milligrams)(Baseline)
研究者
Jeff Elias, MD
Professor of Neurological Surgery
University of Virginia