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
- 1
- 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.
研究组 & 干预措施
Intracerebral Infusion of Autologous CSF
All subjects will receive the intracerebral infusion of autologous cerebral spinal fluid (CSF) during their deep brain stimulation (DBS) surgery. The DBS surgery will be performed on the targeted nucleus either bilaterally or unilaterally, as previously determined by a multidisciplinary team of neurology, neurosurgery, and neuropsychology. During unilateral DBS surgery, the targeted nucleus will be infused using convection enhanced delivery (CED). The nondominant side will be infused during a bilateral DBS procedure.
干预措施: Intracerebral Infusion of Autologous Cerebral Spinal Fluid (Device)
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