Intraoperative Brain Microdialysis to Assess Neuroinflammation in Epileptic Tissue Immediately Prior to Surgical Resection.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Detection of analytes/protein
研究概览
简要总结
This research study will investigate the fluid from the area of the brain that is being removed during clinical epilepsy surgery. The goal is to analyze this fluid for inflammatory markers that can potentially help identify new strategies in the future to control seizures in individuals with epilepsy who fail to respond to currently available drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Failure to respond to at least two trials of anti-seizure drugs with different mechanisms of action
- •Normal MRI
排除标准
- •Active immunomodulatory therapy
- •Autoimmune disorder
- •Signs or symptoms consistent with comorbid infection
- •Oncological comorbidity
研究组 & 干预措施
drug-resistant temporal lobe epilepsy
Our current standard practice is to use a lateral approach through the middle temporal gyrus to place 3 depth electrodes targeting the hippocampus for intraoperative verification of pathological epileptiform activity prior to resection. Our research protocol will add one FDA approved electrode that has a central cannula for insertion of a microdialysis probe. The electro-physiological data that will be gathered is not altered and this methodology will not impact standard clinical care, except and will not to extend the duration in the OR - the measurements will occur during the clinical electrocorticography (ECoG; intracranial electroencephalography (iEEG)) procedure by 15 min.
干预措施: Intraoperative brain microdialysis (Procedure)
结局指标
主要结局
Detection of analytes/protein
时间窗: Through study completion, up to 5 years
Presence of protein in the microdialysate
次要结局
未报告次要终点
研究者
Charles L. Howe
Principal Investigator
Mayo Clinic
