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临床试验/NCT04531722
NCT04531722
撤回
不适用

Intraoperative Brain Microdialysis to Assess Neuroinflammation in Epileptic Tissue Immediately Prior to Surgical Resection.

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 3 人2019年3月27日

概览

阶段
不适用
干预措施
Intraoperative brain microdialysis
疾病 / 适应症
Epilepsy
发起方
Mayo Clinic
入组人数
3
试验地点
2
主要终点
Detection of analytes/protein
状态
撤回
最后更新
26天前

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.

注册库
clinicaltrials.gov
开始日期
2019年3月27日
结束日期
2026年1月10日
最后更新
26天前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

发起方
Mayo Clinic
责任方
Principal Investigator
主要研究者

Charles L. Howe

Principal Investigator

Mayo Clinic

入排标准

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

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

研究点 (2)

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