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临床试验/NCT01563627
NCT01563627已完成不适用

Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy: New Targets for Diagnosis and Prediction of Drug Resistance

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2011年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Comparison of Biomarkers

研究概览

简要总结

Epilepsy affects 0.7% of the general population and 15-20% of patients develop drug resistance. The temporal lobe epilepsy (TLE) is the most common symptomatic focal epilepsies with a particularly high rate of drug (about 20 to 30%). In this type of epilepsy, where feasible, surgical removal of the home is the best therapeutic outcome.

Mechanisms of epileptogenesis and drug resistance are still mysterious. Of recent clinical and experimental studies have shown that dysfunction of the blood-brain barrier (BBB) contributes to epileptogenesis and drug resistance. It is now recognized that cytokines exacerbate the excitability and permeability of the BBB, which was recently confirmed by studies showing that treatment of inflammation reduces epileptogenesis. Moreover, we have described an association between pathological angiogenesis and BBB permeability in the tissue of patients with excision of drug-resistant TLE. With experimental models, it was revealed an activation of the VEGF-VEGFR2 by seizures leading to rapid degradation of the BBB.

The investigators hypothesis is that the identification of factors involved in BBB permeability may designate potential targets for drug-resistant partial epilepsy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient with temporal lobe epilepsy (TLE)
  • •Patient with epilepsy for at least two years. Arm 1: Patient with drug-resistant TLE proved potentially a candidate for surgery.
  • •Arm 2: Patient with TLE seizure-free for 12 months or more

排除标准

  • •Patient with a scalable general pathology may lead to increased inflammatory markers: neoplasia, chronic inflammatory diseases etc. ...
  • •Patient with neurological history other than epilepsy with evolutionary potential or likely to interfere with the inflammatory markers

研究组 & 干预措施

Antiepileptic Drug resistant

Experimental

Adult patients suffering from epilepsy drug-resistant and potentially surgical candidates

干预措施: blood sampling for drug resistance biomarkers (Other)

Antiepileptic Drug resistant

Experimental

Adult patients suffering from epilepsy drug-resistant and potentially surgical candidates

干预措施: Magnetic Resonance Imaging (Device)

Antiepileptic drug Controlled group

Experimental

epilepsy well controlled by antiepileptic drugs

干预措施: blood sampling for drug resistance biomarkers (Other)

Antiepileptic drug Controlled group

Experimental

epilepsy well controlled by antiepileptic drugs

干预措施: Magnetic Resonance Imaging (Device)

结局指标

主要结局

Comparison of Biomarkers

时间窗: 12 months after inclusion (day 0)

Identify blood sampling biomarkers of drug resistance in temporal lobe epilepsy, an analysis by large-scale expression profiling of serum factors involved in inflammation, immunity and angiogenesis

次要结局

  • permeability of the blood-brain barrier(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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