Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy

Not Applicable

Completed

• Conditions: Epilepsy
• Interventions: Other: blood sampling for drug resistance biomarkers; Device: Magnetic Resonance Imaging

• Registration Number: NCT01563627
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-03-09
• Study First Submitted QC: 2012-03-26
• Study First Posted: 2012-03-27
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-31
• Last Update Posted: 2016-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antiepileptic drug Controlled group	Magnetic Resonance Imaging	epilepsy well controlled by antiepileptic drugs
Antiepileptic Drug resistant	blood sampling for drug resistance biomarkers	Adult patients suffering from epilepsy drug-resistant and potentially surgical candidates
Antiepileptic Drug resistant	Magnetic Resonance Imaging	Adult patients suffering from epilepsy drug-resistant and potentially surgical candidates
Antiepileptic drug Controlled group	blood sampling for drug resistance biomarkers	epilepsy well controlled by antiepileptic drugs

Primary Outcome Measures

Name	Time	Method
Comparison of Biomarkers	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

Secondary Outcome Measures

Name	Time	Method
permeability of the blood-brain barrier	Day 0	Compare changes in lesion morphologic imaging and blood flow measurements by Magnetic Resonance Imaging between the two groups

Trial Locations

Locations (1)

UH Montpellier; 🇫🇷 Montpellier, France