Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy: New Targets for Diagnosis and Prediction of Drug Resistance
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Epilepsy |
Other: blood sampling for drug resistance biomarkers |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy: New Targets for Diagnosis and Prediction of Drug Resistance |
- Comparison of Biomarkers [ Time Frame: 12 months after inclusion (day 0) ] [ Designated as safety issue: No ]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
- permeability of the blood-brain barrier [ Time Frame: Day 0 ] [ Designated as safety issue: No ]Compare changes in lesion morphologic imaging and blood flow measurements by Magnetic Resonance Imaging between the two groups
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Antiepileptic Drug resistant
Adult patients suffering from epilepsy drug-resistant and potentially surgical candidates
|
Other: blood sampling for drug resistance biomarkers
comparison of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy
|
|
Experimental: Antiepileptic drug Controlled group
epilepsy well controlled by antiepileptic drugs
|
Other: blood sampling for drug resistance biomarkers
comparison of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Arielle CRESPEL, MD | 04 67 33 72 40 | a-crespel@chu-montpellier.fr |
| France | |
| UH Montpellier | Recruiting |
| Montpellier, France, 34295 | |
| Contact: Arielle CRESPEL, MD 04 67 33 72 40 a-crespel@chu-montpellier.fr | |
| Principal Investigator: Arielle CRESPEL, MD | |
| Sub-Investigator: Philippe GELISSE, MD | |
More Information
No publications provided
| Responsible Party: | University Hospital, Montpellier |
| ClinicalTrials.gov Identifier: | NCT01563627 History of Changes |
| Other Study ID Numbers: | 8668 |
| Study First Received: | March 9, 2012 |
| Last Updated: | March 26, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Epilepsy Epilepsy, Temporal Lobe Brain Diseases Central Nervous System Diseases Nervous System Diseases Epilepsies, Partial |
Anticonvulsants Immunologic Factors Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013