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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01563627
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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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.


Condition or disease Intervention/treatment Phase
Epilepsy Other: blood sampling for drug resistance biomarkers Device: Magnetic Resonance Imaging Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Medicines

Arms and Interventions
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Arm Intervention/treatment
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

Device: Magnetic Resonance Imaging
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

Device: Magnetic Resonance Imaging


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of Biomarkers [ Time Frame: 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 :
  1. permeability of the blood-brain barrier [ Time Frame: Day 0 ]
    Compare changes in lesion morphologic imaging and blood flow measurements by Magnetic Resonance Imaging between the two groups


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563627


Locations
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France
UH Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01563627    
Other Study ID Numbers: 8668
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Epilepsy
Epilepsy, Temporal Lobe
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Epilepsies, Partial
Epileptic Syndromes