Study of Predictive Biomarkers for Rational Management of Drug-resistant Epilepsy Associated With Focal Cortical Dysplasia

Last updated: June 20, 2019
Sponsor: University Hospital, Strasbourg, France
Overall Status: Active - Recruiting

Phase

N/A

Condition

Epilepsy

Epilepsy (Pediatric)

Treatment

N/A

Clinical Study ID

NCT03321240
6647
  • Ages > 2
  • All Genders

Study Summary

Focal Cortical Dysplasias (FCDs) are neurodevelopmental disorders that represent a major cause of early onset drug-resistant epilepsies with cognitive and behavioral impairments, carrying a lifelong perspective of disability and reduced quality of life. Despite a major medical and socio-economic burden, rationale therapeutic strategies are still under debate. Surgical removal of the epileptogenic brain area (Epileptogenic Zone) is the most successful treatment, yet it fails to control FCD-associated seizures in as much as 40% of cases. Precise definition and complete resection of the Epileptogenic Zone are the main determinants of outcome. In current practice of French centers, up to 80% FCD-patients require an intracranial EEG (icEEG) recording to accurately define the epileptogenic zone. However, the indications for icEEG in MRI-visible FCD remain empirical and are essentially based on expert opinion.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult or pediatric patient suffering from drug-resistant focal epilepsy;

  • Age more than 2 years old;

  • Brain MRI suggestive of FCD or normal;

  • Standardized presurgical evaluation available including medical history, scalpvideo-EEG, 3T MRI, FDG-PET, Neuropsychological tests;

  • Inpatient in one of the participating centers for recording seizure during long termscalp video-EEG and / or SEEG-monitoring;

  • Resective surgery with a minimal post-operative follow-up of 12 months;

  • Histopathologic evidence for FCD or non-pathologic findings (normal histology or mMCDtype II).

  • Patient, parents or legally representative who have given written informed consent toallow the study data collection procedures.

Exclusion

Exclusion Criteria:

  • Brain MRI suggestive of another type of lesion;

  • Difficulty to read or understand French, or inability to understand the information;

  • Pregnant or breastfeeding woman;

  • Subject under judicial protection.

  • Other lesion discovered on histological examination;

  • FCD type 3, dual pathology, ambiguous or unavailable neuropathological findings

  • Lack of longitudinal pre- and post-surgical follow-up.

Study Design

Total Participants: 240
Study Start date:
January 15, 2018
Estimated Completion Date:
December 15, 2022

Connect with a study center

  • Michallon Hospital

    Grenoble, 38043
    France

    Active - Recruiting

  • Hôpital Roger Salengro

    Lille, 59037
    France

    Active - Recruiting

  • Hospices Civils de Lyon

    Lyon, 69001
    France

    Active - Recruiting

  • Timone Hospital

    Marseille, 13005
    France

    Active - Recruiting

  • University Hospital of Nancy

    Nancy, 54000
    France

    Active - Recruiting

  • GH Pitie-Salpêtrière-Charles Foix

    Paris, 75013
    France

    Active - Recruiting

  • Necker-Enfants Malades Hospital

    Paris, 75015
    France

    Active - Recruiting

  • Rothschild Foundation

    Paris, 75019
    France

    Active - Recruiting

  • CHU Rennes

    Rennes, 35000
    France

    Active - Recruiting

  • Les Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091
    France

    Active - Recruiting

  • Hôpital Pierre Paul Riquet

    Toulouse, 31059
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.