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

  • STATUS
    Recruiting
  • End date
    Dec 15, 2022
  • participants needed
    240
  • sponsor
    University Hospital, Strasbourg, France
Updated on 23 January 2021
epilepsy
seizure
neuropsychological assessment
epilepsy surgery
electrocorticography
cortical dysplasias

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.

Details
Condition Epilepsy, Epilepsy, Seizure Disorders, Seizure Disorders (Pediatric), Focal epilepsy, Refractory Epilepsy, Intractable Epilepsy, Focal Cortical Dysplasia, Seizure Disorders (Pediatric), Seizure Disorders, partial epilepsy
Treatment visual and quantitative SEEG signal analysis, Resective epilepsy surgery procedure
Clinical Study IdentifierNCT03321240
SponsorUniversity Hospital, Strasbourg, France
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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, scalp video-EEG, 3T MRI, FDG-PET, Neuropsychological tests
Inpatient in one of the participating centers for recording seizure during long term scalp 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 mMCD type II)
Patient, parents or legally representative who have given written informed consent to allow the study data collection procedures

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
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