December 19, 2017

SPREAD Clinical Trial: Study of Predictive Biomarkers for Rational Management of Drug-resistant Epilepsy Associated With Focal Cortical Dysplasia (SPREAD)

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 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.