Focal Cortical Dysplasia, Focal Epilepsy, Refractory Epilepsy
Conditions
Keywords
focal cortical dysplasia, Pronostic, Epilepsy surgery, Epiletogenicity index, SEEG
Brief 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.
Interventions
PROCEDUREvisual and quantitative SEEG signal analysis
signal SEEG analysis
PROCEDUREResective epilepsy surgery procedure
Surgical removal of the epileptogenic brain area
Sponsors
University Hospital, Strasbourg, France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of seizure-free patients (Engel class I) at 12-months follow-up after resective surgery. | 12 month |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of each of six seizure-onset pattern types within each of three histologically defined subgroups (FCD type I, FCD type II, non-pathologic findings). | 12 month |
| Duration of epilepsy before surgery in patients with focal and network epileptogenic zone (defined by EI) | 12 month |
| Topographic distribution of structures that disclose high Epileptogenicity Index values (EI>0.4), of structures with maximal interictal HFO rates and of structures showing interictal/preictal functional connectivity alterations | 12 month |
Countries
France
Contacts
Primary ContactEdouard HIRSCH
Backup ContactJulia SCHOLLY
Outcome results
None listed