Status:
UNKNOWN
Study of Predictive Biomarkers for Rational Management of Drug-resistant Epilepsy Associated With Focal Cortical Dysplasia
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Refractory Epilepsy
Focal Epilepsy
Eligibility:
All Genders
2+ years
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 15 2022
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03321240
Start Date
January 15 2018
End Date
December 15 2022
Last Update
June 24 2019
Active Locations (11)
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1
Michallon Hospital
Grenoble, France, 38043
2
Hôpital Roger Salengro
Lille, France, 59037
3
Hospices Civils de Lyon
Lyon, France, 69001
4
Timone Hospital
Marseille, France, 13005