Informations générales (source: ClinicalTrials.gov)
Study of Predictive Biomarkers for Rational Management of Drug-resistant Epilepsy Associated With Focal Cortical Dysplasia (SPREAD)
Observational
University Hospital, Strasbourg, France (Voir sur ClinicalTrials)
janvier 2018
décembre 2022
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Necker-Enfants Malades | KAMINSKA Anna | vendredi 21 juin 2024 | Contact (sur clinicalTrials) | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Rennes - 35000 - Rennes - France | Anca NICA | Contact (sur clinicalTrials) | |||
| GH Pitie-Salpêtrière-Charles Foix - 75013 - Paris - France | Vincent NAVARRO | Contact (sur clinicalTrials) | |||
| Hôpital Pierre Paul Riquet - 31059 - Toulouse - France | Luc VALTON | Contact (sur clinicalTrials) | |||
| Hôpital Roger Salengro - 59037 - Lille - France | William SZURHAJ | Contact (sur clinicalTrials) | |||
| Hospices Civils de Lyon - 69001 - Lyon - France | Sylvain RHEIMS | Contact (sur clinicalTrials) | |||
| Les Hôpitaux Universitaires de Strasbourg - 67091 - Strasbourg - France | Edouard HIRSCH | Contact (sur clinicalTrials) | |||
| Michallon Hospital - 38043 - Grenoble - France | Philippe KAHANE | Contact (sur clinicalTrials) | |||
| Rothschild Foundation - 75019 - Paris - France | Mathilde CHIPAUX, MD | Contact (sur clinicalTrials) | |||
| Timone Hospital - 13005 - Marseille - France | Fabrice BARTOLOMEI | Contact (sur clinicalTrials) | |||
| University Hospital of Nancy - 54000 - Nancy - France | Louis MAILLARD | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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.