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

• Conditions: Refractory Epilepsy; Focal Cortical Dysplasia; Focal Epilepsy
• Interventions: Procedure: visual and quantitative SEEG signal analysis; Procedure: Resective epilepsy surgery procedure

• Registration Number: NCT03321240
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-16
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-25
• Study Start: 2018-01-15
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-20
• Last Update Posted: 2019-06-24
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The SEEG group	Resective epilepsy surgery procedure	Group with the SEEG analysis
The direct surgery group	Resective epilepsy surgery procedure	Group with a direct surgery
The SEEG group	visual and quantitative SEEG signal analysis	Group with the SEEG analysis

Primary Outcome Measures

Name	Time	Method
Percentage of seizure-free patients (Engel class I) at 12-months follow-up after resective surgery.	12 month

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (11)

Timone Hospital; 🇫🇷 Marseille, France

GH Pitie-Salpêtrière-Charles Foix; 🇫🇷 Paris, France

Rothschild Foundation; 🇫🇷 Paris, France

Michallon Hospital; 🇫🇷 Grenoble, France

CHU Rennes; 🇫🇷 Rennes, France

Les Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

Necker-Enfants Malades Hospital; 🇫🇷 Paris, France

University Hospital of Nancy; 🇫🇷 Nancy, France

Hôpital Pierre Paul Riquet; 🇫🇷 Toulouse, France

Hôpital Roger Salengro; 🇫🇷 Lille, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France