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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-15

Study Completion Date

2022-12-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Refractory Epilepsy Focal Epilepsy Focal Cortical Dysplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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The SEEG group

Group with the SEEG analysis

visual and quantitative SEEG signal analysis

Intervention Type PROCEDURE

Surgical removal of the epileptogenic brain area

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No