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

NCT03321240 | Unknown

• 1 other identifier: 6647
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 11

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.

Conditions

Refractory Epilepsy; Focal Epilepsy; Focal Cortical Dysplasia

Keywords

focal cortical dysplasia; Pronostic; Epilepsy surgery; Epiletogenicity index; SEEG

Outcome Measures

Primary Outcomes (1)

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

  12 month

Secondary Outcomes (3)

• 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

Study Arms (2)

The SEEG group

Group with the SEEG analysis

Procedure: visual and quantitative SEEG signal analysis; Procedure: Resective epilepsy surgery procedure

The direct surgery group

Group with a direct surgery

Procedure: Resective epilepsy surgery procedure

Interventions

visual and quantitative SEEG signal analysis PROCEDURE

signal SEEG analysis

The SEEG group

Resective epilepsy surgery procedure PROCEDURE

Surgical removal of the epileptogenic brain area

The SEEG group; The direct surgery group

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult or pediatric (Age more than 2 years old) patients attending tertiary epilepsy center for presurgical evaluation of refractory focal epilepsy compatible with FCD

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (11)

Michallon Hospital

Grenoble, 38043, France

RECRUITING

Hôpital Roger Salengro

Lille, 59037, France

RECRUITING

Hospices Civils de Lyon

Lyon, 69001, France

RECRUITING

Timone Hospital

Marseille, 13005, France

RECRUITING

University Hospital of Nancy

Nancy, 54000, France

RECRUITING

GH Pitie-Salpêtrière-Charles Foix

Paris, 75013, France

RECRUITING

Necker-Enfants Malades Hospital

Paris, 75015, France

RECRUITING

Rothschild Foundation

Paris, 75019, France

RECRUITING

CHU Rennes

Rennes, 35000, France

RECRUITING

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

Hôpital Pierre Paul Riquet

Toulouse, 31059, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample and resected brain tissue specimen

MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsies, Partial; Focal Cortical Dysplasia

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Edouard HIRSCH

CONTACT

+33 3 88 12 85 62; edouard.hirsch@chru-strasbourg.fr

Julia SCHOLLY

CONTACT

+33 3 88 12 85 78; julia.scholly@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 25, 2017
• Study Start: January 15, 2018
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: June 24, 2019

Record last verified: 2019-06

Locations

FR (11)