Clinical trial NCT03321240: Study of Predictive Biomarkers for Rational Management of Drug-resistant Epilepsy Associated With Focal Cortical Dysplasia
Official title: Study of Predictive Biomarkers for Rational Management of Drug-resistant Epilepsy Associated With Focal Cortical Dysplasia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Refractory Epilepsy
Focal Epilepsy
Focal Cortical Dysplasia
Keywords: focal cortical dysplasia
Pronostic
Epilepsy surgery
Epiletogenicity index
SEEG
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 240
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of seizure-free patients (Engel class I) at 12-months follow-up after resective surgery.
timeFrame: 12 month
Secondary outcomes:
measure: 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).
timeFrame: 12 month
measure: Duration of epilepsy before surgery in patients with focal and network epileptogenic zone (defined by EI)
timeFrame: 12 month
measure: 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
timeFrame: 12 month
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Michallon Hospital
city: Lille
country: France
facility: Hôpital Roger Salengro
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: Timone Hospital
city: Nancy
country: France
facility: University Hospital of Nancy
city: Paris
country: France
facility: GH Pitie-Salpêtrière-Charles Foix
city: Paris
country: France
facility: Necker-Enfants Malades Hospital
city: Paris
country: France
facility: Rothschild Foundation
city: Rennes
country: France
facility: CHU Rennes
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
city: Toulouse
country: France
facility: Hôpital Pierre Paul Riquet
Study officials:
References: