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

Refractory Epilepsy Clinical Trial

— SPREAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03321240
• Other study ID #: 6647
• Status: Recruiting
• Start date: January 15, 2018
• Est. completion date: December 15, 2022

Study information

• Verified date: June 2019
• Source: University Hospital, Strasbourg, France
• Contact: Edouard HIRSCH
• Phone: +33 3 88 12 85 62
• Email: edouard.hirsch[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsies, Partial
• Epilepsy
• Focal Cortical Dysplasia
• Focal Epilepsy
• Hyperplasia
• Refractory Epilepsy

Intervention

Procedure:
• visual and quantitative SEEG signal analysis
signal SEEG analysis
• Resective epilepsy surgery procedure
Surgical removal of the epileptogenic brain area

Locations

Country	Name	City	State
France	Michallon Hospital	Grenoble
France	Hôpital Roger Salengro	Lille
France	Hospices Civils de Lyon	Lyon
France	Timone Hospital	Marseille
France	University Hospital of Nancy	Nancy
France	GH Pitie-Salpêtrière-Charles Foix	Paris
France	Necker-Enfants Malades Hospital	Paris
France	Rothschild Foundation	Paris
France	CHU Rennes	Rennes
France	Les Hôpitaux Universitaires de Strasbourg	Strasbourg
France	Hôpital Pierre Paul Riquet	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of seizure-free patients (Engel class I) at 12-months follow-up after resective surgery.		12 month
Secondary	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
Secondary	Duration of epilepsy before surgery in patients with focal and network epileptogenic zone (defined by EI)		12 month
Secondary	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