NCT03321240

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	visual and quantitative SEEG signal analysis	signal SEEG analysis
PROCEDURE	Resective epilepsy surgery procedure	Surgical removal of the epileptogenic brain area

Timeline

• Start date: 2018-01-15
• Primary completion: 2022-12-15
• Completion: 2022-12-15
• First posted: 2017-10-25
• Last updated: 2019-06-24

Locations

11 sites across 1 country: France