Study of Predictive Biomarkers for Rational Management of Drug-resistant Epilepsy Associated With Focal Cortical Dysplasia
NCT03321240 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 240
Last updated 2019-06-24
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
- PROCEDURE
-
visual and quantitative SEEG signal analysis
signal SEEG analysis
- PROCEDURE
-
Resective epilepsy surgery procedure
Surgical removal of the epileptogenic brain area
Sponsors & Collaborators
-
University Hospital, Strasbourg, France
lead OTHER
Eligibility
- Min Age
- 2 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-01-15
- Primary Completion
- 2022-12-15
- Completion
- 2022-12-15
Countries
- France
Study Locations
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