Feasibility Study on Neurocognitive Plasticity in Patients With Focal and Drug-resistant Epilepsy, Before and After Surgery. Evaluation by Functional and Anatomic Neuroimaging

University Hospital, Grenoble1 site in 1 country37 target enrollmentOctober 21, 2017

ConditionsEpilepsy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Epilepsy
Sponsor: University Hospital, Grenoble
Enrollment: 37
Locations: 1
Primary Endpoint: to define anatomo-functional reorganization (plasticity) profiles by functional MRI for the mentioned cognitive functions, before surgery (chronic plasticity induced by the epileptogenic zone) in patients with drug-resistant epilepsy.
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study consist of define anatomo-functional reorganization (plasticity) profiles for the mentioned cognitive functions, before surgery (chronic plasticity induced by the epileptogenic zone) in patients with drug-resistant epilepsy.

For that, patients will have 2 MRI examinations, one before surgery and the second, between 3 and 8 months after surgery.

Registry

clinicaltrials.gov

Start Date

October 21, 2017

End Date

July 5, 2022

Last Updated

10 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Grenoble

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with diagnosis of pharmaco-resistant focal epilepsy
•Patient candidate for surgery to resect the epileptogenic zone
•Patients affiliated to a social security scheme or beneficiaries of such a scheme
•Patients with French as their mother tongue
•Patients who have given signed informed consent before performing any procedure related to the study.

Exclusion Criteria

•Contraindication to performing an MRI:
•Intellectual disability objectified by a Mini Mental Score (MMS) score \<24 in the year preceding inclusion,
•Existence of a severe condition in general: cardiac, respiratory, hematological, renal, hepatic, cancerous,
•Participation in other research protocols underway with exclusion period or in the previous week,
•Persons referred to in Articles L1121-5 to L1121-8 of the Public Health Code.

Outcomes

Primary Outcomes

to define anatomo-functional reorganization (plasticity) profiles by functional MRI for the mentioned cognitive functions, before surgery (chronic plasticity induced by the epileptogenic zone) in patients with drug-resistant epilepsy.

Time Frame: One hour and thirty minutes

The outcome measure is the hemispheric lateralization index (IL) before surgery measured by functional MRI