Study on Neurocognitive Plasticity in Patients With Focal and Drug-resistant Epilepsy

Not Applicable

Recruiting

• Conditions: Epilepsy
• Interventions: Other: MRI exam

• Registration Number: NCT03543267
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-21
• Study First Submitted: 2018-05-14
• Study First Submitted QC: 2018-05-31
• Study First Posted: 2018-06-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-04
• Last Update Posted: 2023-08-07
• Primary Completion: 2024-12-21
• Study Completion: 2024-12-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
epileptic Patients	MRI exam	-

Primary Outcome Measures

Name	Time	Method
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.	One hour and thirty minutes	The outcome measure is the hemispheric lateralization index (IL) before surgery measured by functional MRI

Trial Locations

Locations (1)

CHU Grenoble-Alpes; 🇫🇷 Grenoble, France