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

June 12, 2025 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • CHU Grenoble-Alpes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: epileptic Patients
Other: MRI exam
MRI before and after resection surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One hour and thirty minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Laboratoire de Psychologie et NeuroCognition

Investigators

  • Principal Investigator: Monica BACIU, PhD, Centre National de la Recherche Scientifique, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2017

Primary Completion (Actual)

July 5, 2022

Study Completion (Actual)

July 5, 2022

Study Registration Dates

First Submitted

May 14, 2018

First Submitted That Met QC Criteria

May 31, 2018

First Posted (Actual)

June 1, 2018

Study Record Updates

Last Update Posted (Actual)

June 13, 2025

Last Update Submitted That Met QC Criteria

June 12, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC17.018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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