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

Primary Purpose

Epilepsy

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

MRI exam

About this trial

This is an interventional basic science trial for Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CHU Grenoble-AlpesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

epileptic Patients

Arm Description

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03543267

First Posted

May 14, 2018

Last Updated

August 4, 2023

Sponsor

University Hospital, Grenoble

Collaborators

Laboratoire de Psychologie et NeuroCognition

1. Study Identification

Unique Protocol Identification Number

NCT03543267

Brief Title

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

Acronym

FaisPLASTICITE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 21, 2017 (Actual)

Primary Completion Date

December 21, 2024 (Anticipated)

Study Completion Date

December 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Grenoble

Collaborators

Laboratoire de Psychologie et NeuroCognition

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

epileptic Patients

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

MRI exam

Intervention Description

MRI before and after resection surgery

Primary Outcome Measure Information:

Title

Description

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

Time Frame

One hour and thirty minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Emilie Cousin, PhD

Phone

00334.76.82.58.91

emilie.cousin@univ-grenoble-alpes.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Monica BACIU, PhD

Organizational Affiliation

Centre National de la Recherche Scientifique, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Grenoble-Alpes

City

Grenoble

ZIP/Postal Code

38043

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emilie Cousin, PhD

First Name & Middle Initial & Last Name & Degree

Monica Baciu, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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