NCT03543267

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 21, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2022

Completed
Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

4.7 years

First QC Date

May 14, 2018

Last Update Submit

June 12, 2025

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • 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

    One hour and thirty minutes

Study Arms (1)

epileptic Patients

EXPERIMENTAL
Other: MRI exam

Interventions

MRI examOTHER

MRI before and after resection surgery

epileptic Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Contraindication to performing an MRI:
  • Existence of a severe condition in general: cardiac, respiratory, hematological, renal, hepatic, cancerous,
  • Persons referred to in Articles L1121-5 to L1121-8 of the Public Health Code.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Grenoble-Alpes

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Monica BACIU, PhD

    Centre National de la Recherche Scientifique, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2018

First Posted

June 1, 2018

Study Start

October 21, 2017

Primary Completion

July 5, 2022

Study Completion

July 5, 2022

Last Updated

June 13, 2025

Record last verified: 2025-06

Locations

FR(1)