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CompletedNCT03543267FaisPLASTICITEUpdated Jun 13, 2025

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

An interventional study of MRI exam in Epilepsy, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-13.

Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Oct 2017, registered May 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Epilepsy
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 37 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 816 studies on the registry; 206 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    epileptic Patients

    Other: MRI exam

Interventions

  • OtherMRI exam

    MRI before and after resection surgery

06

What researchers measure

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

    Time frame: One hour and thirty minutes

07

Study locations

1 site
  • CHU Grenoble-Alpes
    Grenoble, 38043, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03543267
Lead sponsor
University Hospital, Grenoble
Collaborators
Laboratoire de Psychologie et NeuroCognition
Responsible party
Sponsor
First posted
Jun 1, 2018
Start date
Oct 21, 2017
Primary completion
Jul 5, 2022
Completion
Jul 5, 2022
Last update
Jun 13, 2025

Study contacts

Monica BACIU, PhD
principal investigator · Centre National de la Recherche Scientifique, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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