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Completed

NCT Number: NCT03543267

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Grenoble-Alpes

Grenoble, 38043, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI exam

Other

MRI before and after resection surgery

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.

    Time frame: One hour and thirty minutes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Laboratoire de Psychologie et NeuroCognition

Registry information

Official study title

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

Acronym: FaisPLASTICITE

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jun 1, 2018
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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