Episodic Memory Before and After Surgery in Drug-resistant Partial Epilepsies (MemO-Epi)

February 5, 2015 updated by: Institut National de la Santé Et de la Recherche Médicale, France

Etude de la mémoire Avant et après Chirurgie d'Une épilepsie Partielle pharmacorésistante : Bases Neurobiologiques, Applications Cliniques

This study has two purposes: firstly, a better understanding of the neurobiological processes underlying episodic memory and, secondly, the development of useful clinical applications for epileptic patients, in particular the prediction of postoperative memory deficits and the development of cognitive remediation therapies.

Memory performances during a fMRI experiment will be assessed in controls and epileptic patients before and after the surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

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 Contact

Study Contact Backup

Study Locations

  • France
    • Cedex 13
      • Paris, Cedex 13, France, 75651
        • Recruiting
        • INSERM - Plateau IRM du CENIR, CR-ICM Hôpital Pitié-Salpêtrière, 47/83 Boulevard de l'Hôpital
        • Sub-Investigator:
          • Stéphane Lehéricy, MD, PhD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sophie Dupont, MD, PhD
        • Sub-Investigator:
          • Virginie Lambrecq, MD
        • Sub-Investigator:
          • Véra Dinkelacker, MD
        • Sub-Investigator:
          • Lionel Thivard, MD, PhD
        • Sub-Investigator:
          • Claude Adam, MD, PhD

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with drug-resistant epilepsy
  • Age of 18 years or more
  • Follow-up in the epilepsy unit at Pitié-Salpêtrière Hospital
  • Before or after the presurgical evaluation unit including a video-EEG monitoring, a structural brain imaging and a full neuropsychological assessment
  • Covered by a social security system
  • Signing of consent form

Exclusion Criteria:

  • Persons under guardianship, curatorship or any other administrative or judicial deprivation of rights and freedom
  • Refusal to consent form
  • Contraindications to MRI
  • Pregnancy
  • Refusal to be informed in the case of detection of an abnormality during the experiment

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
No Intervention: memory outcome
Other: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of successfull encoding
Time Frame: 8 years
Our goal is to define correlation between the measure of successfull object encoding trials (especially for binding) and the beta value activation in fMRI
8 years

Collaborators and Investigators

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

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Sophie Dupont, MD, PhD, Service de Soins de Suites et Réadaptation Neurologique, Hôpital de la Pitié-Salpêtrière, 47/83 Bd de l'Hôpital, 75651 Paris Cedex 13

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

October 1, 2013

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

July 1, 2013

First Submitted That Met QC Criteria

August 7, 2013

First Posted (Estimate)

August 9, 2013

Study Record Updates

Last Update Posted (Estimate)

February 6, 2015

Last Update Submitted That Met QC Criteria

February 5, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C12-11
  • 2013-A00343-42 (Registry Identifier: C12-11)

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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