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

Primary Purpose

Epilepsy, Unspecified, Pharmacologically Resistant, Memory Impairment

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

No intervention

About this trial

This is an interventional basic science trial for Epilepsy, Unspecified, Pharmacologically Resistant focused on measuring epilepsy, surgery, functional MRI, memory outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

INSERM - Plateau IRM du CENIR, CR-ICM Hôpital Pitié-Salpêtrière, 47/83 Boulevard de l'HôpitalRecruiting

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

memory outcome

Arm Description

Outcomes

Primary Outcome Measures

Measure of successfull encoding

Our goal is to define correlation between the measure of successfull object encoding trials (especially for binding) and the beta value activation in fMRI

Secondary Outcome Measures

Full Information

NCT ID

NCT01919957

First Posted

July 1, 2013

Last Updated

February 5, 2015

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT01919957

Brief Title

Episodic Memory Before and After Surgery in Drug-resistant Partial Epilepsies

Acronym

MemO-Epi

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Unknown status

Study Start Date

October 2013 (undefined)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

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

Epilepsy, Unspecified, Pharmacologically Resistant, Memory Impairment

Keywords

epilepsy, surgery, functional MRI, memory outcome

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

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

memory outcome

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

No intervention

Primary Outcome Measure Information:

Title

Measure of successfull encoding

Description

Our goal is to define correlation between the measure of successfull object encoding trials (especially for binding) and the beta value activation in fMRI

Time Frame

8 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

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

Sophie DUPONT, MD, PhD

Phone

01 42 17 85 23

Ext

+33

sophie.dupont@psl.aphp.fr

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

Virginie LAMBRECQ, MD

vlambrecq@hotmail.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sophie Dupont, MD, PhD

Organizational Affiliation

Service de Soins de Suites et Réadaptation Neurologique, Hôpital de la Pitié-Salpêtrière, 47/83 Bd de l'Hôpital, 75651 Paris Cedex 13

Official's Role

Principal Investigator

Facility Information:

Facility Name

INSERM - Plateau IRM du CENIR, CR-ICM Hôpital Pitié-Salpêtrière, 47/83 Boulevard de l'Hôpital

City

Paris

State/Province

Cedex 13

ZIP/Postal Code

75651

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sophie Dupont, MD, PhD

Phone

01 42 17 85 23

Ext

+33

sophie.dupont@psl.aphp.fr

First Name & Middle Initial & Last Name & Degree

Virginie Lambrecq, MD

vlambrecq@hotmail.fr

First Name & Middle Initial & Last Name & Degree

Sophie Dupont, MD, PhD

First Name & Middle Initial & Last Name & Degree

Virginie Lambrecq, MD

First Name & Middle Initial & Last Name & Degree

Véra Dinkelacker, MD

First Name & Middle Initial & Last Name & Degree

Stéphane Lehéricy, MD, PhD

First Name & Middle Initial & Last Name & Degree

Lionel Thivard, MD, PhD

First Name & Middle Initial & Last Name & Degree

Claude Adam, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Episodic Memory Before and After Surgery in Drug-resistant Partial Epilepsies

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