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

Memory Impairment Clinical Trial

— MemO-Epi  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01919957
• Other study ID #: C12-11
• Secondary ID: 2013-A00343-42
• Status: Recruiting
• Phase: N/A
• First received: July 1, 2013
• Last updated: February 5, 2015
• Start date: October 2013
• Est. completion date: December 2022

Study information

• Verified date: February 2015
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Sophie DUPONT, MD, PhD
• Phone: 01 42 17 85 23
• Email: sophie.dupont[@]psl.aphp.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Unspecified, Pharmacologically Resistant
• Memory Impairment

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
France	INSERM - Plateau IRM du CENIR, CR-ICM Hôpital Pitié-Salpêtrière, 47/83 Boulevard de l'Hôpital	Paris	Cedex 13

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 years	No