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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01919957
First received: July 1, 2013
Last updated: August 7, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Epilepsy, Unspecified, Pharmacologically Resistant
Memory Impairment
Other: No intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Etude de la mémoire Avant et après Chirurgie d'Une épilepsie Partielle pharmacorésistante : Bases Neurobiologiques, Applications Cliniques

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Measure of successfull encoding [ Time Frame: 8 years ] [ Designated as safety issue: No ]
    Our goal is to define correlation between the measure of successfull object encoding trials (especially for binding) and the beta value activation in fMRI


Estimated Enrollment: 120
Study Start Date: August 2013
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: memory outcome Other: No intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01919957

Contacts
Contact: Sophie DUPONT, MD, PhD 01 42 17 85 23 ext +33 sophie.dupont@psl.aphp.fr
Contact: Virginie LAMBRECQ, MD vlambrecq@hotmail.fr

Locations
France
INSERM - Plateau IRM du CENIR, CR-ICM Hôpital Pitié-Salpêtrière, 47/83 Boulevard de l'Hôpital Not yet recruiting
Paris, Cedex 13, France, 75651
Contact: Sophie Dupont, MD, PhD    01 42 17 85 23 ext +33    sophie.dupont@psl.aphp.fr   
Contact: Virginie Lambrecq, MD       vlambrecq@hotmail.fr   
Principal Investigator: Sophie Dupont, MD, PhD         
Sub-Investigator: Virginie Lambrecq, MD         
Sub-Investigator: Véra Dinkelacker, MD         
Sub-Investigator: Stéphane Lehéricy, MD, PhD         
Sub-Investigator: Lionel Thivard, MD, PhD         
Sub-Investigator: Claude Adam, MD, PhD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01919957     History of Changes
Other Study ID Numbers: C12-11, 2013-A00343-42
Study First Received: July 1, 2013
Last Updated: August 7, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
epilepsy
surgery
functional MRI
memory outcome

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014