NCT01919957

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 9, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 6, 2015

Status Verified

February 1, 2015

Enrollment Period

8.2 years

First QC Date

July 1, 2013

Last Update Submit

February 5, 2015

Conditions

Keywords

epilepsysurgeryfunctional MRImemory outcome

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

memory outcome

NO INTERVENTION
Other: No intervention

Interventions

memory outcome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Paris, Cedex 13, 75651, France

RECRUITING

MeSH Terms

Conditions

EpilepsyMemory Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie DUPONT, MD, PhD

CONTACT

Virginie LAMBRECQ, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2013

First Posted

August 9, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

February 6, 2015

Record last verified: 2015-02

Locations