Evaluation of Memory and Forgetting in Patients With Epilepsy (EPIMNESIE)

May 30, 2025 updated by: Hospices Civils de Lyon

Evaluation of Episodic Memory and Accelerated Long-term Forgetting in Patients With Drug-resistant Focal Epilepsy

Drug-resistant focal epilepsy (DRFE) is frequently associated with complications of varying severity that impair patient's quality of life. Among these complications, cognitive disturbances and especially episodic memory difficulties, play a determinant part. Episodic memory can be defined as a function that allows the mental reconstruction of a past life episode, through complex associative mechanisms that link the vivid experience to its context of occurrence, called encoding context. It is a dynamic cognitive function, which calls on a widely distributed cerebral network, mainly involving the medial temporal lobe, particularly the hippocampus. Epilepsy could have a specific impact on this crucial network, disrupting the binding mechanisms between the experienced events and their encoding context, which are essential for efficient memory. Although patients with DRFE frequently demonstrate memory impairment as assessed by standardised neuropsychological tests, it only imperfectly reflects their difficulties. As a matter of fact, despite a subjective memory complaint, about 20% have no memory impairment on these tests, resulting from a phenomenon called accelerated long-term forgetting (ALF). ALF is indeed characterised by normal performance on standardised neuropsychological tests involving retention delays of 20-30 minutes, but disabling memory complaint and abnormally marked forgetting within hours or days that follow the learning period. This phenomenon is widely described at the conceptual level, but remains difficult to measure in daily practice, at least partly due to methodological limits. Thus, the validated tools available in clinical routine are poorly adapted to the complexity and the associative dimension of memory networks. There is therefore a clinical need for a specific assessment tool that would be able to detect ALF, in order to better quantify it and to enable the appropriate care of patients suffering from DRFE. The aim of the EPIMNESIE study is to evaluate the diagnostic capacity of a behavioural associative memory task, based on the analysis of encoding and consolidation mechanisms, in order to measure ALF. In this prospective study, 40 patients with DRFE and 40 healthy subjects will be proposed to complete a new associative memory task involving a learning phase and two recall sessions which will take place at 30 minutes and 72 hours after the learning phase.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Bron, France, 69500
        • Hospices Civils de Lyon Service de Neurologie Fonctionnelle et d'Epileptologie

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Epilepsy group :

Inclusion Criteria:

  • Adult (≥ 18 years old) suffering from drug-resistant focal epilepsy
  • Patient who recently benefit from a comprehensive neuropsychological assessment (≤2 years)
  • Patient presenting a subjective memory complaint consistent with an ALF
  • Patient who obtained normal performance at memory tests during the comprehensive neuropsychological assessment
  • Patient who gave its written informed consent to participate to the study
  • Patient with corrected or non-corrected visual acuity allowing fluid reading on a computer screen
  • Patient affiliated to the French health care system

Exclusion Criteria:

  • Patient with impaired reading or understanding
  • Patient suffering from a major depressive syndrome (score >15 on the French version of the Neurological Disorders Depression Inventory for Epilepsy - NDDIE)
  • Patient who have undergone epilepsy surgery
  • Patient who presented a seizure within the hour preceding the first test session
  • Protected major
  • Pregnant or breastfeeding woman

Control group

Inclusion Criteria:

  • Adult (≥ 18 years old) without any neurological or psychiatric history
  • Adult who gave its written informed consent to participate to the study
  • Adult with corrected or non-corrected visual acuity allowing fluid reading on a computer screen
  • Adult with normal scores on the Montreal Cognitive Assessment (MoCA) and the Matrix reasoning sub-test of the Fourth Edition Wechsler Adult Intelligence Scale (MoCA ≥ 27/30, Matrix reasoning >5)

Exclusion Criteria:

  • Adult suffering from a depressive syndrome or a significative anxiety (score ≥ 8 in each dimension of the French version of the Hospital Anxiety and Depression Scale - HADS)
  • Adult presenting a spontaneous subjective memory complaint
  • Protected major
  • Pregnant or breastfeeding woman

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients (Epilepsy group)
Patients with drug-resistant focal epilepsy in whom an accelerated long-term forgetting is suspected (presence of a subjective memory complaint and absence of objective deficit in memory tests conducted in the frame of a routine comprehensive neuropsychological assessment)
Diagnostic test: Computerised associative memory task using abstract words and landscape photographs
Two test sessions using the computerised associative memory task will be performed by the two groups (patients and control subjects). The first session will consist of the encoding of 56 associations between a word and a photograph and the recall of half of them (28) 30 minutes later by the mean of a matching task and a recognition task. The second session consists of the recall of the other half of the associations (28) 72 hours after the encoding phase, using the same procedure (matching task and recognition task). Performance obtained by patients and by healthy volunteers will then be compared.
Active Comparator: Healthy volunteers (control group)
Age-matched healthy volunteers
Diagnostic test: Computerised associative memory task using abstract words and landscape photographs
Two test sessions using the computerised associative memory task will be performed by the two groups (patients and control subjects). The first session will consist of the encoding of 56 associations between a word and a photograph and the recall of half of them (28) 30 minutes later by the mean of a matching task and a recognition task. The second session consists of the recall of the other half of the associations (28) 72 hours after the encoding phase, using the same procedure (matching task and recognition task). Performance obtained by patients and by healthy volunteers will then be compared.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of memory loss
Time Frame: 30 minutes and 72 hours
Memory loss 72 hours after the encoding phase compared to the performance obtained at 30 minutes, based on the number of correct hits (CH - calculated on 28 items) obtained at these two moments. The memory loss will be calculated as the difference between the number of CH: CH 30 minutes - CH 72 hours.
30 minutes and 72 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of episodic memory
Time Frame: 30 minutes and 72 hours
Number of correct hits (CH) at 30-minutes and 72-hours in the Epilepsy group compared to the Control group
30 minutes and 72 hours
Qualitative distribution of errors at 30-minutes and 72-hours recalls
Time Frame: 30 minutes and 72 hours
Number of false-alarm errors (FA) involving familiar but non associated items (FNAI) and number of FA involving hybrid items (HI) during the 30-minutes and 72-hours recalls in the Epilepsy group compared to the Control group
30 minutes and 72 hours
Relationship between the extent of forgetting at 30 minutes and 72 hours and the nature of contextual associations during the acquisition phase
Time Frame: 30 minutes and 72 hours
Proportion of FA regarding associations categorized as "not linked" during the encoding phase
30 minutes and 72 hours
Relevance of a simple recognition to assess episodic memory at 30 minutes and 72 hours
Time Frame: 30 minutes and 72 hours
Number of correct recognitions (CR) during the 30-minutes and 72-hours recalls in the Epilepsy group compared to the Control group
30 minutes and 72 hours
Effect of antiepileptic treatment currently taken by the patient (reported through clinical data) on the extent of memory loss assessed at 72 hours
Time Frame: 72 hours
Relation between the number of antiseizure drugs (molecules) currently taken by the patient and available in clinical data and the memory loss (number of correct answers at 30 minutes - number of correct answers at 72 hours)
72 hours
Effect of the usual frequency of seizures reported by the patient through a dedicated agenda on the extent of memory loss assessed at 72 hours
Time Frame: 72 hours
Relation between monthly seizures frequency within the 3 months preceding the inclusion and reported through a dedicated agenda and the memory loss (number of correct answers at 30 minutes - number of correct answers at 72 hours).
72 hours

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Victoria Guinet, PhD student, Service de Neurologie Fonctionnelle et d'Epileptologie

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 26, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 27, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL21_0264
  • 2021-A01075-36 (Other Identifier: IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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