Evaluation of Memory and Forgetting in Patients With Epilepsy

NCT04924933 | Completed

• 2 other identifiers: 69HCL21_02642021-A01075-36
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epilepsy

Keywords

Temporal lobe epilepsy; Episodic memory; Accelerated long-term forgetting

Outcome Measures

Primary Outcomes (1)

• Evaluation of memory loss

  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 Outcomes (6)

• Evaluation of episodic memory

  30 minutes and 72 hours

• Qualitative distribution of errors at 30-minutes and 72-hours recalls

  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

  30 minutes and 72 hours

• Relevance of a simple recognition to assess episodic memory at 30 minutes and 72 hours

  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

  72 hours

Study Arms (2)

Patients (Epilepsy group)

EXPERIMENTAL

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

Healthy volunteers (control group)

ACTIVE COMPARATOR

Age-matched healthy volunteers

Diagnostic Test: Computerised associative memory task using abstract words and landscape photographs

Interventions

Computerised associative memory task using abstract words and landscape photographs DIAGNOSTIC_TEST

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.

Healthy volunteers (control group); Patients (Epilepsy group)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)
• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon Service de Neurologie Fonctionnelle et d'Epileptologie

Bron, 69500, France

Location

MeSH Terms

Conditions

Epilepsy; Epilepsy, Temporal Lobe

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsies, Partial; Epileptic Syndromes

Study Officials

• Victoria Guinet, PhD student

  Service de Neurologie Fonctionnelle et d'Epileptologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 14, 2021
• Study Start: January 26, 2022
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-01

Locations

FR (1)