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Completed

NCT Number: NCT06847152

Spatial Memory and Temporal Lobe Epilepsy

Temporal lobe epilepsy (TLE) can cause memory disorders, including long-term forgetfulness due to a failure to consolidate verbal but also spatial information. The forgetting phenomenon presented by these epileptic patients is called accelerated forgetting in the literature and remains difficult to objectify during cognitive assessments. It is indeed particularly complicated to evaluate long-term spatial memory and to account for the topographical complaint, although recurrent, of patients with this TLE.

A navigation task being proposed as part of the neuropsychological assessment of patients with a spatial memory complaint, it is interesting to study the performance pattern of patients with TLE by comparing them to a group of control subjects matched in age and gender in order to verify whether there is significant long-term forgetting and whether there is a significant difference between Right TLE and Left TLE. Indeed, several studies have demonstrated this accelerated long-term forgetting in epileptic patients (Cassel et al., 2016; Lemesle et al., 2017; Landry et al., 2022; Blake et al., 2020) but few with a retention delay of several weeks (Tramoni et al., 2009). This study allows us to statistically analyze the effects of these two groups: epileptic patients and healthy volunteers, but also to combine the effect of the laterality of epilepsy specifically on spatial memory performance.

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Key information

Conditions

Epilepsy Lobe Temporal Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Epilepsy, Temporal Lobe Epileptic Syndromes Healthy Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Métropole Savoie

Chambéry, Savoie, 73011, France

About this study

In order to assess the long-term spatial memory capacities of epileptic patients with memory complaints, a navigation task was proposed as part of the neuropsychological assessment. This task corresponds to learning a route within the hospital. It is composed of a learning phase and then the patient is asked to repeat the route one hour later and then six weeks later, in order to check for the presence or absence of long-term forgetting. We wanted to study the results of patients with temporal lobe epilepsy (TLE) by comparing them to a group of healthy volunteers matched in age and gender in order to check whether there is significant long-term forgetting and whether there is a significant difference between Right TLE and Left TLE. This study therefore aims to statistically analyze the effects of these two groups: epileptic patients and healthy volunteers, but also to combine the effect of the laterality of epilepsy specifically on spatial memory performance. It will also be interesting to observe whether there is a difference between men and women in the healthy volunteer group for spatial memory learning.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy volunteers meeting each of the following criteria:
  • Aged over 18 years
  • Right-handed*
  • Free of known neurological pathology
  • Signed consent
  • Matched in age (+ or - 5 years) and gender with epileptic patients presenting the characteristics below:
  • Right-handed*
  • adult
  • presenting temporal lobe epilepsy, whose lateralization of the epileptogenic focus (right or left) has been objectified by an examination (EEG and/or MRI),
  • having carried out a neuropsychological assessment including the navigation task,
  • having been informed of the study, and consenting to the processing of their data

Exclusion criteria

  • Person referred to in Article L1121-5 of the Public Health Code: Pregnant, parturient, or breastfeeding women
  • Person referred to in Article L1121-6 of the Public Health Code: persons deprived of their judicial or administrative freedom
  • Person referred to in Article L1121-8 of the Public Health Code: persons subject to a legal protection measure or unable to express their consent
  • Person referred to in Article L1121-8-1 of the Public Health Code: persons not affiliated to a social security scheme
  • Left-handed participants
  • Participants familiar with the premises of the Centre Hospitalier Métropole Savoie
  • Not speaking French

Exclusion criteria

Patients who have undergone epilepsy neurosurgery between the initial visit and the secondary visit of the neuropsychological assessment will not be paired with a healthy volunteer. Their data will not be studied.

Volunteers whose pretest scores reveal a cognitive disorder (pathological threshold > 1.65) will not perform the navigation task. They will then be referred to a neurologist.

Treatment and study plan

spatial memory test

Diagnostic Test

The assessment of spatial memory corresponds in our study to a navigation task, i.e. learning a route through the hospital. The route encoding phase is first carried out. The participant follows the experimenter, with the instruction to pay close attention to the route in order to be able to do it again alone. For directions, it is said "this way" or "that way" and not "left" or "right". The route includes 18 intersections.

The participant immediately does the route again alone. The number of correct answers (BR), i.e. correct directions taken at each intersection, is counted as well as the time to complete the route (TR). Direction errors are corrected. This is recall 1.

The participant is then asked to do the route a second time. The correct answers and the times to complete the route are recorded. Errors are corrected (feedback). This is recall 2.

If the participant makes a mistake on recall 1 or 2, a third attempt is made. This is recall 3.

After an interval of 1 hour, the partic

Primary outcomes

  1. Changes of the number of correct responses from 1h to 6 weeks, compared between healthy volunteers and epileptic patients

    Time frame: 1 hour and 6 weeks

    The number of correct responses is defined as the number of intersections correctly crossed.

Secondary outcomes

  1. Changes in test performance from 1h to 6 weeks, compared according to epileptogenic focus (right or left) lateralization.

    Time frame: at 1 hour and 6 weeks.

    Test performance is evaluated by completion time (TR) and number of correct responses (BR).

  2. Changes in test performance from 1h to 6 weeks, compared between male and female in the healthy volunteers group

    Time frame: at 1 hour and 6 weeks.

    Test performance is evaluated by completion time (TR) and number of correct responses (BR).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Metropole Savoie

Other

Registry information

Acronym: EPINAVIG

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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