Spatial Memory and Temporal Lobe Epilepsy (EPINAVIG)

September 16, 2025 updated by: Centre Hospitalier Metropole Savoie

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.

Study Overview

Status

Recruiting

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Savoie
      • Chambéry, Savoie, France, 73011

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy participant
spatial memory test to healthy participant

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

Experimental: Epileptic patient
spatial memory test to epileptic patient

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
at 1 hour and 6 weeks.
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).
at 1 hour and 6 weeks.

Collaborators and Investigators

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

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)

February 26, 2025

Primary Completion (Estimated)

November 12, 2025

Study Completion (Estimated)

November 12, 2025

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

February 26, 2025

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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