NCT06847152

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 26, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2025

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

February 21, 2025

Last Update Submit

September 16, 2025

Conditions

Keywords

epilespsylobe temporalspatial memorynavigation taskaccelerated forgetting

Outcome Measures

Primary Outcomes (1)

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

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

    1 hour and 6 weeks

Secondary Outcomes (2)

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

    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

    at 1 hour and 6 weeks.

Study Arms (2)

Healthy participant

EXPERIMENTAL

spatial memory test to healthy participant

Diagnostic Test: spatial memory test

Epileptic patient

EXPERIMENTAL

spatial memory test to epileptic patient

Diagnostic Test: spatial memory test

Interventions

spatial memory testDIAGNOSTIC_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

Epileptic patientHealthy participant

Eligibility Criteria

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

You may qualify if:

  • \- 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Métropole Savoie

Chambéry, Savoie, 73011, France

RECRUITING

MeSH Terms

Conditions

Epilepsy, Temporal LobeEpilepsy

Condition Hierarchy (Ancestors)

Epilepsies, PartialBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic Syndromes

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2025

First Posted

February 26, 2025

Study Start

February 26, 2025

Primary Completion

November 12, 2025

Study Completion

November 12, 2025

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations