Spatial Memory and Temporal Lobe Epilepsy
EPINAVIG
1 other identifier
interventional
37
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2025
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
February 26, 2025
CompletedStudy Start
First participant enrolled
February 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2025
CompletedSeptember 22, 2025
September 1, 2025
9 months
February 21, 2025
September 16, 2025
Conditions
Keywords
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
EXPERIMENTALspatial memory test to healthy participant
Epileptic patient
EXPERIMENTALspatial memory test to epileptic patient
Interventions
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
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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