- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06847152
Spatial Memory and Temporal Lobe Epilepsy (EPINAVIG)
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jacqueline BOUCHET
- Phone Number: +33479965161
- Email: jacqueline.bouchet@ch-metropole-savoie.fr
Study Contact Backup
- Name: Fabienne Prieur
- Phone Number: +33479965999
- Email: fabienne.prieur@ch-metropole-savoie.fr
Study Locations
-
-
Savoie
-
Chambéry, Savoie, France, 73011
- Recruiting
- Centre Hospitalier Metropole Savoie
-
Contact:
- Jacqueline BOUCHET
- Phone Number: +33479965999
- Email: jaqcueline.bouchet@ch-metropole-savoie.fr
-
Principal Investigator:
- Jacqueline BOUCHET
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHMS24007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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