Epilepsy Lobe TemporalEPINAVIGNCT06847152
Spatial Memory and Temporal Lobe Epilepsy
A study testing spatial memory test in people with Epilepsy Lobe Temporal and Healthy, run by Centre Hospitalier Metropole Savoie at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy Lobe Temporal, Healthy, Epilepsy
- What is being tested?
- spatial memory test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 26 Feb 2025to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Epilepsy Lobe Temporal, Healthy, Epilepsy
- Being tested
- spatial memory test
- Keywords
- epilespsy, lobe temporal, spatial memory, navigation task, accelerated forgetting
- Medical subject headings
- Epilepsy, Temporal Lobe, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy participant | Experimental | spatial memory test to healthy participant Receives: Diagnostic Test: spatial memory test |
| Epileptic patient | Experimental | spatial memory test to epileptic patient Receives: Diagnostic Test: spatial memory test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Test performance is evaluated by completion time (TR) and number of correct responses (BR).
Measured: 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
Test performance is evaluated by completion time (TR) and number of correct responses (BR).
Measured: at 1 hour and 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start26 Feb 2025
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy Lobe TemporalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Metropole Savoie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847152
- Sponsor's protocol ID
- 2024-A02751-46
- Acronym
- EPINAVIG
- Status last verified
- Oct 2026
- First submitted
- 21 Feb 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Memory and Temporal Lobe Epilepsy
- ClinicalTrials.gov ID
- NCT06847152
- Acronym / sponsor ID
- EPINAVIG / 2024-A02751-46
- Conditions
- Epilepsy Lobe Temporal, Healthy, Epilepsy
- Keywords
- epilespsy, lobe temporal, spatial memory, navigation task, accelerated forgetting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Metropole SavoieUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy participant | Experimental | Diagnostic Test: spatial memory testspatial memory test to healthy participant |
| Epileptic patient | Experimental | Diagnostic Test: spatial memory testspatial memory test to epileptic patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- healthy volunteers meeting each of the following criteria:
- Aged over 18 years
- Right-handed*
- Free of known neurological pathology
- Signed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spatial memory testThe 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 | Diagnostic test | Epileptic patient, Healthy participant |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Epilepsy Lobe Temporal
RecruitingObservational study
Investigating Epilepsy: Screening and Evaluation
Seizures, Epilepsy
RecruitingObservational study
Surgery as a Treatment for Medically Intractable Epilepsy
Epilepsy, Epilepsy, Temporal Lobe
Recruiting
Overnight TI in TLE
Temporal Lobe Epilepsy (TLE), Drug Resistant Epilepsy
RecruitingEarly Phase 1
Pharmacological Modulation of Brain Oscillations in Memory Processing
Epilepsy, Seizures
Not yet recruitingObservational study
Studying Heart Rhythms With a Wearable Sensor to Detect and Predict Seizures in People With Epilepsy
Epilepsy, Temporal Lobe, Drug Resistant Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spatial memory test in people with Epilepsy Lobe Temporal and Healthy, run by Centre Hospitalier Metropole Savoie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.