EpilepsyEPIMNESIENCT04924933
Evaluation of Memory and Forgetting in Patients With Epilepsy
A study testing Computerised associative memory task using abstract words and landscape photographs in people with Epilepsy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Drug-resistant focal epilepsy (DRFE) is frequently associated with complications of varying severity that impair patient's quality of life. Among these complications, cognitive disturbances and especially episodic memory difficulties, play a determinant part. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Computerised associative memory task using abstract words and landscape photographs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2022to 27 May 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult (≥ 18 years old) suffering from drug-resistant focal epilepsy
- Patient who recently benefit from a comprehensive neuropsychological assessment (≤2 years)
- Patient presenting a subjective memory complaint consistent with an ALF
- Patient who obtained normal performance at memory tests during the comprehensive neuropsychological assessment
- Patient who gave its written informed consent to participate to the study
- Patient with corrected or non-corrected visual acuity allowing fluid reading on a computer screen
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- Patient affiliated to the French health care system
- Adult (≥ 18 years old) without any neurological or psychiatric history
- Adult who gave its written informed consent to participate to the study
- Adult with corrected or non-corrected visual acuity allowing fluid reading on a computer screen
- Adult with normal scores on the Montreal Cognitive Assessment (MoCA) and the Matrix reasoning sub-test of the Fourth Edition Wechsler Adult Intelligence Scale (MoCA ≥ 27/30, Matrix reasoning >5)
Who cannot join
- Patient with impaired reading or understanding
- Patient suffering from a major depressive syndrome (score >15 on the French version of the Neurological Disorders Depression Inventory for Epilepsy - NDDIE)
- Patient who have undergone epilepsy surgery
- Patient who presented a seizure within the hour preceding the first test session
- Protected major
- Pregnant or breastfeeding woman
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- Control group
- Adult suffering from a depressive syndrome or a significative anxiety (score ≥ 8 in each dimension of the French version of the Hospital Anxiety and Depression Scale - HADS)
- Adult presenting a spontaneous subjective memory complaint
- Protected major
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon Service de Neurologie Fonctionnelle et d'Epileptologie
Bron, 69500
About this study
Official title: Evaluation of Episodic Memory and Accelerated Long-term Forgetting in Patients With Drug-resistant Focal Epilepsy
Drug-resistant focal epilepsy (DRFE) is frequently associated with complications of varying severity that impair patient's quality of life. Among these complications, cognitive disturbances and especially episodic memory difficulties, play a determinant part. Episodic memory can be defined as a function that allows the mental reconstruction of a past life episode, through complex associative mechanisms that link the vivid experience to its context of occurrence, called encoding context. It is a dynamic cognitive function, which calls on a widely distributed cerebral network, mainly involving the medial temporal lobe, particularly the hippocampus. Epilepsy could have a specific impact on this crucial network, disrupting the binding mechanisms between the experienced events and their encoding context, which are essential for efficient memory. Although patients with DRFE frequently demonstrate memory impairment as assessed by standardised neuropsychological tests, it only imperfectly reflects their difficulties. As a matter of fact, despite a subjective memory complaint, about 20% have no memory impairment on these tests, resulting from a phenomenon called accelerated long-term forgetting (ALF). ALF is indeed characterised by normal performance on standardised neuropsychological tests involving retention delays of 20-30 minutes, but disabling memory complaint and abnormally marked forgetting within hours or days that follow the learning period. This phenomenon is widely described at the conceptual level, but remains difficult to measure in daily practice, at least partly due to methodological limits. Thus, the validated tools available in clinical routine are poorly adapted to the complexity and the associative dimension of memory networks. There is therefore a clinical need for a specific assessment tool that would be able to detect ALF, in order to better quantify it and to enable the appropriate care of patients suffering from DRFE. The aim of the EPIMNESIE study is to evaluate the diagnostic capacity of a behavioural associative memory task, based on the analysis of encoding and consolidation mechanisms, in order to measure ALF. In this prospective study, 40 patients with DRFE and 40 healthy subjects will be proposed to complete a new associative memory task involving a learning phase and two recall sessions which will take place at 30 minutes and 72 hours after the learning phase.
- Conditions
- Epilepsy
- Being tested
- Computerised associative memory task using abstract words and landscape photographs
- Keywords
- Temporal lobe epilepsy, Episodic memory, Accelerated long-term forgetting
- Medical subject headings
- Epilepsy, Epilepsy, Temporal Lobe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerised associative memory task using abstract words and landscape photographsDiagnostic test
Two test sessions using the computerised associative memory task will be performed by the two groups (patients and control subjects). The first session will consist of the encoding of 56 associations between a word and a photograph and the recall of half of them (28) 30 minutes later by the mean of a matching task and a recognition task. The second session consists of the recall of the other half of the associations (28) 72 hours after the encoding phase, using the same procedure (matching task and recognition task). Performance obtained by patients and by healthy volunteers will then be compared.
| Study group | Role | What they receive |
|---|---|---|
| Patients (Epilepsy group) | Experimental | Patients with drug-resistant focal epilepsy in whom an accelerated long-term forgetting is suspected (presence of a subjective memory complaint and absence of objective deficit in memory tests conducted in the frame of a routine comprehensive neuropsychological assessment) Receives: Diagnostic Test: Computerised associative memory task using abstract words and landscape photographs |
| Healthy volunteers (control group) | Active comparator | Age-matched healthy volunteers Receives: Diagnostic Test: Computerised associative memory task using abstract words and landscape photographs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of memory loss
Memory loss 72 hours after the encoding phase compared to the performance obtained at 30 minutes, based on the number of correct hits (CH - calculated on 28 items) obtained at these two moments. The memory loss will be calculated as the difference between the number of CH: CH 30 minutes - CH 72 hours.
Measured: 30 minutes and 72 hours
Secondary outcomes (6)
Evaluation of episodic memory
Number of correct hits (CH) at 30-minutes and 72-hours in the Epilepsy group compared to the Control group
Measured: 30 minutes and 72 hours
Qualitative distribution of errors at 30-minutes and 72-hours recalls
Number of false-alarm errors (FA) involving familiar but non associated items (FNAI) and number of FA involving hybrid items (HI) during the 30-minutes and 72-hours recalls in the Epilepsy group compared to the Control group
Measured: 30 minutes and 72 hours
Relationship between the extent of forgetting at 30 minutes and 72 hours and the nature of contextual associations during the acquisition phase
Proportion of FA regarding associations categorized as "not linked" during the encoding phase
Measured: 30 minutes and 72 hours
Relevance of a simple recognition to assess episodic memory at 30 minutes and 72 hours
Number of correct recognitions (CR) during the 30-minutes and 72-hours recalls in the Epilepsy group compared to the Control group
Measured: 30 minutes and 72 hours
Effect of antiepileptic treatment currently taken by the patient (reported through clinical data) on the extent of memory loss assessed at 72 hours
Relation between the number of antiseizure drugs (molecules) currently taken by the patient and available in clinical data and the memory loss (number of correct answers at 30 minutes - number of correct answers at 72 hours)
Measured: 72 hours
Effect of the usual frequency of seizures reported by the patient through a dedicated agenda on the extent of memory loss assessed at 72 hours
Relation between monthly seizures frequency within the 3 months preceding the inclusion and reported through a dedicated agenda and the memory loss (number of correct answers at 30 minutes - number of correct answers at 72 hours).
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start26 Jan 2022
- Primary completion27 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victoria Guinet, PhD student, Principal investigator, Service de Neurologie Fonctionnelle et d'Epileptologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924933
- Sponsor's protocol ID
- 69HCL21_0264
- Other IDs
- 2021-A01075-36
- Acronym
- EPIMNESIE
- Status last verified
- Jan 2025
- First submitted
- 27 May 2021
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Episodic Memory and Accelerated Long-term Forgetting in Patients With Drug-resistant Focal Epilepsy
- ClinicalTrials.gov ID
- NCT04924933
- Acronym / sponsor ID
- EPIMNESIE / 69HCL21_0264
- Conditions
- Epilepsy
- Keywords
- Temporal lobe epilepsy, Episodic memory, Accelerated long-term forgetting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 14 Jun 2021 (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.
Drug-resistant focal epilepsy (DRFE) is frequently associated with complications of varying severity that impair patient's quality of life. Among these complications, cognitive disturbances and especially episodic memory difficulties, play a determinant part. Episodic memory can be defined as a function that allows the mental reconstruction of a past life episode, through complex associative mechanisms that link the vivid experience to its context of occurrence, called encoding context. It is a dynamic cognitive function, which calls on a widely distributed cerebral network, mainly involving the medial temporal lobe, particularly the hippocampus. Epilepsy could have a specific impact on this crucial network, disrupting the binding mechanisms between the experienced events and their encoding context, which are essential for efficient memory. Although patients with DRFE frequently demonstrate memory impairment as assessed by standardised neuropsychological tests, it only imperfectly reflects their difficulties. As a matter of fact, despite a subjective memory complaint, about 20% have no memory impairment on these tests, resulting from a phenomenon called accelerated long-term forgetting (ALF). ALF is indeed characterised by normal performance on standardised neuropsychological tests involving retention delays of 20-30 minutes, but disabling memory complaint and abnormally marked forgetting within hours or days that follow the learning period. This phenomenon is widely described at the conceptual level, but remains difficult to measure in daily practice, at least partly due to methodological limits. Thus, the validated tools available in clinical routine are poorly adapted to the complexity and the associative dimension of memory networks. There is therefore a clinical need for a specific assessment tool that would be able to detect ALF, in order to better quantify it and to enable the appropriate care of patients suffering from DRFE. The aim of the EPIMNESIE study is to evaluate the diagnostic capacity of a behavioural associative memory task, based on the analysis of encoding and consolidation mechanisms, in order to measure ALF. In this prospective study, 40 patients with DRFE and 40 healthy subjects will be proposed to complete a new associative memory task involving a learning phase and two recall sessions which will take place at 30 minutes and 72 hours after the learning phase.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients (Epilepsy group) | Experimental | Diagnostic Test: Computerised associative memory task using abstract words and landscape photographsPatients with drug-resistant focal epilepsy in whom an accelerated long-term forgetting is suspected (presence of a subjective memory complaint and absence of objective deficit in memory tests conducted in the frame of a routine comprehensive neuropsychological assessment) |
| Healthy volunteers (control group) | Active comparator | Diagnostic Test: Computerised associative memory task using abstract words and landscape photographsAge-matched healthy volunteers |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Adult (≥ 18 years old) suffering from drug-resistant focal epilepsy
- Patient who recently benefit from a comprehensive neuropsychological assessment (≤2 years)
- Patient presenting a subjective memory complaint consistent with an ALF
- Patient who obtained normal performance at memory tests during the comprehensive neuropsychological assessment
- Patient who gave its written informed consent to participate to the study
Key exclusion criteria (11 listed)
- Patient with impaired reading or understanding
- Patient suffering from a major depressive syndrome (score >15 on the French version of the Neurological Disorders Depression Inventory for Epilepsy - NDDIE)
- Patient who have undergone epilepsy surgery
- Patient who presented a seizure within the hour preceding the first test session
- Protected major
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 |
|---|---|---|
| Computerised associative memory task using abstract words and landscape photographsTwo test sessions using the computerised associative memory task will be performed by the two groups (patients and control subjects). The first session will consist of the encoding of 56 associations between a word and a photograph and the recall of half of them (28) 30 minutes later by the mean of a matching task and a recognition task. The second session consists of the recall of the other half of the associations (28) 72 hours after the encoding phase, using the same procedure (matching task and recognition task). Performance obtained by patients and by healthy volunteers will then be compared. | Diagnostic test | Healthy volunteers (control group), Patients (Epilepsy group) |
Primary outcome
Evaluation of memory loss
Time frame: 30 minutes and 72 hours
Memory loss 72 hours after the encoding phase compared to the performance obtained at 30 minutes, based on the number of correct hits (CH - calculated on 28 items) obtained at these two moments. The memory loss will be calculated as the difference between the number of CH: CH 30 minutes - CH 72 hours.
6 secondary outcomes
Evaluation of episodic memory
Time frame: 30 minutes and 72 hours
Qualitative distribution of errors at 30-minutes and 72-hours recalls
Time frame: 30 minutes and 72 hours
Relationship between the extent of forgetting at 30 minutes and 72 hours and the nature of contextual associations during the acquisition phase
Time frame: 30 minutes and 72 hours
Relevance of a simple recognition to assess episodic memory at 30 minutes and 72 hours
Time frame: 30 minutes and 72 hours
Effect of antiepileptic treatment currently taken by the patient (reported through clinical data) on the extent of memory loss assessed at 72 hours
Time frame: 72 hours
Effect of the usual frequency of seizures reported by the patient through a dedicated agenda on the extent of memory loss assessed at 72 hours
Time frame: 72 hours
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 4 Jun 2025.
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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.
Victoria Guinet, PhD student principal investigator
Service de Neurologie Fonctionnelle et d'Epileptologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerised associative memory task using abstract words and landscape photographs in people with Epilepsy, run by Hospices Civils de Lyon 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 11 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 4 Jun 2025. 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?
Evaluation of memory loss (time frame: 30 minutes and 72 hours). 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 4 Jun 2025.