Benign Epilepsy With Centro Temporal Spikes (BECTS)EPIMEMNCT03865771
Sleep Related Memory Consolidation in Children With Age Related Focal Epilepsy.
A study testing Neuropsychological testing, Neuropsychological procedure and Video EEG and polysomnography in people with Benign Epilepsy With Centro Temporal Spikes (BECTS) and Atypical Benign Partial Epilepsy (ABPE), run by University Hospital, Strasbourg, France at 2 sites in France.
Trial summary
Age related focal epilepsies in children encompasses, according to the ILAE criteria, benign epilepsy with centro temporal spikes (BECTS), atypical benign partial epilepsy (ABPE) and epileptic encephalopathy with continuous spike and waves during sleep (ECSWS). Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Benign Epilepsy With Centro Temporal Spikes (BECTS), Atypical Benign Partial Epilepsy (ABPE), Epileptic Encephalopathy With Continuous Spike and Waves During Sleep (ECSWS)
- What is being tested?
- Neuropsychological testing, Neuropsychological procedure and Video EEG and polysomnography
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Mar 2019to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Principal:
- normal psychomotor development
- informed consent signed by both parents and subject if able
- affiliated to social security regimen
- Specific
- Patients from "severe" and "benign" groups:
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- focal age related epilepsy: BECTS, ABPE, ECSWS (ILAE criteria)
- children hospitalized for their follow-up
- normal neuroimaging
- Control group
- -children hospitalized for a non neurologic disease
Who cannot join
- Principal:
- Psychiatric trouble (DSM V) Sensorial trouble without correction Poor command of French language Minor under care
- Specific
- Patients from "severe" and "benign" groups:
- degenerative disease
- abnormal neuroimaging
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- mental deficiency
- Control group
- neurologic trouble
- abnormal sleep EEG
- intellectual deficiency
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lucille SCHNEIDER contact
France2 sites, 2 recruiting
- Recruiting
Hopital D'Enfants Pediatrie Medicale Ambulatoire
Nancy, 54511
Mathieu KUCHENBUCH, MD, m.kuchenbuch@chru-nancy.fr
Calina TODOSI
- Recruiting
Hopital de Hautepierre-Service de Pediatrie/Neurologie
Strasbourg, 67098
Anne DE SAINT MARTIN, MD
Vincent LAUGEL
About this study
Age related focal epilepsies in children encompasses, according to the ILAE criteria, benign epilepsy with centro temporal spikes (BECTS), atypical benign partial epilepsy (ABPE) and epileptic encephalopathy with continuous spike and waves during sleep (ECSWS). These non structural epilepsies are associated with interictal sleep spike and waves activated by sleep. Moreover, high prevalence of learning disorders occur in children with age related epilepsies. A correlation is suspected between learning disorders and sleep activation of spike and waves. The investigators suppose that learning dysfunction is linked to loss of information during sleep of epileptic children, unlike for control patients. As sleep allows memory consolidation of words learned during wakefulness, an epileptic activity during sleep may disrupt this consolidation, leading to a loss of information.
Hypothesis: the investigators hypothesize a disruption of memory consolidation after one night in children affected with ABPE and ECSWS (severe group) compared to memory consolidation in children affected with BECTS (benign group), and control group.
Read more
Primary purpose:
To demonstrate that the deficit of delayed recall in 15 word learning test after one night is higher for the "severe group", compared to the "benign group" and the control group.
Secondary purposes:
- to study the evolution over time of memory consolidation
- to evaluate the correlation of the deficit of delayed recall with executive dysfunction, clinical factors of epilepsy, neurophysiological factors of epilepsy, and sleep architecture
- Conditions
- Benign Epilepsy With Centro Temporal Spikes (BECTS), Atypical Benign Partial Epilepsy (ABPE), Epileptic Encephalopathy With Continuous Spike and Waves During Sleep (ECSWS)
- Being tested
- Neuropsychological testing, Neuropsychological procedure, Video EEG and polysomnography
- Keywords
- Memory consolidation, Epilepsy, Childhood, Benign epilepsy with centro temporal spikes (BECTS), Epileptic encephalopathy with continuous spike and waves during sleep (ECSWS)
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testingBehavioural
memory, executive testing, behaviour questionnaire, visual attention,
Neuropsychological procedureBehavioural
Rey auditory verbal learning test, Delayed recall : 1h, 5h, 24h (after one night sleep)
Video EEG and polysomnographyOther
Video EEG : 10 electrodes + 3 electrodes for PSG 2h wake EEG Whole night EEG
| Study group | Role | What they receive |
|---|---|---|
| EPILEPSY GROUP | Experimental | Patients with typical BECTS (benign group) or atypical BECTS or ECSWS (severe group)
Medical visit
Neuropsychological testing
Neuropsychological procedure
Video EEG and polysomnography (standard of care procedure): 2h wake and whole night
Sleep diary Receives: Behavioral: Neuropsychological testing; Behavioral: Neuropsychological procedure |
| CONTROL GROUP | Other | Patients hospitalized for non neurologic illness (diabetes, nephropathy, chronic intestinal disease)
Medical visit
Neuropsychological testing
Neuropsychological procedure
Video EEG and polysomnography : 2h wake and whole night
Sleep diary Receives: Behavioral: Neuropsychological testing; Behavioral: Neuropsychological procedure; Other: Video EEG and polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
memory lapse rate at 24 hours in the severe group, the benign group and the control group. ("memory lapse rate": rate of non recalled words number, during the delayed recall phase of the test, related to the maximal number of words recalled
Measured: 24 hours
Secondary outcomes (5)
memory lapse rate for each group
Measured: at 1 hour, 5 hours, 24 hours
Correlation of memory lapse rate with Executive functioning tests scores
Measured: at 1 hour, 5 hours, 24 hours
Correlation of memory lapse rate with age of onset, epilepsy phase, treatment
Measured: at 1 hour, 5 hours, 24 hours
Correlation of memory lapse rate with EEG severity scale, atypical criteria, EEG focus localization, sleep discharges frequency
Measured: at 1 hour, 5 hours, 24 hours
Correlation of memory lapse rate with number and organization of sleep cycles
Measured: at 1 hour, 5 hours, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start27 Mar 2019
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Epilepsy With Centro Temporal Spikes (BECTS)Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne DE SAINT MARTIN, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865771
- Sponsor's protocol ID
- 6995
- Acronym
- EPIMEM
- Status last verified
- Nov 2025
- First submitted
- 4 Mar 2019
- Last updated
- 5 Dec 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 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Related Memory Consolidation in Children With Age Related Focal Epilepsy.
- ClinicalTrials.gov ID
- NCT03865771
- Acronym / sponsor ID
- EPIMEM / 6995
- Conditions
- Benign Epilepsy With Centro Temporal Spikes (BECTS), Atypical Benign Partial Epilepsy (ABPE), Epileptic Encephalopathy With Continuous Spike and Waves During Sleep (ECSWS)
- Keywords
- Memory consolidation, Epilepsy, Childhood, Benign epilepsy with centro temporal spikes (BECTS), Epileptic encephalopathy with continuous spike and waves during sleep (ECSWS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 7 Mar 2019 (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.
Age related focal epilepsies in children encompasses, according to the ILAE criteria, benign epilepsy with centro temporal spikes (BECTS), atypical benign partial epilepsy (ABPE) and epileptic encephalopathy with continuous spike and waves during sleep (ECSWS). These non structural epilepsies are associated with interictal sleep spike and waves activated by sleep. Moreover, high prevalence of learning disorders occur in children with age related epilepsies. A correlation is suspected between learning disorders and sleep activation of spike and waves. The investigators suppose that learning dysfunction is linked to loss of information during sleep of epileptic children, unlike for control patients. As sleep allows memory consolidation of words learned during wakefulness, an epileptic activity during sleep may disrupt this consolidation, leading to a loss of information.
Hypothesis: the investigators hypothesize a disruption of memory consolidation after one night in children affected with ABPE and ECSWS (severe group) compared to memory consolidation in children affected with BECTS (benign group), and control group.
Primary purpose:
To demonstrate that the deficit of delayed recall in 15 word learning test after one night is higher for the "severe group", compared to the "benign group" and the control group.
Secondary purposes:
- to study the evolution over time of memory consolidation
- to evaluate the correlation of the deficit of delayed recall with executive dysfunction, clinical factors of epilepsy, neurophysiological factors of epilepsy, and sleep architecture
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPILEPSY GROUP | Experimental | Behavioral: Neuropsychological testing, Behavioral: Neuropsychological procedurePatients with typical BECTS (benign group) or atypical BECTS or ECSWS (severe group) Medical visit Neuropsychological testing Neuropsychological procedure Video EEG and polysomnography (standard of care procedure): 2h wake and whole night Sleep diary |
| CONTROL GROUP | Other | Behavioral: Neuropsychological testing, Behavioral: Neuropsychological procedure, Other: Video EEG and polysomnographyPatients hospitalized for non neurologic illness (diabetes, nephropathy, chronic intestinal disease) Medical visit Neuropsychological testing Neuropsychological procedure Video EEG and polysomnography : 2h wake and whole night Sleep diary |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- normal psychomotor development
- informed consent signed by both parents and subject if able
- affiliated to social security regimen
- Specific
- focal age related epilepsy: BECTS, ABPE, ECSWS (ILAE criteria)
Key exclusion criteria (11 listed)
- Psychiatric trouble (DSM V) Sensorial trouble without correction Poor command of French language Minor under care
- Specific
- degenerative disease
- abnormal neuroimaging
- mental deficiency
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 |
|---|---|---|
| Neuropsychological testingmemory, executive testing, behaviour questionnaire, visual attention, | Behavioural | CONTROL GROUP, EPILEPSY GROUP |
| Neuropsychological procedureRey auditory verbal learning test, Delayed recall : 1h, 5h, 24h (after one night sleep) | Behavioural | CONTROL GROUP, EPILEPSY GROUP |
| Video EEG and polysomnographyVideo EEG : 10 electrodes + 3 electrodes for PSG 2h wake EEG Whole night EEG | Other | CONTROL GROUP |
Primary outcome
memory lapse rate at 24 hours in the severe group, the benign group and the control group. ("memory lapse rate": rate of non recalled words number, during the delayed recall phase of the test, related to the maximal number of words recalled
Time frame: 24 hours
5 secondary outcomes
memory lapse rate for each group
Time frame: at 1 hour, 5 hours, 24 hours
Correlation of memory lapse rate with Executive functioning tests scores
Time frame: at 1 hour, 5 hours, 24 hours
Correlation of memory lapse rate with age of onset, epilepsy phase, treatment
Time frame: at 1 hour, 5 hours, 24 hours
Correlation of memory lapse rate with EEG severity scale, atypical criteria, EEG focus localization, sleep discharges frequency
Time frame: at 1 hour, 5 hours, 24 hours
Correlation of memory lapse rate with number and organization of sleep cycles
Time frame: at 1 hour, 5 hours, 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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.
Lucille SCHNEIDER contact
Anne DE SAINT MARTIN, MD principal investigator
Hôpitaux Universitaires de Strasbourg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological testing, Neuropsychological procedure and Video EEG and polysomnography in people with Benign Epilepsy With Centro Temporal Spikes (BECTS) and Atypical Benign Partial Epilepsy (ABPE), run by University Hospital, Strasbourg, France at 2 sites 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: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne DE SAINT MARTIN, MD (+ 33 3.88.12.83.98, anne.desaintmartin@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
memory lapse rate at 24 hours in the severe group, the benign group and the control group. ("memory lapse rate": rate of non recalled words number, during the delayed recall phase of the test, related to the maximal number of words recalled (time frame: 24 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 5 Dec 2025.