Atypical Benign Partial Epilepsy (ABPE) Clinical Trial
— EPIMEMOfficial title:
Sleep Related Memory Consolidation in Children With Age Related Focal Epilepsy.
| NCT number | NCT03865771 |
| Other study ID # | 6995 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 27, 2019 |
| Est. completion date | September 2024 |
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
| Status | Recruiting |
| Enrollment | 95 |
| Est. completion date | September 2024 |
| Est. primary completion date | September 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years to 13 Years |
| Eligibility | Inclusion Criteria: 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: - 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 Exclusion Criteria: 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 - mental deficiency Control group - neurologic trouble - abnormal sleep EEG - intellectual deficiency |
| Country | Name | City | State |
|---|---|---|---|
| France | Hopital D'Enfants Pediatrie Medicale Ambulatoire | Nancy | |
| France | Hopital de Hautepierre-Service de Pediatrie/Neurologie | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 24 hours | ||
| Secondary | memory lapse rate for each group | at 1 hour, 5 hours, 24 hours | ||
| Secondary | Correlation of memory lapse rate with Executive functioning tests scores | at 1 hour, 5 hours, 24 hours | ||
| Secondary | Correlation of memory lapse rate with age of onset, epilepsy phase, treatment | at 1 hour, 5 hours, 24 hours | ||
| Secondary | Correlation of memory lapse rate with EEG severity scale, atypical criteria, EEG focus localization, sleep discharges frequency | at 1 hour, 5 hours, 24 hours | ||
| Secondary | Correlation of memory lapse rate with number and organization of sleep cycles | at 1 hour, 5 hours, 24 hours |