NCT03865771 Sleep Related Memory Consolidation in Children With Age Related Focal Epilepsy.
| NCT ID | NCT03865771 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Strasbourg, France |
| Condition | Benign Epilepsy With Centro Temporal Spikes (BECTS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 95 participants |
| Start Date | 2019-03-27 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 95 participants in total. It began in 2019-03-27 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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
Eligibility Criteria
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
Contact & Investigator
Anne DE SAINT MARTIN, MD
PRINCIPAL INVESTIGATOR
Hôpitaux Universitaires de Strasbourg
Frequently Asked Questions
Who can join the NCT03865771 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 13 Years, studying Benign Epilepsy With Centro Temporal Spikes (BECTS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03865771 currently recruiting?
Yes, NCT03865771 is actively recruiting participants. Contact the research team at anne.desaintmartin@chru-strasbourg.fr for enrollment information.
Where is the NCT03865771 trial being conducted?
This trial is being conducted at Nancy, France, Strasbourg, France.
Who is sponsoring the NCT03865771 clinical trial?
NCT03865771 is sponsored by University Hospital, Strasbourg, France. The principal investigator is Anne DE SAINT MARTIN, MD at Hôpitaux Universitaires de Strasbourg. The trial plans to enroll 95 participants.
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