Clinical trial NCT03865771: Sleep Related Memory Consolidation in Children With Age Related Focal Epilepsy.
Official title: Sleep Related Memory Consolidation in Children With Age Related Focal Epilepsy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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)
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 95
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Primary outcomes:
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
timeFrame: 24 hours
Secondary outcomes:
measure: memory lapse rate for each group
timeFrame: at 1 hour, 5 hours, 24 hours
measure: Correlation of memory lapse rate with Executive functioning tests scores
timeFrame: at 1 hour, 5 hours, 24 hours
measure: Correlation of memory lapse rate with age of onset, epilepsy phase, treatment
timeFrame: at 1 hour, 5 hours, 24 hours
measure: Correlation of memory lapse rate with EEG severity scale, atypical criteria, EEG focus localization, sleep discharges frequency
timeFrame: at 1 hour, 5 hours, 24 hours
measure: Correlation of memory lapse rate with number and organization of sleep cycles
timeFrame: at 1 hour, 5 hours, 24 hours
Other outcomes:
Locations:
city: Nancy
country: France
facility: Hopital D'Enfants Pediatrie Medicale Ambulatoire
city: Strasbourg
country: France
facility: Hopital de Hautepierre-Service de Pediatrie/Neurologie
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Anne DE SAINT MARTIN, MD
role: PRINCIPAL_INVESTIGATOR
References: