Sleep Related Memory Consolidation in Children With Age Related Focal Epilepsy. (EPIMEM)

June 16, 2023 updated by: University Hospital, Strasbourg, France

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Nancy, France, 54511
        • Recruiting
        • Hopital D'Enfants Pediatrie Medicale Ambulatoire
        • Contact:
        • Principal Investigator:
          • Calina TODOSI
        • Sub-Investigator:
          • Mathieu KUCHENBUCH
        • Sub-Investigator:
          • Pauline DENIAU
        • Sub-Investigator:
          • Clémentine LAMBERT
        • Sub-Investigator:
          • Hélène VINCENT
      • Strasbourg, France, 67098
        • Recruiting
        • Hopital de Hautepierre-Service de Pediatrie/Neurologie
        • Contact:
          • Anne DE SAINT MARTIN, MD
        • Sub-Investigator:
          • Vincent LAUGEL
        • Sub-Investigator:
          • Marie Aude SPITZ
        • Sub-Investigator:
          • Marie-Thérèse ABI WARDE
        • Sub-Investigator:
          • Edouard HIRSCH
        • Sub-Investigator:
          • Paola VALENTI HIRSCH
        • Sub-Investigator:
          • Clotilde BOULAY
        • Principal Investigator:
          • Anne DE SAINT MARTIN
        • Sub-Investigator:
          • Sarah BAER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 13 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EPILEPSY GROUP

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
Behavioral: Neuropsychological testing
memory, executive testing, behaviour questionnaire, visual attention,
Behavioral: Neuropsychological procedure
Rey auditory verbal learning test, Delayed recall : 1h, 5h, 24h (after one night sleep)
Other: CONTROL GROUP

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
Behavioral: Neuropsychological testing
memory, executive testing, behaviour questionnaire, visual attention,
Behavioral: Neuropsychological procedure
Rey auditory verbal learning test, Delayed recall : 1h, 5h, 24h (after one night sleep)
Other: Video EEG and polysomnography
Video EEG : 10 electrodes + 3 electrodes for PSG 2h wake EEG Whole night EEG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
memory lapse rate for each group
Time Frame: at 1 hour, 5 hours, 24 hours
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
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
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
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
at 1 hour, 5 hours, 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Anne DE SAINT MARTIN, MD, Hopitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2019

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

March 4, 2019

First Posted (Actual)

March 7, 2019

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6995

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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