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

Primary Purpose

Benign Epilepsy With Centro Temporal Spikes (BECTS), Atypical Benign Partial Epilepsy (ABPE), Epileptic Encephalopathy With Continuous Spike and Waves During Sleep (ECSWS)

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuropsychological testing
Neuropsychological procedure
Video EEG and polysomnography
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Benign Epilepsy With Centro Temporal Spikes (BECTS) focused on measuring Memory consolidation, Epilepsy, Childhood, Benign epilepsy with centro temporal spikes (BECTS), Epileptic encephalopathy with continuous spike and waves during sleep (ECSWS)

Eligibility Criteria

6 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital D'Enfants Pediatrie Medicale AmbulatoireRecruiting
  • Hopital de Hautepierre-Service de Pediatrie/NeurologieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

EPILEPSY GROUP

CONTROL GROUP

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

memory lapse rate for each group
Correlation of memory lapse rate with Executive functioning tests scores
Correlation of memory lapse rate with age of onset, epilepsy phase, treatment
Correlation of memory lapse rate with EEG severity scale, atypical criteria, EEG focus localization, sleep discharges frequency
Correlation of memory lapse rate with number and organization of sleep cycles

Full Information

First Posted
March 4, 2019
Last Updated
June 16, 2023
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT03865771
Brief Title
Sleep Related Memory Consolidation in Children With Age Related Focal Epilepsy.
Acronym
EPIMEM
Official Title
Sleep Related Memory Consolidation in Children With Age Related Focal Epilepsy.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2019 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
95 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EPILEPSY GROUP
Arm Type
Experimental
Arm Description
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
Arm Title
CONTROL GROUP
Arm Type
Other
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological testing
Intervention Description
memory, executive testing, behaviour questionnaire, visual attention,
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological procedure
Intervention Description
Rey auditory verbal learning test, Delayed recall : 1h, 5h, 24h (after one night sleep)
Intervention Type
Other
Intervention Name(s)
Video EEG and polysomnography
Intervention Description
Video EEG : 10 electrodes + 3 electrodes for PSG 2h wake EEG Whole night EEG
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
memory lapse rate for each group
Time Frame
at 1 hour, 5 hours, 24 hours
Title
Correlation of memory lapse rate with Executive functioning tests scores
Time Frame
at 1 hour, 5 hours, 24 hours
Title
Correlation of memory lapse rate with age of onset, epilepsy phase, treatment
Time Frame
at 1 hour, 5 hours, 24 hours
Title
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
Title
Correlation of memory lapse rate with number and organization of sleep cycles
Time Frame
at 1 hour, 5 hours, 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne DE SAINT MARTIN, MD
Phone
+ 33 3.88.12.83.98
Email
anne.desaintmartin@chru-strasbourg.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Lucille SCHNEIDER
Email
lucille.schneider@chru-strasbourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne DE SAINT MARTIN, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital D'Enfants Pediatrie Medicale Ambulatoire
City
Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Calina TODOSI, MD
Email
c.todosi@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
Calina TODOSI
First Name & Middle Initial & Last Name & Degree
Mathieu KUCHENBUCH
First Name & Middle Initial & Last Name & Degree
Pauline DENIAU
First Name & Middle Initial & Last Name & Degree
Clémentine LAMBERT
First Name & Middle Initial & Last Name & Degree
Hélène VINCENT
Facility Name
Hopital de Hautepierre-Service de Pediatrie/Neurologie
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne DE SAINT MARTIN, MD
First Name & Middle Initial & Last Name & Degree
Vincent LAUGEL
First Name & Middle Initial & Last Name & Degree
Marie Aude SPITZ
First Name & Middle Initial & Last Name & Degree
Marie-Thérèse ABI WARDE
First Name & Middle Initial & Last Name & Degree
Edouard HIRSCH
First Name & Middle Initial & Last Name & Degree
Paola VALENTI HIRSCH
First Name & Middle Initial & Last Name & Degree
Clotilde BOULAY
First Name & Middle Initial & Last Name & Degree
Anne DE SAINT MARTIN
First Name & Middle Initial & Last Name & Degree
Sarah BAER

12. IPD Sharing Statement

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Sleep Related Memory Consolidation in Children With Age Related Focal Epilepsy.

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