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

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ClinicalTrials.gov Identifier: NCT03865771
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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

Condition or disease Intervention/treatment Phase
Benign Epilepsy With Centro Temporal Spikes (BECTS) Atypical Benign Partial Epilepsy (ABPE) Epileptic Encephalopathy With Continuous Spike and Waves During Sleep (ECSWS) Behavioral: Neuropsychological testing Behavioral: Neuropsychological procedure Other: Video EEG and polysomnography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Sleep Related Memory Consolidation in Children With Age Related Focal Epilepsy.
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020


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)

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




Primary Outcome Measures :
  1. 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 Measures :
  1. memory lapse rate for each group [ Time Frame: at 1 hour, 5 hours, 24 hours ]
  2. Correlation of memory lapse rate with Executive functioning tests scores [ Time Frame: at 1 hour, 5 hours, 24 hours ]
  3. Correlation of memory lapse rate with age of onset, epilepsy phase, treatment [ Time Frame: at 1 hour, 5 hours, 24 hours ]
  4. 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 ]
  5. Correlation of memory lapse rate with number and organization of sleep cycles [ Time Frame: at 1 hour, 5 hours, 24 hours ]


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Ages Eligible for Study:   6 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865771


Contacts
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Contact: Anne DE SAINT MARTIN, MD + 33 3.88.12.83.98 anne.desaintmartin@chru-strasbourg.fr
Contact: Lucille SCHNEIDER lucille.schneider@chru-strasbourg.fr

Locations
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France
Hopital D'Enfants Pediatrie Medicale Ambulatoire Not yet recruiting
Nancy, France, 54511
Contact: Emmanuel RAFFO, MD PhD       e.raffo@chru-nancy.fr   
Principal Investigator: Emmanuel RAFFO         
Sub-Investigator: Dominique STESCHENKO         
Hopital de Hautepierre-Service de Pediatrie/Neurologie Recruiting
Strasbourg, France, 67098
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         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Anne DE SAINT MARTIN, MD Hôpitaux Universitaires de Strasbourg

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03865771     History of Changes
Other Study ID Numbers: 6995
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Strasbourg, France:
Memory consolidation
Epilepsy
Childhood
Benign epilepsy with centro temporal spikes (BECTS)
Epileptic encephalopathy with continuous spike and waves during sleep (ECSWS)

Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Epilepsies, Partial
Epilepsy, Rolandic
Central Nervous System Diseases
Nervous System Diseases
Epileptic Syndromes