跳至主要内容
临床试验/NCT03865771
NCT03865771招募中不适用

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

University Hospital, Strasbourg, France4 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2019年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
95
试验地点
4
主要终点
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

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
6 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • normal psychomotor development
  • informed consent signed by both parents and subject if able
  • affiliated to social security regimen
  • 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

排除标准

  • Psychiatric trouble (DSM V) Sensorial trouble without correction Poor command of French language Minor under care
  • Patients from "severe" and "benign" groups:
  • degenerative disease
  • abnormal neuroimaging
  • mental deficiency
  • Control group
  • neurologic trouble
  • abnormal sleep EEG
  • intellectual deficiency

结局指标

主要结局

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

时间窗: 24 hours

次要结局

  • Correlation of memory lapse rate with EEG severity scale, atypical criteria, EEG focus localization, sleep discharges frequency(at 1 hour, 5 hours, 24 hours)
  • Correlation of memory lapse rate with Executive functioning tests scores(at 1 hour, 5 hours, 24 hours)
  • Correlation of memory lapse rate with age of onset, epilepsy phase, treatment(at 1 hour, 5 hours, 24 hours)
  • memory lapse rate for each group(at 1 hour, 5 hours, 24 hours)
  • Correlation of memory lapse rate with number and organization of sleep cycles(at 1 hour, 5 hours, 24 hours)

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (4)

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