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临床试验/NCT03251820
NCT03251820Unknown不适用

Management Strategies for Electrical Status Epilepticus During Sleep

Randa Abdelbadie Abdelaleem0 个研究点目标入组 50 人开始时间: 2018年2月最近更新:
适应症
相关药物

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
Cognitive ability

研究概览

简要总结

Electrical status epilepticus during slow wave sleep is a condition in which the epileptic patient starts to develop neurocognitive deterioration, any type of seizures and continuous electrical activity in the EEG during non rapid eye movement sleep. It is an age related condition and will resolve spontaneously at around the age of puberty. However if left untreated or treatment is delayed, it may lead to permanent neurocognitive deterioration. Thus early diagnosis and treatment is essential in these children to preserve neurocognitive function.

详细描述

Electrical status epilepticus in sleep (ESES), also known as continuous spikes and waves during slow sleep (CSWS), is an age related, self - limiting disorder characterized by:

  1. epilepsy with different seizure types,
  2. neuropsychological regression, and
  3. typical EEG pattern of continuous epileptiform activity during non-rapid eye movement sleep (NREM).

During wakefulness, the EEG shows focal/multifocal spikes that increase in frequency during the acute stage. During sleep, ESES appears and is characterized by (1) marked potentiation of epileptiform discharges during non-REM sleep, leading to (2) a (near)-continuous, bilateral, or occasionally lateralized slow spikes and waves, (3) and these spikes and waves occur "during a significant proportion" of the non-REM sleep with a threshold ranging from 25% to 85%

The exact incidence of CSWS is not known. In pediatric neurology clinics, a reported frequency of 0.2% of childhood epilepsies most probably underestimates the incidence of CSWS.

CSWS is a devastating syndrome, which requires prompt treatment, the efficacy of which is checked with regular intervals, e.g. three or six months. Although epilepsy resolves with time in most cases, many children are left with significant cognitive or language impairment. Longer duration of ESES appears to be the major predictor of poor outcome.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All epileptic patients above 2 years of age presenting with neuropsychological deterioration, seizures and ESES in NREM sleep. The degree of epileptic activity during sleep will be measured and expressed as a spike wave index (SWI), which is defined as the total duration of continuous epileptic activity relative to total slow sleep duration. SWI must be at least 25% or more.

排除标准

  • Any epileptic patient not presenting with typical EEG findings and neurocognitive regression.

结局指标

主要结局

Cognitive ability

时间窗: IQ measured before treatment and after completing treatment course and then every three months for one year

Change in cognitive ability in response to steroids and benzodiazepines by IQ assessment using using Standford - Binnet scales version V.

Interictal epileptiform activity

时间窗: EEG will be done every three months for upto one year after discontinuation of therapy

epileptiform activity will be assessed by EEG recordings during sleep. The degree of epileptic activity during sleep will be measured and expressed as a spike wave index (SWI), which is defined as the total duration of continuous epileptic activity relative to total slow sleep duration.

次要结局

  • Change in seizure frequency(Measured before and one year after treatment)

研究者

发起方
Randa Abdelbadie Abdelaleem
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Randa Abdelbadie Abdelaleem

Assistant lecturer

Assiut University

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