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临床试验/NCT05487521
NCT05487521已完成3 期

Evaluation of Sleep EEG Changes in Paediatric Patients With Language Dysfunction: A Follow up Study. Evaluation of Sleep EEG Changes in Paediatric Patients With Language Dysfunction: A Follow up Study. Evaluation of Sleep EEG Changes in Pediatric Patients With Language Dysfunction : A Follow up Study

Ain Shams University1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2020年2月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
93
试验地点
1
主要终点
language age of the patient

研究概览

简要总结

In general, the severity of the patients' language disorders fluctuated with the degree of EEG epileptiform activity . Since then, a spectrum of disorders, often referred to collectively as the epilepsy-aphasia spectrum, have been described that share features of sleep potentiated EEG abnormalities, cognitive problems, and rare or even absent clinical seizures .

In our study , Investigators evaluated the sleep EEG changes in pediatrics with languague dysfunction then in patients with EEG changes , investigators gave treatment according to type of EEG changes and investigators did a follow up assessment of language , EEG changes and frequency of clinical seizures if present at first .

详细描述

Language dysfunction is one of the most common problems in paediatrics. There is increased interest in association of epilepsy and epileptiform EEG abnormalities to language dysfunction.

Electrographic status epilepticus in sleep or continuous spike - wave in slow wave during sleep, is a typical feature of acquired epileptic aphasia feature in sleep, or continuous spike-wave in slow-wave sleep, is a typical.

Our study screened for sleep potentiated epileptiform discharges in children with language dysfunction and effect of treatment of these epileptiform discharges on language dysfunction improvement.

The aim of our work :

  • The primary aim of this work was to screen for sleep potentiated epileptiform discharges in children with language dysfunction.
  • To evaluate effect of treatment of these epileptiform discharges on Language dysfunction improvement .

研究设计

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

入排标准

年龄范围
3 Years 至 10 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •o Language delay (their language age is below their chronological age ),or Language regression (any convincing report of loss of previously acquired language skills, whether or not prior language development was reported as normal or delayed) (Meilleur et al., 2009)
  • •Age from 3 to 10 years old.

排除标准

  • •o Patients with hearing problems.
  • •Patients whose language delay can be explained by organic disease (e.g. post Hypoxic ischemic encephalopathy, known inborn error of metabolism - whether this language delay is isolated or occurring in the context of global developmental delay).
  • •Patients with mental delay.
  • •Patients with autism spectrum disorder ( according to DSM-5 standardized criteria, 2013)
  • •Enviromentally deprived patients.

研究组 & 干预措施

Patients with EEG changes or clinical seizures

Experimental

干预措施: Methylprednisolone and or prednisolone (Drug)

结局指标

主要结局

language age of the patient

时间窗: 6 months

we follow up language age of the patient after treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omnia Alaa Mahsoub Abdelsalam

Principal investigator

Ain Shams University

研究点 (1)

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