跳至主要内容
临床试验/NCT04253379
NCT04253379招募中不适用

Impact of Executive Functions and Language on Social Cognition in Pediatric Epilepsy

CHU de Reims2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2020年2月2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
CHU de Reims
入组人数
96
试验地点
2
主要终点
Social cognition evaluation

研究概览

简要总结

The purpose of this study is to investigate the development of social cognition skills in pediatric epilepsy compared to healthy children. There are evidences indicating that children with epilepsy have executive dysfunctions and language problems. Executive functions refer to multiple cognitive processes that contribute to human higher order abilities, such as purposeful and future-orientated behavior. Moreover, the literature regarding development of non epileptic children, with ordinary development indicates that executive functions and language are linked to the emergence of social cognition. Then, the investigators asked if children with epilepsy, as they commonly present executive dysfunctions, would show an atypical development of social cognition. Children with epilepsy and a control group of healthy volunteers will be compared to identify relationships between executive functions, language and social cognition.

详细描述

Epilepsy is a chronic disorder which affects 50 million people all over the world, with a childhood-onset in 75% of cases. This disorder may interfere with the normal cerebral development and impact cognition skills (Bouis, Cavézian et Chokron, 2011 ; Gallagher et Lassonde, 2005). Executive and language functions are often shown to be affected in previous studies with children with epilepsy (Gencpinar et al., 2015 ; Verrotti, Matricardi, Rinaldi, Prezioso et Coppola, 2015). However, executive functioning and language development are known to be implicated in social cognition acquisitions (Carlson et Moses, 2001 ; Smogorzewska, Szumski et Grygiel, 2018). Yet, less is known about social cognition development in people with epilepsy. Social cognition generally refers to mental operations that underlie social interactions, including perceiving, interpreting, managing, and generating responses to socially relevant stimuli, including the intentions and behaviors others.

The purpose of this protocol is to compare development of social cognition skills, language and executive functions in children with and without epilepsy. This is an observational study; volunteers who participate will not receive any new or experimental therapies. Children in this protocol will undergo an evaluation which may include: a medical history including characteristics of their epilepsy (age at onset, number of antiepileptic drugs, seizure frequency, …) , a nonverbal intellectual efficiency measure , an evaluation of theory of mind, key concept of social cognition, and executive functions then an evaluation of verbal skills .The second purpose of this protocol is to permit the identification of links between development of social cognition and executive et language functions.

Children with epilepsy experience more learning disabilities and behavioral disorders. The treatment of pediatric epilepsy concerns seizure reduction but also reeducation therapy to improve scholar outcome, like speech therapy of psychomotricity. Social consequences may be underestimated in this population, including social cognition.

研究设计

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

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • exposed children : children aged 6-12 with a diagnosis of epilepsy French native speaker
  • A control group of age-matched children who meet patient selection criteria with the exception of the epilepsy will also be sought

排除标准

  • neurological or psychiatric disease in control group
  • Raven's Matrices score < percentile 10

结局指标

主要结局

Social cognition evaluation

时间窗: Day 0

The cognitive theory of mind test The Cognitive Theory of mind will be evaluated with questions about 4 small stories of false beliefs. Number of items : 8 questions Minimum and Maximum values : 0-8 correct responses

次要结局

  • Executive functions evaluation(Day 0)
  • language evaluation(Day 0)
  • Non verbal intellectual efficiency(Day 0)

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验