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临床试验/NCT04844853
NCT04844853Unknown不适用

High Resolution Electroencephalography Exploration of Tactile Prediction Development

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Tactile prediction at 6

研究概览

简要总结

This project aims to measure repetition suppression and tactile prediction using high-resolution electroencephalography in preschoolers, in order to describe the responses as a function of age, gestational age of birth and the presence of a neurodevelopmental disorder. We will include 100 children aged 2 or 6 years: 25 2-year-olds born prematurely, 25 2-year-olds born at term, 25 6-year-olds with typical development and 25 6-year-olds with neurodevelopmental disorders. We will perform several behavioral evaluations to analyze the results in view of the quality of development.

详细描述

We will include 100 children aged 2 or 6 years: 25 2-year-olds born prematurely, 25 2-year-olds born at term, 25 6-year-olds with typical development and 25 6-year-olds with neurodevelopmental disorders. Children will be recruited from local schools and institutions. Birth will be considered premature if children were born before 36 weeks of gestational age. Children will be considered as having neurodevelopmental disorder if they receive medical and/or paramedical care at the time of measurement for neurodevelopmental disorder, including autism spectrum disorder, attention deficit with or without hyperactivity, tics, learning disorders, but all participants must be attending school at the time of measurement.

Children will come to the lab for a 2 hours session with their parents, during which they will undergo movement, attention and executive functions evaluations. Parents will fill out questionnaires evaluating their child's executive functioning and sensory profile in home/everyday settings. Children will then be equipped with 128-channels electroencephalography and proposed two tests : a modified attention network task and a tactile prediction task.

We will calculate correlations between evoked potential amplitudes during the tactile prediction trials and inhibitory conflict trials. Results will be analysed in the light of age, gestational age at birth, ecological and psychometric evaluations, and neurodevelopmental status.

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
2 Years 至 6 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Age 24 to 35 or 72 to 83 months
  • •Born prematurely or term, with or without neurodevelopmental disorders (see arms)
  • •Parental informed consent
  • •Attending school

排除标准

  • •Severe IQ deficit or language impairment
  • •Psychotropic medication

研究组 & 干预措施

Typical 6

Experimental

6-year-olds with typical developement

干预措施: Laby 5-12 (Behavioral)

Typical 6

Experimental

6-year-olds with typical developement

干预措施: M-ABC 2 (Behavioral)

Preterm 2

Experimental

2-year-olds born prematurely

干预措施: electroencephalography (Device)

Preterm 2

Experimental

2-year-olds born prematurely

干预措施: Tactile stimulation (Device)

Term 2

Experimental

2-year-olds born at term

干预措施: electroencephalography (Device)

Term 2

Experimental

2-year-olds born at term

干预措施: Tactile stimulation (Device)

Typical 6

Experimental

6-year-olds with typical developement

干预措施: electroencephalography (Device)

Typical 6

Experimental

6-year-olds with typical developement

干预措施: Tactile stimulation (Device)

Typical 6

Experimental

6-year-olds with typical developement

干预措施: Attention Network task (computerized) (Behavioral)

Typical 6

Experimental

6-year-olds with typical developement

干预措施: Head-toes-knees-schoulders (Behavioral)

Typical 6

Experimental

6-year-olds with typical developement

干预措施: Stroop animals (Behavioral)

NDD 6

Experimental

6-year-olds with neurodevelopmental disorders

干预措施: electroencephalography (Device)

NDD 6

Experimental

6-year-olds with neurodevelopmental disorders

干预措施: Tactile stimulation (Device)

NDD 6

Experimental

6-year-olds with neurodevelopmental disorders

干预措施: Attention Network task (computerized) (Behavioral)

NDD 6

Experimental

6-year-olds with neurodevelopmental disorders

干预措施: Head-toes-knees-schoulders (Behavioral)

NDD 6

Experimental

6-year-olds with neurodevelopmental disorders

干预措施: Laby 5-12 (Behavioral)

NDD 6

Experimental

6-year-olds with neurodevelopmental disorders

干预措施: M-ABC 2 (Behavioral)

NDD 6

Experimental

6-year-olds with neurodevelopmental disorders

干预措施: Stroop animals (Behavioral)

结局指标

主要结局

Tactile prediction at 6

时间窗: 6 years

Difference of amplitude between baseline and omission segment

Tactile prediction at 2

时间窗: 2 years

Difference of amplitude between baseline and omission segment

Repetition suppression at 2

时间窗: 2 years

Difference of tactile evoked potential amplitude between end and beginning of stimulation sequence

Repetition suppression at 6

时间窗: 6 years

Difference of tactile evoked potential amplitude between end and beginning of stimulation sequence

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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