Neural Correlates of Tactile Prediction

Not Applicable

• Conditions: Premature Birth; Neurodevelopmental Disorders

• Registration Number: NCT04844853
• Lead Sponsor: University Hospital, Caen

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-02
• Study First Submitted QC: 2021-04-09
• Study First Posted: 2021-04-14
• Status Verified: 2022-07
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-24
• Primary Completion: 2023-04-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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

Exclusion Criteria

• Severe IQ deficit or language impairment
• Psychotropic medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tactile prediction at 6	6 years	Difference of amplitude between baseline and omission segment
Tactile prediction at 2	2 years	Difference of amplitude between baseline and omission segment
Repetition suppression at 2	2 years	Difference of tactile evoked potential amplitude between end and beginning of stimulation sequence
Repetition suppression at 6	6 years	Difference of tactile evoked potential amplitude between end and beginning of stimulation sequence

Trial Locations

Locations (1)

Comete U1075 Inserm Unicaen; 🇫🇷 Caen, France