Neural Correlates of Tactile Prediction (DECODE)

High Resolution Electroencephalography Exploration of Tactile Prediction Development

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.

Study Overview

• Status: Recruiting
• Conditions: Premature Birth; Neurodevelopmental Disorders
• Intervention / Treatment: Device: electroencephalography; Device: Tactile stimulation; Behavioral: Attention Network task (computerized); Behavioral: Head-toes-knees-schoulders; Behavioral: Laby 5-12; Behavioral: M-ABC 2; Behavioral: Stroop animals

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 13032
    • Recruiting
    • Comete U1075 Inserm Unicaen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preterm 2; 2-year-olds born prematurely	Device: electroencephalography; 128-channel electroencephalography; Other Names: EEG; Device: Tactile stimulation; Vibrotactile sequence on the forearm
Experimental: Term 2; 2-year-olds born at term	Device: electroencephalography; 128-channel electroencephalography; Other Names: EEG; Device: Tactile stimulation; Vibrotactile sequence on the forearm
Experimental: Typical 6; 6-year-olds with typical developement	Device: electroencephalography; 128-channel electroencephalography; Other Names: EEG; Device: Tactile stimulation; Vibrotactile sequence on the forearm; Behavioral: Attention Network task (computerized); Computer-based game challenging orienting and executive attention. The subject must chose which side an animal is going, using left and right buttons, depending on the validity of a cue and the congruency of flankers.; Other Names: Child ANT, flankers task; Behavioral: Head-toes-knees-schoulders; Following motor commands such as touch your head when they are congruent or incongruent.; Other Names: HTKS; Behavioral: Laby 5-12; Test of motor planning using labyrinths; Behavioral: M-ABC 2; Test of motor functions using various subtests of gross and fine motor function.; Behavioral: Stroop animals; Stroop test for preK children using animals instead of words
Experimental: NDD 6; 6-year-olds with neurodevelopmental disorders	Device: electroencephalography; 128-channel electroencephalography; Other Names: EEG; Device: Tactile stimulation; Vibrotactile sequence on the forearm; Behavioral: Attention Network task (computerized); Computer-based game challenging orienting and executive attention. The subject must chose which side an animal is going, using left and right buttons, depending on the validity of a cue and the congruency of flankers.; Other Names: Child ANT, flankers task; Behavioral: Head-toes-knees-schoulders; Following motor commands such as touch your head when they are congruent or incongruent.; Other Names: HTKS; Behavioral: Laby 5-12; Test of motor planning using labyrinths; Behavioral: M-ABC 2; Test of motor functions using various subtests of gross and fine motor function.; Behavioral: Stroop animals; Stroop test for preK children using animals instead of words

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: April 2, 2021
• First Submitted That Met QC Criteria: April 9, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Neurodevelopmental Disorders
• Other Study ID Numbers: 2020-A03208-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No