Neural Correlates of Tactile Prediction

Premature Birth Clinical Trial

— DECODE  

Official title:

High Resolution Electroencephalography Exploration of Tactile Prediction Development

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04844853
• Other study ID #: 2020-A03208-31
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: July 2022
• Source: University Hospital, Caen
• Contact: Nadege Roche-Labarbe, PhD
• Phone: +33(0)649922568
• Email: nadege.roche[@]unicaen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurodevelopmental Disorders
• Premature Birth

Intervention

Device:
• electroencephalography
128-channel electroencephalography
• 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.
• Head-toes-knees-schoulders
Following motor commands such as touch your head when they are congruent or incongruent.
• Laby 5-12
Test of motor planning using labyrinths
• M-ABC 2
Test of motor functions using various subtests of gross and fine motor function.
• Stroop animals
Stroop test for preK children using animals instead of words

Locations

Country	Name	City	State
France	Comete U1075 Inserm Unicaen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repetition suppression at 2	Difference of tactile evoked potential amplitude between end and beginning of stimulation sequence	2 years
Primary	Repetition suppression at 6	Difference of tactile evoked potential amplitude between end and beginning of stimulation sequence	6 years
Primary	Tactile prediction at 2	Difference of amplitude between baseline and omission segment	2 years
Primary	Tactile prediction at 6	Difference of amplitude between baseline and omission segment	6 years