Neural Correlates of Tactile Prediction (DECODE)

Caen University Hospital

Status: Enrolling

Conditions: Neurodevelopmental Disorders; Premature Birth

Treatments: Device: Tactile stimulation; Behavioral: Stroop animals; Behavioral: Head-toes-knees-schoulders; Device: electroencephalography; Behavioral: Attention Network task (computerized); Behavioral: Laby 5-12; Behavioral: M-ABC 2

Study type: Interventional

Funder types: Other

Identifiers

NCT04844853

2020-A03208-31

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 2 to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Preterm 2

Experimental group

Description:

2-year-olds born prematurely

Treatment:

Device: Tactile stimulation

Device: electroencephalography

Term 2

Experimental group

Description:

2-year-olds born at term

Treatment:

Device: Tactile stimulation

Device: electroencephalography

Typical 6

Experimental group

Description:

6-year-olds with typical developement

Treatment:

Behavioral: Laby 5-12

Device: Tactile stimulation

Behavioral: Stroop animals

Behavioral: M-ABC 2

Behavioral: Head-toes-knees-schoulders

Behavioral: Attention Network task (computerized)

Device: electroencephalography

NDD 6

Experimental group

Description:

6-year-olds with neurodevelopmental disorders

Treatment:

Behavioral: Laby 5-12

Device: Tactile stimulation

Behavioral: Stroop animals

Behavioral: M-ABC 2

Behavioral: Head-toes-knees-schoulders

Behavioral: Attention Network task (computerized)

Device: electroencephalography