Clinical trial NCT04844853: Neural Correlates of Tactile Prediction
Official title: High Resolution Electroencephalography Exploration of Tactile Prediction Development
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurodevelopmental Disorders
Premature Birth
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Repetition suppression at 2
timeFrame: 2 years
measure: Repetition suppression at 6
timeFrame: 6 years
measure: Tactile prediction at 2
timeFrame: 2 years
measure: Tactile prediction at 6
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Comete U1075 Inserm Unicaen
Study officials:
References: