Neural Correlates of Tactile Prediction

NCT ID: NCT04844853

Last Updated: 2022-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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Neurodevelopmental Disorders Premature Birth

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Preterm 2

2-year-olds born prematurely

Group Type EXPERIMENTAL

electroencephalography

Intervention Type DEVICE

128-channel electroencephalography

Tactile stimulation

Intervention Type DEVICE

Vibrotactile sequence on the forearm

Term 2

2-year-olds born at term

Group Type EXPERIMENTAL

electroencephalography

Intervention Type DEVICE

128-channel electroencephalography

Tactile stimulation

Intervention Type DEVICE

Vibrotactile sequence on the forearm

Typical 6

6-year-olds with typical developement

Group Type EXPERIMENTAL

electroencephalography

Intervention Type DEVICE

128-channel electroencephalography

Tactile stimulation

Intervention Type DEVICE

Vibrotactile sequence on the forearm

Attention Network task (computerized)

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Following motor commands such as touch your head when they are congruent or incongruent.

Laby 5-12

Intervention Type BEHAVIORAL

Test of motor planning using labyrinths

M-ABC 2

Intervention Type BEHAVIORAL

Test of motor functions using various subtests of gross and fine motor function.

Stroop animals

Intervention Type BEHAVIORAL

Stroop test for preK children using animals instead of words

NDD 6

6-year-olds with neurodevelopmental disorders

Group Type EXPERIMENTAL

electroencephalography

Intervention Type DEVICE

128-channel electroencephalography

Tactile stimulation

Intervention Type DEVICE

Vibrotactile sequence on the forearm

Attention Network task (computerized)

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Following motor commands such as touch your head when they are congruent or incongruent.

Laby 5-12

Intervention Type BEHAVIORAL

Test of motor planning using labyrinths

M-ABC 2

Intervention Type BEHAVIORAL

Test of motor functions using various subtests of gross and fine motor function.

Stroop animals

Intervention Type BEHAVIORAL

Stroop test for preK children using animals instead of words

Interventions

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electroencephalography

128-channel electroencephalography

Intervention Type DEVICE

Tactile stimulation

Vibrotactile sequence on the forearm

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Head-toes-knees-schoulders

Following motor commands such as touch your head when they are congruent or incongruent.

Intervention Type BEHAVIORAL

Laby 5-12

Test of motor planning using labyrinths

Intervention Type BEHAVIORAL

M-ABC 2

Test of motor functions using various subtests of gross and fine motor function.

Intervention Type BEHAVIORAL

Stroop animals

Stroop test for preK children using animals instead of words

Intervention Type BEHAVIORAL

Other Intervention Names

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EEG Child ANT, flankers task HTKS

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Comete U1075 Inserm Unicaen

Caen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Nadege Roche-Labarbe, PhD

Role: CONTACT

+33(0)649922568

Facility Contacts

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Nadege Roche-Labarbe, PhD

Role: primary

Other Identifiers

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2020-A03208-31

Identifier Type: -

Identifier Source: org_study_id

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