NCT04844853

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

August 24, 2022

Status Verified

July 1, 2022

Enrollment Period

2.1 years

First QC Date

April 2, 2021

Last Update Submit

August 23, 2022

Conditions

Neurodevelopmental DisordersPremature Birth

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (4)

Preterm 2

EXPERIMENTAL

2-year-olds born prematurely

Device: electroencephalographyDevice: Tactile stimulation

Term 2

EXPERIMENTAL

2-year-olds born at term

Device: electroencephalographyDevice: Tactile stimulation

Typical 6

EXPERIMENTAL

6-year-olds with typical developement

Device: electroencephalographyDevice: Tactile stimulationBehavioral: Attention Network task (computerized)Behavioral: Head-toes-knees-schouldersBehavioral: Laby 5-12Behavioral: M-ABC 2Behavioral: Stroop animals

NDD 6

EXPERIMENTAL

6-year-olds with neurodevelopmental disorders

Device: electroencephalographyDevice: Tactile stimulationBehavioral: Attention Network task (computerized)Behavioral: Head-toes-knees-schouldersBehavioral: Laby 5-12Behavioral: M-ABC 2Behavioral: Stroop animals

Interventions

electroencephalographyDEVICE

128-channel electroencephalography

Also known as: EEG
NDD 6Preterm 2Term 2Typical 6
Tactile stimulationDEVICE

Vibrotactile sequence on the forearm

NDD 6Preterm 2Term 2Typical 6
Attention Network task (computerized)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.

Also known as: Child ANT, flankers task
NDD 6Typical 6
Head-toes-knees-schouldersBEHAVIORAL

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

Also known as: HTKS
NDD 6Typical 6
Laby 5-12BEHAVIORAL

Test of motor planning using labyrinths

NDD 6Typical 6
M-ABC 2BEHAVIORAL

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

NDD 6Typical 6
Stroop animalsBEHAVIORAL

Stroop test for preK children using animals instead of words

NDD 6Typical 6

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Severe IQ deficit or language impairment
  • Psychotropic medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comete U1075 Inserm Unicaen

Caen, 13032, France

RECRUITING

MeSH Terms

Conditions

Neurodevelopmental DisordersPremature Birth

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Mental DisordersObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Central Study Contacts

Nadege Roche-Labarbe, PhD

CONTACT

+33(0)649922568nadege.roche@unicaen.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2021

First Posted

April 14, 2021

Study Start

April 1, 2021

Primary Completion

April 30, 2023

Study Completion

September 30, 2023

Last Updated

August 24, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)