NCT02858752

Brief Summary

This project studies memory and attention in healthy children aged from 5 to 17 years. The processes investigated are short term memory (auditory and visual) and attention. To characterize these processes involved in childhood, neuropsychological and neurophysiological assessments will be performed (using Electro-encephalography measures, behavioural responses and questionnaires).

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
400

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable healthy-volunteers

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

First Submitted

Initial submission to the registry

July 29, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 6, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2020

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

4 years

First QC Date

July 29, 2016

Last Update Submit

August 8, 2017

Conditions

Keywords

AttentionShort-term memoryAural MemoryVisual MemoryChildEEG

Outcome Measures

Primary Outcomes (3)

  • Neuropsychological tests: Proportion of accurate answers

    2 months

  • Neuropsychological tests: reaction time of answers (seconds)

    2 months

  • Neurophysiological tests: Event-related potentials in response to auditory and visual stimulations

    2 months

Secondary Outcomes (3)

  • Proportion of accurate answers according to age range of children

    2 months

  • reaction time of answers (seconds) according to age range of children

    2 months

  • Event-related potentials in response to auditory and visual stimulations according to age range of children

    2 months

Study Arms (1)

Healthy Children

EXPERIMENTAL

Memory and Attention in healthy children will be assessed non-invasively through behavioral and electrophysiological measures while participants will perform passive or active computer task involving auditory and/or visual perception.

Other: Experience 1 : Auditory and Visual DiscriminationOther: Experience 2 : Passive and Active Auditory PerceptionOther: Experience 3 : Visual Attention TrainingOther: Experience 4 : Attention and DistractibilityOther: Experience 5 : Sustained Visual Attention

Interventions

Neuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons.

Healthy Children

Neuropsychological tests consist in listening to sounds under 2 conditions, an active or a passive one, during which different auditory stimuli will be presented: frequent stimuli (standard) and rare stimuli (deviants). These two stimuli differ in some of their feature (height, duration, …). A third, very rare (novel) stimulus will also be used (the subject's first name). Responses will be provided using a response-button and feedback will be given at each response. EEG will be recorded all along to measure Neurophysiological signals.

Healthy Children

This experience aims at training visual attention through serious games. Children will play against an artificial intelligence and will focus their attention on one out of many possible targets (checkers, cards, boxes) presented on screen. Responses will be provided using a response-button, sometimes completed by an eye-tracking measure. Feedback will be given to the child after his response. EEG will be recorded all along to measure Neurophysiological signals.

Healthy Children

Neuropsychological tests consist in listening to sounds preceded by a visual cue indicating (or not) in which ear the sounds will be played. The subject Child should detect the target sound (e.g. a dog barking). In some trials, a distracting distraction will be introduced between the visual cue and the target sound. Responses will be provided using a response-button. EEG will be recorded all along to measure Neurophysiological signals.

Healthy Children

Neuropsychological tests consist in watching visual stimuli presented in 3 blocks of 3 minutes each, with a break of one minute between each block. The child has to detect the presence of a red letter in a pattern made of four letters (the three other letters are black). Behavioral responses will be provided using a response-button. EEG will be recorded all along to measure Neurophysiological signals.

Healthy Children

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Normal or corrected vision
  • No neurological and psychiatric antecedent.
  • No neuro-developmental disorder (dysphasia, dyslexia, dyspraxia, attention deficit disorder…)
  • Motivation to participate to the study
  • Signed parental informed consent authorizing their child to participate to the study

You may not qualify if:

  • Children educated in a specialized institution.
  • Subjects diagnosed with a neurological, psychiatric or neuro-developmental disorder
  • Subjects with hearing loss
  • Subjects with a visual impairment that cannot be corrected
  • Subjects with an organic or chronic disease that can affect cognitive functions.
  • Subjects who do not benefit from social security.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Femme Mère Enfant

Lyon, 69500, France

RECRUITING

Central Study Contacts

Julien JUNG, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2016

First Posted

August 8, 2016

Study Start

October 6, 2016

Primary Completion

October 6, 2020

Study Completion

October 6, 2020

Last Updated

August 9, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations