Memory and Attention in Healthy Children

Healthy Volunteers Clinical Trial

— MASK  

Official title:

Memory, Auditory and Visual Attention in Healthy Children: Neurophysiological and Electrophysiological Aspects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02858752
• Other study ID #: 69HCL15_0711
• Status: Recruiting
• Phase: N/A
• First received: July 29, 2016
• Last updated: August 8, 2017
• Start date: October 6, 2016
• Est. completion date: October 6, 2020

Study information

• Verified date: August 2017
• Source: Hospices Civils de Lyon
• Contact: Julien JUNG, MD, PhD
• Phone: (0)4 27 85 60 53
• Email: julien.jung[@]inserm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 6, 2020
• Est. primary completion date: October 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Experience 1 : Auditory and Visual Discrimination
Neuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons.
• Experience 2 : Passive and Active Auditory Perception
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.
• Experience 3 : Visual Attention Training
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.
• Experience 4 : Attention and Distractibility
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.
• Experience 5 : Sustained Visual Attention
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.

Locations

Country	Name	City	State
France	Hopital Femme Mère Enfant	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychological tests: Proportion of accurate answers		2 months
Primary	Neuropsychological tests: reaction time of answers (seconds)		2 months
Primary	Neurophysiological tests: Event-related potentials in response to auditory and visual stimulations		2 months
Secondary	Proportion of accurate answers according to age range of children		2 months
Secondary	reaction time of answers (seconds) according to age range of children		2 months
Secondary	Event-related potentials in response to auditory and visual stimulations according to age range of children		2 months