- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02858752
Memory and Attention in Healthy Children (MASK)
Memory, Auditory and Visual Attention in Healthy Children: Neurophysiological and Electrophysiological Aspects
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).
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lyon, France, 69500
- Recruiting
- Hôpital Femme Mère Enfant
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Contact:
- Julia JUNG, MD, PHD
- Phone Number: +33 (0)4 27 85 60 53
- Email: julien.jung@inserm.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Healthy Children
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.
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Neuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons.
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.
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.
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Neuropsychological tests: Proportion of accurate answers
Time Frame: 2 months
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2 months
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Neuropsychological tests: reaction time of answers (seconds)
Time Frame: 2 months
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2 months
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Neurophysiological tests: Event-related potentials in response to auditory and visual stimulations
Time Frame: 2 months
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2 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Proportion of accurate answers according to age range of children
Time Frame: 2 months
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2 months
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reaction time of answers (seconds) according to age range of children
Time Frame: 2 months
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2 months
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Event-related potentials in response to auditory and visual stimulations according to age range of children
Time Frame: 2 months
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2 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 69HCL15_0711
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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