Healthy VolunteersMASKNCT02858752
Memory and Attention in Healthy Children
A study testing Experience 1 : Auditory and Visual Discrimination, Experience 2 : Passive and Active Auditory Perception and Experience 3 : Visual Attention Training in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Experience 1 : Auditory and Visual Discrimination, Experience 2 : Passive and Active Auditory Perception and Experience 3 : Visual Attention Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 6 Oct 2016to 6 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Femme Mère Enfant
Lyon, 69500
Julia JUNG, MD, PHD, (0)4 27 85 60 53 ext. +33, julien.jung@inserm.fr
About this study
Official title: 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).
- Conditions
- Healthy Volunteers
- Being tested
- Experience 1 : Auditory and Visual Discrimination, Experience 2 : Passive and Active Auditory Perception, Experience 3 : Visual Attention Training, Experience 4 : Attention and Distractibility, Experience 5 : Sustained Visual Attention
- Keywords
- Attention, Short-term memory, Aural Memory, Visual Memory, Child, EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experience 1 : Auditory and Visual DiscriminationOther
Neuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons.
Experience 2 : Passive and Active Auditory PerceptionOther
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 TrainingOther
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 DistractibilityOther
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 AttentionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Experience 1 : Auditory and Visual Discrimination; Other: Experience 2 : Passive and Active Auditory Perception; Other: Experience 3 : Visual Attention Training; Other: Experience 4 : Attention and Distractibility; Other: Experience 5 : Sustained Visual Attention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological tests: Proportion of accurate answers
Measured: 2 months
Neuropsychological tests: reaction time of answers (seconds)
Measured: 2 months
Neurophysiological tests: Event-related potentials in response to auditory and visual stimulations
Measured: 2 months
Secondary outcomes (3)
Proportion of accurate answers according to age range of children
Measured: 2 months
reaction time of answers (seconds) according to age range of children
Measured: 2 months
Event-related potentials in response to auditory and visual stimulations according to age range of children
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study start6 Oct 2016
- Primary completion6 Oct 2020 (estimated)
- Study completion6 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858752
- Sponsor's protocol ID
- 69HCL15_0711
- Acronym
- MASK
- Status last verified
- Aug 2017
- First submitted
- 29 Jul 2016
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory, Auditory and Visual Attention in Healthy Children: Neurophysiological and Electrophysiological Aspects
- ClinicalTrials.gov ID
- NCT02858752
- Acronym / sponsor ID
- MASK / 69HCL15_0711
- Conditions
- Healthy Volunteers
- Keywords
- Attention, Short-term memory, Aural Memory, Visual Memory, Child, EEG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 6 Oct 2016 (actual)
- Primary completion
- 6 Oct 2020 (estimated)
- Study completion
- 6 Oct 2020 (estimated)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Children | Experimental | Other: Experience 1 : Auditory and Visual Discrimination, Other: Experience 2 : Passive and Active Auditory Perception, Other: Experience 3 : Visual Attention Training, Other: Experience 4 : Attention and Distractibility, Other: Experience 5 : Sustained Visual AttentionMemory 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. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experience 1 : Auditory and Visual DiscriminationNeuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons. | Other | Healthy Children |
| Experience 2 : Passive and Active Auditory PerceptionNeuropsychological 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. | Other | Healthy Children |
| Experience 3 : Visual Attention TrainingThis 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. | Other | Healthy Children |
| Experience 4 : Attention and DistractibilityNeuropsychological 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. | Other | Healthy Children |
| Experience 5 : Sustained Visual AttentionNeuropsychological 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. | Other | Healthy Children |
Primary outcome
Neuropsychological tests: Proportion of accurate answers
Time frame: 2 months
Neuropsychological tests: reaction time of answers (seconds)
Time frame: 2 months
Neurophysiological tests: Event-related potentials in response to auditory and visual stimulations
Time frame: 2 months
3 secondary outcomes
Proportion of accurate answers according to age range of children
Time frame: 2 months
reaction time of answers (seconds) according to age range of children
Time frame: 2 months
Event-related potentials in response to auditory and visual stimulations according to age range of children
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experience 1 : Auditory and Visual Discrimination, Experience 2 : Passive and Active Auditory Perception and Experience 3 : Visual Attention Training in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien JUNG, MD, PhD ((0)4 27 85 60 53 ext. +33, julien.jung@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological tests: Proportion of accurate answers (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.