Healthy ChildrenAPEXNCT02989116
Executive Training and Brain in Children
A study testing Inhibition training, Working memory training and Mindfulness training in people with Healthy Children and Preterm Birth, run by University Hospital, Caen at 1 site in France.
Trial summary
The purpose of this study is to determine whether a daily executive training to cognitive inhibition, working memory or mindfulness as compared to an active control condition has a near- and far-transfer impact on brain and behavioral measures as collected in children aged 9-10 years, either born preterm or full-term. Read more about this study
- Who is it for?
- Ages 9 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children, Preterm Birth
- What is being tested?
- Inhibition training, Working memory training and Mindfulness training
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to Dec 2019
- 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 9 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female
- Aged 9-10 years at inclusion
- French school curriculum (since 1st grade)
- Fully informed through the dedicated booklet
- Both parents gave their written consent
- Normal medical, neurological and brain imaging assessment
- Full term pregnancy with no abnormal event (>= 37 weeks of amenorrhea)
- Delivery before 33 weeks of amenorrhea
Who cannot join
- Age over or under 9-10 years old at inclusion
- Monozygotic twins
- Restrictions to a Magnetic Resonance brain imaging exam: claustrophobia, metallic elements (cardiac implants, cochlear implants, metallic elements in the brain or the eyes and being close to the nervous system, metallic prothesis, braces), restless participants.
- Sudden cognitive impairments due to a stroke, head injury associated with loss of consciousness for more than one hour or encephalitis.
- Chronic neurological, psychiatric, infectious or liver condition, endocrine disruption.
- Past or current medical condition: cancer, diabetes, chronic lung condition, cardiac, metabolic, hematological, endocrine or immunological disorder.
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- Medication assumed to interfere with brain imaging measures (psychotropics, hypnotics, anxiolytics, neuroleptics, benzodiazepine, steroidal anti-inflammatory, anti-epileptics, painkillers, muscle relaxants).
- Left-sided handedness
- Colour blindness or non-corrected visual disturbances
- Diagnosed developmental disorders
- Diagnosed cerebral palsy
- Diagnosed Fine motor disturbances
- Parents not affiliated to the Social Security
- Parents not able to join at each time of the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
GIP Cyceron
Caen, 14074
Olivier Houdé, Professor, 01.40.46.29.95 ext. +33, olivier.houde@parisdescartes.fr
Grégoire Borst, Professor, 01.40.46.30.04 ext. +33, gregoire.borst@parisdescartes.fr
About this study
Official title: Executive Training and Brain in School-Age Children
The purpose of this study is to determine whether a daily executive training to cognitive inhibition, working memory or mindfulness as compared to an active control condition has a near- and far-transfer impact on brain and behavioral measures as collected in children aged 9-10 years, either born preterm or full-term.
- Conditions
- Healthy Children, Preterm Birth
- Being tested
- Inhibition training, Working memory training, Mindfulness training, Active control training, Saliva collection
- Keywords
- Learning, Executive functions, Cognitive control, Prefrontal Cortex, Typically developing children, Genotype, Functional Magnetic Resonance Imaging, Structural Magnetic Resonance Imaging, Inhibition, Working Memory, Metacognition, Mindfulness, Preterm children, Developmental Psychology, Developmental cognitive neuroscience, Touch screen tablet, Adaptive training
- Medical subject headings
- Premature Birth, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhibition trainingBehavioural
Inhibition training on a tactile tablet for a month (20 sessions of 15 min)
Working memory trainingBehavioural
Working memory training on a tactile tablet for a month (20 sessions of 15 min)
Mindfulness trainingBehavioural
Mindfulness training on a tactile tablet for a month (20 sessions of 15 min)
Active control trainingBehavioural
Active control training on a tactile tablet for a month (20 sessions of 15 min)
Saliva collectionGenetic
Collection of a saliva sample for genotyping
Brain Magnetic Resonance ImagingProcedure or surgery
Structural and functional MRI
Cognitive testingBehavioural
Battery of cognitive and academic tasks on executive functions
| Study group | Role | What they receive |
|---|---|---|
| Preterm Inhibition | Experimental | In children born very preterm:
Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing Receives: Behavioral: Inhibition training; Genetic: Saliva collection; Procedure: Brain Magnetic Resonance Imaging; Behavioral: Cognitive testing |
| Full-term Inhibition | Experimental | In children born full-term:
Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing Receives: Behavioral: Inhibition training; Genetic: Saliva collection; Procedure: Brain Magnetic Resonance Imaging; Behavioral: Cognitive testing |
| Full-term Working memory | Experimental | In children born full-term:
Working memory training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing Receives: Behavioral: Working memory training; Genetic: Saliva collection; Procedure: Brain Magnetic Resonance Imaging; Behavioral: Cognitive testing |
| Full-term Mindfulness | Experimental | In children born full-term:
Mindfulness training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing Receives: Behavioral: Mindfulness training; Genetic: Saliva collection; Procedure: Brain Magnetic Resonance Imaging; Behavioral: Cognitive testing |
| Full-term Active control | Active comparator | In children born full-term:
Active control training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing Receives: Behavioral: Active control training; Genetic: Saliva collection; Procedure: Brain Magnetic Resonance Imaging; Behavioral: Cognitive testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain functional BOLD activity after one month of executive training as assessed by MRI in regions subtending executive functioning.
Change in brain activation will be measured with functional magnetic resonance imaging (fMRI) during two different tasks: a Stop Signal task assessing inhibition and a Dot task assessing working memory.
Measured: 3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months)
Change in brain cortical structure after one month of executive training as assessed by anatomical MRI in regions subtending executive functioning.
Change in brain cortical structure will be measured with anatomical magnetic resonance imaging (aMRI) using four different measures:
2.a. grey matter volume 2.b. cortical thickness 2.c. cortical surface area 2.d. curvature
Measured: 3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months)
Change in cognitive behavioral measures after one month of executive training as assessed by cognitive testing
The cognitive testing session includes several tasks assessing executive functioning under different conditions. Will be investigated:
3.a. Response Time 3.b. Accuracy
Measured: 3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months)
Secondary outcomes (2)
Sulcal morphometry measured by anatomical MRI
Assessing the impact of the early determined sulcal morphometry on behavioral and brain changes associated to a one-month executive training.
Measured: Pretest (t0)
Genetic variations measured by Single Nucleotide Polymorphism (SNP) genotyping
Assessing the impact of the different genotypes on behavioral and brain changes associated to a one-month executive training.
Measured: Pretest (t0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ChildrenStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France
- Responsible party
- Sponsor
- Investigators
- Olivier Houdé, Professor, Principal investigator, University of Paris 5 - Rene Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989116
- Sponsor's protocol ID
- 2015-A00383-46
- Other IDs
- 15-045
- Acronym
- APEX
- Status last verified
- Nov 2016
- First submitted
- 27 May 2016
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Training and Brain in School-Age Children
- ClinicalTrials.gov ID
- NCT02989116
- Acronym / sponsor ID
- APEX / 2015-A00383-46
- Conditions
- Healthy Children, Preterm Birth
- Keywords
- Learning, Executive functions, Cognitive control, Prefrontal Cortex, Typically developing children, Genotype, Functional Magnetic Resonance Imaging, Structural Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- National Research Agency, France
- Study start
- Oct 2015
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 12 Dec 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.
The purpose of this study is to determine whether a daily executive training to cognitive inhibition, working memory or mindfulness as compared to an active control condition has a near- and far-transfer impact on brain and behavioral measures as collected in children aged 9-10 years, either born preterm or full-term.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Preterm Inhibition | Experimental | Behavioral: Inhibition training, Genetic: Saliva collection, Procedure: Brain Magnetic Resonance Imaging, Behavioral: Cognitive testingIn children born very preterm: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing |
| Full-term Inhibition | Experimental | Behavioral: Inhibition training, Genetic: Saliva collection, Procedure: Brain Magnetic Resonance Imaging, Behavioral: Cognitive testingIn children born full-term: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing |
| Full-term Working memory | Experimental | Behavioral: Working memory training, Genetic: Saliva collection, Procedure: Brain Magnetic Resonance Imaging, Behavioral: Cognitive testingIn children born full-term: Working memory training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing |
| Full-term Mindfulness | Experimental | Behavioral: Mindfulness training, Genetic: Saliva collection, Procedure: Brain Magnetic Resonance Imaging, Behavioral: Cognitive testingIn children born full-term: Mindfulness training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing |
| Full-term Active control | Active comparator | Behavioral: Active control training, Genetic: Saliva collection, Procedure: Brain Magnetic Resonance Imaging, Behavioral: Cognitive testingIn children born full-term: Active control training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing |
Who may qualify
- Ages
- 9 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Male or female
- Aged 9-10 years at inclusion
- French school curriculum (since 1st grade)
- Fully informed through the dedicated booklet
- Both parents gave their written consent
Key exclusion criteria (14 listed)
- Age over or under 9-10 years old at inclusion
- Monozygotic twins
- Restrictions to a Magnetic Resonance brain imaging exam: claustrophobia, metallic elements (cardiac implants, cochlear implants, metallic elements in the brain or the eyes and being close to the nervous system, metallic prothesis, braces), restless participants.
- Sudden cognitive impairments due to a stroke, head injury associated with loss of consciousness for more than one hour or encephalitis.
- Chronic neurological, psychiatric, infectious or liver condition, endocrine disruption.
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 |
|---|---|---|
| Inhibition trainingInhibition training on a tactile tablet for a month (20 sessions of 15 min) | Behavioural | Full-term Inhibition, Preterm Inhibition |
| Working memory trainingWorking memory training on a tactile tablet for a month (20 sessions of 15 min) | Behavioural | Full-term Working memory |
| Mindfulness trainingMindfulness training on a tactile tablet for a month (20 sessions of 15 min) | Behavioural | Full-term Mindfulness |
| Active control trainingActive control training on a tactile tablet for a month (20 sessions of 15 min) | Behavioural | Full-term Active control |
| Saliva collectionCollection of a saliva sample for genotyping | Genetic | Full-term Active control, Full-term Inhibition, Full-term Mindfulness, Full-term Working memory, Preterm Inhibition |
| Brain Magnetic Resonance ImagingStructural and functional MRI | Procedure or surgery | Full-term Active control, Full-term Inhibition, Full-term Mindfulness, Full-term Working memory, Preterm Inhibition |
| Cognitive testingBattery of cognitive and academic tasks on executive functions | Behavioural | Full-term Active control, Full-term Inhibition, Full-term Mindfulness, Full-term Working memory, Preterm Inhibition |
Primary outcome
Change in brain functional BOLD activity after one month of executive training as assessed by MRI in regions subtending executive functioning.
Time frame: 3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months)
Change in brain activation will be measured with functional magnetic resonance imaging (fMRI) during two different tasks: a Stop Signal task assessing inhibition and a Dot task assessing working memory.
Change in brain cortical structure after one month of executive training as assessed by anatomical MRI in regions subtending executive functioning.
Time frame: 3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months)
Change in brain cortical structure will be measured with anatomical magnetic resonance imaging (aMRI) using four different measures: 2.a. grey matter volume 2.b. cortical thickness 2.c. cortical surface area 2.d. curvature
Change in cognitive behavioral measures after one month of executive training as assessed by cognitive testing
Time frame: 3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months)
The cognitive testing session includes several tasks assessing executive functioning under different conditions. Will be investigated: 3.a. Response Time 3.b. Accuracy
2 secondary outcomes
Sulcal morphometry measured by anatomical MRI
Time frame: Pretest (t0)
Genetic variations measured by Single Nucleotide Polymorphism (SNP) genotyping
Time frame: Pretest (t0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Individual participant dataSharing planned: Undecided
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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.
Olivier Houdé, Professor principal investigator
University of Paris 5 - Rene Descartes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhibition training, Working memory training and Mindfulness training in people with Healthy Children and Preterm Birth, run by University Hospital, Caen 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 8 inclusion and 14 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 12 Dec 2016. 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 Bernard Guillois, Professor (02.31.25.27.64 ext. +33, guillois-b@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brain functional BOLD activity after one month of executive training as assessed by MRI in regions subtending executive functioning. (time frame: 3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 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 12 Dec 2016.