Executive Training and Brain in Children

Study Overview
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Brief Summary
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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.

Official Title
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Executive Training and Brain in School-Age Children

Conditions
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Healthy Children, Preterm Birth

Intervention / Treatment
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* Behavioral: Inhibition training
* Behavioral: Working memory training
* Behavioral: Mindfulness training
* Behavioral: Active control training
* Genetic: Saliva collection
* Procedure: Brain Magnetic Resonance Imaging
* Behavioral: Cognitive testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for all children: 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 Inclusion criterion for non preterm children only: - Full term pregnancy with no abnormal event (>= 37 weeks of amenorrhea) Inclusion criterion for preterm children only: - Delivery before 33 weeks of amenorrhea Exclusion Criteria for all participants: 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. 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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preterm Inhibition<br>In children born very preterm: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing | Behavioral: Inhibition training<br>* Inhibition training on a tactile tablet for a month (20 sessions of 15 min)<br>Genetic: Saliva collection<br>* Collection of a saliva sample for genotyping<br>Procedure: Brain Magnetic Resonance Imaging<br>* Structural and functional MRI<br>Behavioral: Cognitive testing<br>* Battery of cognitive and academic tasks on executive functions<br>|
| Experimental: Full-term Inhibition<br>In children born full-term: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing | Behavioral: Inhibition training<br>* Inhibition training on a tactile tablet for a month (20 sessions of 15 min)<br>Genetic: Saliva collection<br>* Collection of a saliva sample for genotyping<br>Procedure: Brain Magnetic Resonance Imaging<br>* Structural and functional MRI<br>Behavioral: Cognitive testing<br>* Battery of cognitive and academic tasks on executive functions<br>|
| Experimental: Full-term Working memory<br>In children born full-term: Working memory training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing | Behavioral: Working memory training<br>* Working memory training on a tactile tablet for a month (20 sessions of 15 min)<br>Genetic: Saliva collection<br>* Collection of a saliva sample for genotyping<br>Procedure: Brain Magnetic Resonance Imaging<br>* Structural and functional MRI<br>Behavioral: Cognitive testing<br>* Battery of cognitive and academic tasks on executive functions<br>|
| Experimental: Full-term Mindfulness<br>In children born full-term: Mindfulness training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing | Behavioral: Mindfulness training<br>* Mindfulness training on a tactile tablet for a month (20 sessions of 15 min)<br>Genetic: Saliva collection<br>* Collection of a saliva sample for genotyping<br>Procedure: Brain Magnetic Resonance Imaging<br>* Structural and functional MRI<br>Behavioral: Cognitive testing<br>* Battery of cognitive and academic tasks on executive functions<br>|
| Active Comparator: Full-term Active control<br>In children born full-term: Active control training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing | Behavioral: Active control training<br>* Active control training on a tactile tablet for a month (20 sessions of 15 min)<br>Genetic: Saliva collection<br>* Collection of a saliva sample for genotyping<br>Procedure: Brain Magnetic Resonance Imaging<br>* Structural and functional MRI<br>Behavioral: Cognitive testing<br>* Battery of cognitive and academic tasks on executive functions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Pretest (t0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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