Clinical trial NCT02989116: Executive Training and Brain in Children
Official title: Executive Training and Brain in School-Age Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Inhibition
Working Memory
Metacognition
Mindfulness
Preterm children
Developmental Psychology
Developmental cognitive neuroscience
Touch screen tablet
Adaptive training
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: National Research Agency, France
First posted: 2016-12-12
Enrollment: 150
Sex: ALL
Minimum age (years): 9
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in brain functional BOLD activity after one month of executive training as assessed by MRI in regions subtending executive functioning.
timeFrame: 3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months)
measure: Change in brain cortical structure after one month of executive training as assessed by anatomical MRI in regions subtending executive functioning.
timeFrame: 3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months)
measure: Change in cognitive behavioral measures after one month of executive training as assessed by cognitive testing
timeFrame: 3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months)
Secondary outcomes:
measure: Sulcal morphometry measured by anatomical MRI
timeFrame: Pretest (t0)
measure: Genetic variations measured by Single Nucleotide Polymorphism (SNP) genotyping
timeFrame: Pretest (t0)
Other outcomes:
Locations:
city: Caen
country: France
facility: GIP Cyceron
Study officials:
affiliation: University of Paris 5 - Rene Descartes
name: Olivier Houdé, Professor
role: PRINCIPAL_INVESTIGATOR
References: