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Executive Training and Brain in Children

Executive Training and Brain in School-Age Children

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02989116
Acronym
APEX
Enrollment
150
Registered
2016-12-12
Start date
2015-10-31
Completion date
2019-12-31
Last updated
2016-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

Inhibition training on a tactile tablet for a month (20 sessions of 15 min)

BEHAVIORALWorking memory training

Working memory training on a tactile tablet for a month (20 sessions of 15 min)

BEHAVIORALMindfulness training

Mindfulness training on a tactile tablet for a month (20 sessions of 15 min)

Active control training on a tactile tablet for a month (20 sessions of 15 min)

GENETICSaliva collection

Collection of a saliva sample for genotyping

Structural and functional MRI

BEHAVIORALCognitive testing

Battery of cognitive and academic tasks on executive functions

Sponsors

National Research Agency, France
CollaboratorOTHER
University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
9 Years to 10 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in brain functional BOLD activity after one month of executive training as assessed by MRI in regions subtending executive functioning.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.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 testing3 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

Secondary

MeasureTime frameDescription
Sulcal morphometry measured by anatomical MRIPretest (t0)Assessing the impact of the early determined sulcal morphometry on behavioral and brain changes associated to a one-month executive training.
Genetic variations measured by Single Nucleotide Polymorphism (SNP) genotypingPretest (t0)Assessing the impact of the different genotypes on behavioral and brain changes associated to a one-month executive training.

Countries

France

Contacts

Primary ContactBernard Guillois, Professor
guillois-b@chu-caen.fr02.31.25.27.64
Backup ContactOlivier Houdé, Professor
olivier.houde@parisdescartes.fr01.40.46.29.95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026