APEX: Executive Training and Brain in Children

Sponsor

University Hospital, Caen (Other)

Overall Status

Unknown status

CT.gov ID

NCT02989116

Collaborator

National Research Agency, France (Other)

150

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Children Preterm Birth	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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

Executive Training and Brain in School-Age Children

Study Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 testing [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

Secondary Outcome Measures

Sulcal morphometry measured by anatomical MRI [Pretest (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) genotyping [Pretest (t0)]
Assessing the impact of the different genotypes on behavioral and brain changes associated to a one-month executive training.

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 10 Years

Sexes Eligible for Study:

All

Accepts 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