Executive Training and Brain in Children (APEX)

Caen University Hospital

Status: Unknown

Conditions: Healthy Children; Preterm Birth

Treatments: Behavioral: Cognitive testing; Procedure: Brain Magnetic Resonance Imaging; Behavioral: Inhibition training; Behavioral: Active control training; Behavioral: Working memory training; Behavioral: Mindfulness training; Genetic: Saliva collection

Study type: Interventional

Funder types: Other

Identifiers

NCT02989116

2015-A00383-46

15-045 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 9 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 5 patient groups

Preterm Inhibition

Experimental group

Description:

In children born very preterm: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing

Treatment:

Behavioral: Cognitive testing

Genetic: Saliva collection

Behavioral: Inhibition training

Procedure: Brain Magnetic Resonance Imaging

Full-term Inhibition

Experimental group

Description:

In children born full-term: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing

Treatment:

Behavioral: Cognitive testing

Genetic: Saliva collection

Behavioral: Inhibition training

Procedure: Brain Magnetic Resonance Imaging

Full-term Working memory

Experimental group

Description:

In children born full-term: Working memory training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing

Treatment:

Behavioral: Cognitive testing

Genetic: Saliva collection

Behavioral: Working memory training

Procedure: Brain Magnetic Resonance Imaging

Full-term Mindfulness

Experimental group

Description:

In children born full-term: Mindfulness training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing

Treatment:

Behavioral: Cognitive testing

Behavioral: Mindfulness training

Genetic: Saliva collection

Procedure: Brain Magnetic Resonance Imaging

Full-term Active control

Active Comparator group

Description:

In children born full-term: Active control training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing

Treatment:

Behavioral: Cognitive testing

Genetic: Saliva collection

Procedure: Brain Magnetic Resonance Imaging

Behavioral: Active control training