Executive Training and Brain in Children

Not Applicable

• Conditions: Preterm Birth; Healthy Children
• Interventions: Behavioral: Inhibition training; Behavioral: Working memory training; Behavioral: Active control training; Behavioral: Mindfulness training; Genetic: Saliva collection; Procedure: Brain Magnetic Resonance Imaging; Behavioral: Cognitive testing

• Registration Number: NCT02989116
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-05-27
• Status Verified: 2016-11
• Study First Submitted QC: 2016-12-07
• Last Update Submitted: 2016-12-07
• Study First Posted: 2016-12-12
• Last Update Posted: 2016-12-12
• Primary Completion: 2019-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preterm Inhibition	Saliva collection	In children born very preterm: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Preterm Inhibition	Cognitive testing	In children born very preterm: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Full-term Inhibition	Saliva collection	In children born full-term: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Preterm Inhibition	Inhibition training	In children born very preterm: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Preterm Inhibition	Brain Magnetic Resonance Imaging	In children born very preterm: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Full-term Inhibition	Cognitive testing	In children born full-term: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Full-term Mindfulness	Cognitive testing	In children born full-term: Mindfulness training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Full-term Working memory	Working memory training	In children born full-term: Working memory training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Full-term Working memory	Brain Magnetic Resonance Imaging	In children born full-term: Working memory training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Full-term Active control	Active control training	In children born full-term: Active control training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Full-term Active control	Cognitive testing	In children born full-term: Active control training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Full-term Inhibition	Inhibition training	In children born full-term: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Full-term Working memory	Saliva collection	In children born full-term: Working memory training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Full-term Inhibition	Brain Magnetic Resonance Imaging	In children born full-term: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Full-term Working memory	Cognitive testing	In children born full-term: Working memory training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Full-term Mindfulness	Brain Magnetic Resonance Imaging	In children born full-term: Mindfulness training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Full-term Active control	Brain Magnetic Resonance Imaging	In children born full-term: Active control training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Full-term Active control	Saliva collection	In children born full-term: Active control training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Full-term Mindfulness	Mindfulness training	In children born full-term: Mindfulness training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Full-term Mindfulness	Saliva collection	In children born full-term: Mindfulness training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing

Primary Outcome Measures

Name	Time	Method
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 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
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

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

GIP Cyceron; 🇫🇷 Caen, France