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Clinical Trials/NCT02989116
NCT02989116
Unknown
Not Applicable

Executive Training and Brain in School-Age Children

University Hospital, Caen1 site in 1 country150 target enrollmentOctober 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Children
Sponsor
University Hospital, Caen
Enrollment
150
Locations
1
Primary Endpoint
Change in brain functional BOLD activity after one month of executive training as assessed by MRI in regions subtending executive functioning.
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
December 2019
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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.

Time Frame: 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 Outcomes

  • Genetic variations measured by Single Nucleotide Polymorphism (SNP) genotyping(Pretest (t0))
  • Sulcal morphometry measured by anatomical MRI(Pretest (t0))

Study Sites (1)

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