An interventional study of Inhibition training and Working memory training in Healthy Children and Preterm Birth, sponsored by University Hospital, Caen. Status unknown at 1 site in France. Open to participants aged 9 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-12.
Sponsored by University Hospital, Caen · Not applicable, Interventional, and Basic science
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.
2,557 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 150 is above the median of 84 across 1,691 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.
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Inclusion Criteria for all children:
Inclusion criterion for non preterm children only:
Inclusion criterion for preterm children only:
Exclusion Criteria for all participants:
In children born very preterm: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Behavioral: Inhibition training · Genetic: Saliva collection · Procedure: Brain Magnetic Resonance Imaging · Behavioral: Cognitive testing
In children born full-term: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Behavioral: Inhibition training · Genetic: Saliva collection · Procedure: Brain Magnetic Resonance Imaging · Behavioral: Cognitive testing
In children born full-term: Working memory training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Behavioral: Working memory training · Genetic: Saliva collection · Procedure: Brain Magnetic Resonance Imaging · Behavioral: Cognitive testing
In children born full-term: Mindfulness training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Behavioral: Mindfulness training · Genetic: Saliva collection · Procedure: Brain Magnetic Resonance Imaging · Behavioral: Cognitive testing
In children born full-term: Active control training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Behavioral: Active control training · Genetic: Saliva collection · Procedure: Brain Magnetic Resonance Imaging · Behavioral: Cognitive testing
Inhibition training on a tactile tablet for a month (20 sessions of 15 min)
Working memory training on a tactile tablet for a month (20 sessions of 15 min)
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)
Collection of a saliva sample for genotyping
Structural and functional MRI
Battery of cognitive and academic tasks on executive functions
Change in brain functional BOLD activity after one month of executive training as assessed by MRI in regions subtending executive functioning.
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.
Time frame: 3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months)
Change in brain cortical structure after one month of executive training as assessed by anatomical MRI in regions subtending executive functioning.
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
Time frame: 3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months)
Change in cognitive behavioral measures after one month of executive training as assessed by cognitive testing
The cognitive testing session includes several tasks assessing executive functioning under different conditions. Will be investigated: 3.a. Response Time 3.b. Accuracy
Time frame: 3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months)
Sulcal morphometry measured by anatomical MRI
Assessing the impact of the early determined sulcal morphometry on behavioral and brain changes associated to a one-month executive training.
Time frame: Pretest (t0)
Genetic variations measured by Single Nucleotide Polymorphism (SNP) genotyping
Assessing the impact of the different genotypes on behavioral and brain changes associated to a one-month executive training.
Time frame: Pretest (t0)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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University Hospital, Caen