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| ID | Type | Description | Link |
|---|---|---|---|
| 15-045 | Other Identifier | University Hospital, Caen |
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| Name | Class |
|---|---|
| National Research Agency, France | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preterm Inhibition | Experimental | In children born very preterm: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing |
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| Full-term Inhibition | Experimental | In children born full-term: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing |
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| Full-term Working memory | Experimental | In children born full-term: Working memory training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing |
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| Full-term Mindfulness | Experimental | In children born full-term: Mindfulness training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhibition training | Behavioral | Inhibition training on a tactile tablet for a month (20 sessions of 15 min) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | 3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pretest (t0) |
| Genetic variations measured by Single Nucleotide Polymorphism (SNP) genotyping |
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Inclusion Criteria for all children:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bernard Guillois, Professor | Contact | 02.31.25.27.64 | +33 | guillois-b@chu-caen.fr |
| Olivier Houdé, Professor | Contact | 01.40.46.29.95 | +33 | olivier.houde@parisdescartes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Olivier Houdé, Professor | University of Paris 5 - Rene Descartes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GIP Cyceron | Recruiting | Caen | 14074 | France |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D007266 | Inhibition, Psychological |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| ID | Term |
|---|---|
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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| Full-term Active control | Active Comparator | In children born full-term: Active control training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing |
|
| Working memory training | Behavioral | Working memory training on a tactile tablet for a month (20 sessions of 15 min) |
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| Mindfulness training | Behavioral | Mindfulness training on a tactile tablet for a month (20 sessions of 15 min) |
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| Active control training | Behavioral | Active control training on a tactile tablet for a month (20 sessions of 15 min) |
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| Saliva collection | Genetic | Collection of a saliva sample for genotyping |
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| Brain Magnetic Resonance Imaging | Procedure | Structural and functional MRI |
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| Cognitive testing | Behavioral | Battery of cognitive and academic tasks on executive functions |
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Assessing the impact of the different genotypes on behavioral and brain changes associated to a one-month executive training. |
| Pretest (t0) |
| D000091642 | Urogenital Diseases |
| D001519 | Behavior |