Preterm Birth Clinical Trial
— APEXOfficial title:
Executive Training and Brain in School-Age Children
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 2019 |
Est. primary completion date | October 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 9 Years to 10 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
France | GIP Cyceron | Caen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen | National Research Agency, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No |
Primary | 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) | No |
Primary | 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) | No |
Secondary | 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) | No |
Secondary | 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. | Pretest (t0) | No |
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