Executive Training and Brain in Children

Preterm Birth Clinical Trial

— APEX  

Official title:

Executive Training and Brain in School-Age Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02989116
• Other study ID #: 2015-A00383-46
• Secondary ID: 15-045
• Status: Recruiting
• Phase: N/A
• First received: May 27, 2016
• Last updated: December 7, 2016
• Start date: October 2015
• Est. completion date: December 2019

Study information

• Verified date: November 2016
• Source: University Hospital, Caen
• Contact: Bernard Guillois, Professor
• Phone: 02.31.25.27.64
• Email: guillois-b[@]chu-caen.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Children
• Premature Birth
• Preterm Birth

Intervention

Behavioral:
• Inhibition training
Inhibition training on a tactile tablet for a month (20 sessions of 15 min)
• Working memory training
Working memory training on a tactile tablet for a month (20 sessions of 15 min)
• Mindfulness training
Mindfulness training on a tactile tablet for a month (20 sessions of 15 min)
• Active control training
Active control training on a tactile tablet for a month (20 sessions of 15 min)

Genetic:
• Saliva collection
Collection of a saliva sample for genotyping

Procedure:
• Brain Magnetic Resonance Imaging
Structural and functional MRI

Behavioral:
• Cognitive testing
Battery of cognitive and academic tasks on executive functions

Locations

Country	Name	City	State
France	GIP Cyceron	Caen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	National Research Agency, France

Country where clinical trial is conducted

France, 

Outcome

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