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Executive Training and Brain in Children (APEX)

Primary Purpose

Healthy Children, Preterm Birth

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Inhibition training
Working memory training
Mindfulness training
Active control training
Saliva collection
Brain Magnetic Resonance Imaging
Cognitive testing
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy Children focused on measuring Learning, Executive functions, Cognitive control, Prefrontal Cortex, Typically developing children, Genotype, Functional Magnetic Resonance Imaging, Structural Magnetic Resonance Imaging, Inhibition, Working Memory, Metacognition, Mindfulness, Preterm children, Developmental Psychology, Developmental cognitive neuroscience, Touch screen tablet, Adaptive training

Eligibility Criteria

9 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • GIP CyceronRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Preterm Inhibition

Full-term Inhibition

Full-term Working memory

Full-term Mindfulness

Full-term Active control

Arm Description

In children born very preterm: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing

In children born full-term: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing

In children born full-term: Working memory training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing

In children born full-term: Mindfulness training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing

In children born full-term: Active control training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing

Outcomes

Primary Outcome Measures

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.
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
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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 27, 2016
Last Updated
December 7, 2016
Sponsor
University Hospital, Caen
Collaborators
National Research Agency, France
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1. Study Identification

Unique Protocol Identification Number
NCT02989116
Brief Title
Executive Training and Brain in Children
Acronym
APEX
Official Title
Executive Training and Brain in School-Age Children
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
National Research Agency, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Children, Preterm Birth
Keywords
Learning, Executive functions, Cognitive control, Prefrontal Cortex, Typically developing children, Genotype, Functional Magnetic Resonance Imaging, Structural Magnetic Resonance Imaging, Inhibition, Working Memory, Metacognition, Mindfulness, Preterm children, Developmental Psychology, Developmental cognitive neuroscience, Touch screen tablet, Adaptive training

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preterm Inhibition
Arm Type
Experimental
Arm Description
In children born very preterm: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Arm Title
Full-term Inhibition
Arm Type
Experimental
Arm Description
In children born full-term: Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Arm Title
Full-term Working memory
Arm Type
Experimental
Arm Description
In children born full-term: Working memory training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Arm Title
Full-term Mindfulness
Arm Type
Experimental
Arm Description
In children born full-term: Mindfulness training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Arm Title
Full-term Active control
Arm Type
Active Comparator
Arm Description
In children born full-term: Active control training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Intervention Type
Behavioral
Intervention Name(s)
Inhibition training
Intervention Description
Inhibition training on a tactile tablet for a month (20 sessions of 15 min)
Intervention Type
Behavioral
Intervention Name(s)
Working memory training
Intervention Description
Working memory training on a tactile tablet for a month (20 sessions of 15 min)
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness training
Intervention Description
Mindfulness training on a tactile tablet for a month (20 sessions of 15 min)
Intervention Type
Behavioral
Intervention Name(s)
Active control training
Intervention Description
Active control training on a tactile tablet for a month (20 sessions of 15 min)
Intervention Type
Genetic
Intervention Name(s)
Saliva collection
Intervention Description
Collection of a saliva sample for genotyping
Intervention Type
Procedure
Intervention Name(s)
Brain Magnetic Resonance Imaging
Intervention Description
Structural and functional MRI
Intervention Type
Behavioral
Intervention Name(s)
Cognitive testing
Intervention Description
Battery of cognitive and academic tasks on executive functions
Primary Outcome Measure Information:
Title
Change in brain functional BOLD activity after one month of executive training as assessed by MRI in regions subtending executive functioning.
Description
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)
Title
Change in brain cortical structure after one month of executive training as assessed by anatomical MRI in regions subtending executive functioning.
Description
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)
Title
Change in cognitive behavioral measures after one month of executive training as assessed by cognitive testing
Description
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)
Secondary Outcome Measure Information:
Title
Sulcal morphometry measured by anatomical MRI
Description
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)
Title
Genetic variations measured by Single Nucleotide Polymorphism (SNP) genotyping
Description
Assessing the impact of the different genotypes on behavioral and brain changes associated to a one-month executive training.
Time Frame
Pretest (t0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bernard Guillois, Professor
Phone
02.31.25.27.64
Ext
+33
Email
guillois-b@chu-caen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier Houdé, Professor
Phone
01.40.46.29.95
Ext
+33
Email
olivier.houde@parisdescartes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Houdé, Professor
Organizational Affiliation
University of Paris 5 - Rene Descartes
Official's Role
Principal Investigator
Facility Information:
Facility Name
GIP Cyceron
City
Caen
ZIP/Postal Code
14074
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Houdé, Professor
Phone
01.40.46.29.95
Ext
+33
Email
olivier.houde@parisdescartes.fr
First Name & Middle Initial & Last Name & Degree
Grégoire Borst, Professor
Phone
01.40.46.30.04
Ext
+33
Email
gregoire.borst@parisdescartes.fr
First Name & Middle Initial & Last Name & Degree
François Orliac, MD
First Name & Middle Initial & Last Name & Degree
Valérie Datin-Dorrière, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Executive Training and Brain in Children

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