Executive Training and Brain in Children (APEX)

December 7, 2016 updated by: University Hospital, Caen

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14074
        • Recruiting
        • GIP Cyceron
        • Contact:
        • Contact:
        • Sub-Investigator:
          • François Orliac, MD
        • Sub-Investigator:
          • Valérie Datin-Dorrière, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 10 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Preterm Inhibition

In children born very preterm:

Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Behavioral: Inhibition training
Inhibition 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
EXPERIMENTAL: Full-term Inhibition

In children born full-term:

Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
Behavioral: Inhibition training
Inhibition 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
EXPERIMENTAL: Full-term Working memory

In children born full-term:

Working memory training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
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
Behavioral: Working memory training
Working memory training on a tactile tablet for a month (20 sessions of 15 min)
EXPERIMENTAL: Full-term Mindfulness

In children born full-term:

Mindfulness training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
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
Behavioral: Mindfulness training
Mindfulness training on a tactile tablet for a month (20 sessions of 15 min)
ACTIVE_COMPARATOR: Full-term Active control

In children born full-term:

Active control training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
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
Behavioral: Active control training
Active control training on a tactile tablet for a month (20 sessions of 15 min)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months)
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.
Time Frame: 3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months)

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
Time Frame: 3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months)

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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sulcal morphometry measured by anatomical MRI
Time Frame: Pretest (t0)
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
Time Frame: Pretest (t0)
Assessing the impact of the different genotypes on behavioral and brain changes associated to a one-month executive training.
Pretest (t0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Collaborators

National Research Agency, France

Investigators

  • Principal Investigator: Olivier Houdé, Professor, University of Paris 5 - Rene Descartes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ANTICIPATED)

October 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

May 27, 2016

First Submitted That Met QC Criteria

December 7, 2016

First Posted (ESTIMATE)

December 12, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 12, 2016

Last Update Submitted That Met QC Criteria

December 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A00383-46
  • 15-045 (OTHER: University Hospital, Caen)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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