NCT02989116

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 12, 2016

Status Verified

November 1, 2016

Enrollment Period

4 years

First QC Date

May 27, 2016

Last Update Submit

December 7, 2016

Conditions

Healthy ChildrenPreterm Birth

Keywords

LearningExecutive functionsCognitive controlPrefrontal CortexTypically developing childrenGenotypeFunctional Magnetic Resonance ImagingStructural Magnetic Resonance ImagingInhibitionWorking MemoryMetacognitionMindfulnessPreterm childrenDevelopmental PsychologyDevelopmental cognitive neuroscienceTouch screen tabletAdaptive training

Outcome Measures

Primary Outcomes (3)

  • 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)

Secondary Outcomes (2)

  • Sulcal morphometry measured by anatomical MRI

    Pretest (t0)

  • Genetic variations measured by Single Nucleotide Polymorphism (SNP) genotyping

    Pretest (t0)

Study Arms (5)

Preterm Inhibition

EXPERIMENTAL

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

Behavioral: Inhibition trainingGenetic: Saliva collectionProcedure: Brain Magnetic Resonance ImagingBehavioral: Cognitive testing

Full-term Inhibition

EXPERIMENTAL

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

Behavioral: Inhibition trainingGenetic: Saliva collectionProcedure: Brain Magnetic Resonance ImagingBehavioral: Cognitive testing

Full-term Working memory

EXPERIMENTAL

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

Behavioral: Working memory trainingGenetic: Saliva collectionProcedure: Brain Magnetic Resonance ImagingBehavioral: Cognitive testing

Full-term Mindfulness

EXPERIMENTAL

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

Behavioral: Mindfulness trainingGenetic: Saliva collectionProcedure: Brain Magnetic Resonance ImagingBehavioral: Cognitive testing

Full-term Active control

ACTIVE COMPARATOR

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

Behavioral: Active control trainingGenetic: Saliva collectionProcedure: Brain Magnetic Resonance ImagingBehavioral: Cognitive testing

Interventions

Inhibition trainingBEHAVIORAL

Inhibition training on a tactile tablet for a month (20 sessions of 15 min)

Full-term InhibitionPreterm Inhibition
Working memory trainingBEHAVIORAL

Working memory training on a tactile tablet for a month (20 sessions of 15 min)

Full-term Working memory
Mindfulness trainingBEHAVIORAL

Mindfulness training on a tactile tablet for a month (20 sessions of 15 min)

Full-term Mindfulness
Active control trainingBEHAVIORAL

Active control training on a tactile tablet for a month (20 sessions of 15 min)

Full-term Active control
Saliva collectionGENETIC

Collection of a saliva sample for genotyping

Full-term Active controlFull-term InhibitionFull-term MindfulnessFull-term Working memoryPreterm Inhibition
Brain Magnetic Resonance ImagingPROCEDURE

Structural and functional MRI

Full-term Active controlFull-term InhibitionFull-term MindfulnessFull-term Working memoryPreterm Inhibition
Cognitive testingBEHAVIORAL

Battery of cognitive and academic tasks on executive functions

Full-term Active controlFull-term InhibitionFull-term MindfulnessFull-term Working memoryPreterm Inhibition

Eligibility Criteria

Age9 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Male or female
  • 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
  • \- Full term pregnancy with no abnormal event (\>= 37 weeks of amenorrhea)
  • \- Delivery before 33 weeks of amenorrhea

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GIP Cyceron

Caen, 14074, France

RECRUITING

MeSH Terms

Conditions

Premature BirthInhibition, Psychological

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBehavior

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Olivier Houdé, Professor

    University of Paris 5 - Rene Descartes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernard Guillois, Professor

CONTACT

02.31.25.27.64guillois-b@chu-caen.fr

Olivier Houdé, Professor

CONTACT

01.40.46.29.95olivier.houde@parisdescartes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2016

First Posted

December 12, 2016

Study Start

October 1, 2015

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

December 12, 2016

Record last verified: 2016-11

Locations

FR(1)