Executive Training and Brain in Adolescent (APEX-ADO)

June 28, 2019 updated by: Centre Hospitalier St Anne

Cerebral Bases of the Cognitive Learning in the Executive Control In the Adolescence

The purpose of this study is to investigate the cognitive and brain effects of inhibitory control (IC) training at adolescence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Brain imaging now allows to study non-invasively cognitive learning processes. An area of strong scientific interest is the development of executive control, an essential cognitive domain for academic and professional success and for mental and physical health. These functions are essentially located within the prefrontal cortex, characterising by a late maturation until the end of adolescence and, while under genetic control, can likely be improved with targeted interventions. The objective of this project is simple and innovative: testing in adolescents with the most appropriate brain imaging technologies available today (the Magnetic Resonance Imaging, MRI), the effect of an executive training focused on the inhibitory control (IC). This project aims at precisely testing the effect at the cognitive and brain levels of IC training in adolescence. To do this, the investigators will recruit two groups of 30 teenagers aged 16 to 17 years old, each assigned to one of two learning situations: IC vs Active Control (AC). Each participant will participate in 25 training sessions of 15 minutes per day, 5 days a week for a month. Brain structural and functional differences in the brain and between the pre-test and post-test related to intense IC training will be correlated with cognitive progress.

Study Type

Interventional

Enrollment (Actual)

60

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
      • Paris, France, 75014
        • Centre Hospitalier Sainte-Anne
      • Paris, France, 75014
        • Centre de Recherche Clinique (CRC) - CHSA

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

16 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 16-17 years old
  • girl or boy ;
  • French mother tongue;
  • Handedness: Right;
  • Schooled in a level corresponding to its age (2nd or 1st)
  • Informed consent signed by the (s) holder (s) of parental authority, in agreement with the teenager
  • Normal medical, neurological, neuroradiological examinations.
  • Health insurance

Exclusion Criteria:

  • classical exclusion criteria for MRI
  • Has chronic use of alcohol or drugs;
  • Abuse or substance dependence (excluding nicotine) or a toxic over 5 years or has led to comas (overdoses)
  • Cognitive disorders of sudden onset that may reflect a stroke; history of head trauma with loss of consciousness for more than 1 hour, or encephalitis;
  • A chronic neurological disorder, psychiatric, endocrine, hepatic and infectious disorder;
  • Major disease history (diabetes, chronic lung disease, heart disorder, metabolic, hematologic, endocrine or immunological severe cancer);
  • A medication that may interfere with brain imaging measures (psychotropic drugs, hypnotics, anxiolytics, antipsychotics, anti-Parkinson, benzodiazepines, anti-inflammatory drugs, antiepileptics, antihistamines, analgesics and muscle relaxants central);
  • dyschromatopsia
  • Impossibility to submit itself to the study for geographical or psychiatric reasons;
  • Pregnant and lactating women;
  • Has pervasive developmental disorders and / or acquisitions identified by parents or legal guardian and (or) the teachers;
  • Cerebral palsy;
  • Fine motor disorder
  • Unaccompanied by parent (s) (s) or at least a person with parental authority during the visit to the research platform;
  • Tattoo on the head, neck or shoulders

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active control
Other: Training
25 training sessions of 15 minutes per day, 5 days a week for a month of crystallised intelligence
Other: Training
25 training sessions of 15 minutes per day, 5 days a week for a month of inhibitory control
Experimental: Inhibitor control
Other: Training
25 training sessions of 15 minutes per day, 5 days a week for a month of crystallised intelligence
Other: Training
25 training sessions of 15 minutes per day, 5 days a week for a month of inhibitory control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brain plasticity : Longitudinal cortical thickness change
Time Frame: Baseline
Baseline
Brain plasticity : Longitudinal cortical thickness change
Time Frame: one month IC training
one month IC training

Collaborators and Investigators

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

Sponsor

Centre Hospitalier St Anne

Collaborators

Centre National de la Recherche Scientifique, France

Investigators

  • Principal Investigator: Catherine OPPENHEIM, Centre Hospitalier Sainte-Anne
  • Study Director: Arnaud Cachia, PhD, Pr, University Paris Descartes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

May 18, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

April 6, 2016

First Submitted That Met QC Criteria

March 14, 2017

First Posted (Actual)

March 21, 2017

Study Record Updates

Last Update Posted (Actual)

July 2, 2019

Last Update Submitted That Met QC Criteria

June 28, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D15-P017
  • 2015-A00811-48 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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