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Completed

NCT Number: NCT03084848

Executive Training and Brain in Adolescent

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

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Key information

Age range

16 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Sainte-Anne, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training

Other

25 training sessions of 15 minutes per day, 5 days a week for a month of crystallised intelligence

Primary outcomes

  1. Brain plasticity : Longitudinal cortical thickness change

    Time frame: Baseline

  2. Brain plasticity : Longitudinal cortical thickness change

    Time frame: one month IC training

Sponsors and collaborators

Lead sponsor

Centre Hospitalier St Anne

Other

Collaborators

  • Centre National de la Recherche Scientifique, France

Registry information

Official study title

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

Acronym: APEX-ADO

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 21, 2017
Registry last updated
Jul 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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