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Clinical Trials/NCT03084848
NCT03084848CompletedNot Applicable

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

Centre Hospitalier St Anne4 sites in 1 country60 target enrollmentStarted: May 18, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
4
Primary Endpoint
Brain plasticity : Longitudinal cortical thickness change

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
16 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Brain plasticity : Longitudinal cortical thickness change

Time Frame: one month IC training

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Centre Hospitalier St Anne
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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