Executive Training and Brain in Adolescent

NCT ID: NCT03084848

Last Updated: 2019-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-18
• Study Completion Date: 2017-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Active control

Group Type: EXPERIMENTAL

Training

Intervention Type: OTHER

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

Inhibitor control

Group Type: EXPERIMENTAL

Training

Intervention Type: OTHER

25 training sessions of 15 minutes per day, 5 days a week for a month of inhibitory control

Interventions

Training

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

Intervention Type: OTHER

Training

25 training sessions of 15 minutes per day, 5 days a week for a month of inhibitory control

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role: collaborator

Centre Hospitalier St Anne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine OPPENHEIM

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Sainte-Anne

Arnaud Cachia, PhD, Pr

Role: STUDY_DIRECTOR

University Paris Descartes

Locations

Centre de Recherche Clinique (CRC) - CHSA

Paris, , France

Centre Hospitalier Sainte-Anne

Paris, , France

Countries

France

References

Ahr E, Houde O, Borst G. Inhibition of the mirror generalization process in reading in school-aged children. J Exp Child Psychol. 2016 May;145:157-65. doi: 10.1016/j.jecp.2015.12.009. Epub 2016 Jan 27.

Reference Type: BACKGROUND

PMID: 26827098 (View on PubMed)

Cachia A, Borst G, Vidal J, Fischer C, Pineau A, Mangin JF, Houde O. The shape of the ACC contributes to cognitive control efficiency in preschoolers. J Cogn Neurosci. 2014 Jan;26(1):96-106. doi: 10.1162/jocn_a_00459. Epub 2013 Aug 5.

Reference Type: BACKGROUND

PMID: 23915057 (View on PubMed)

Borst G, Cachia A, Vidal J, Simon G, Fischer C, Pineau A, Poirel N, Mangin JF, Houde O. Folding of the anterior cingulate cortex partially explains inhibitory control during childhood: a longitudinal study. Dev Cogn Neurosci. 2014 Jul;9:126-35. doi: 10.1016/j.dcn.2014.02.006. Epub 2014 Feb 27.

Reference Type: BACKGROUND

PMID: 24642370 (View on PubMed)

Other Identifiers

2015-A00811-48

Identifier Type: OTHER

Identifier Source: secondary_id

D15-P017

Identifier Type: -

Identifier Source: org_study_id