Executive Training and Brain in Adolescent

Healthy Clinical Trial

— APEX-ADO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03084848
• Other study ID #: D15-P017
• Secondary ID: 2015-A00811-48
• Status: Completed
• Phase: N/A
• Start date: May 18, 2016
• Est. completion date: December 2017

Study information

• Verified date: June 2019
• Source: Centre Hospitalier St Anne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Training
25 training sessions of 15 minutes per day, 5 days a week for a month of crystallised intelligence
• Training
25 training sessions of 15 minutes per day, 5 days a week for a month of inhibitory control

Locations

Country	Name	City	State
France	Centre de Recherche Clinique (CRC) - CHSA	Paris
France	Centre Hospitalier Sainte-Anne	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier St Anne	Centre National de la Recherche Scientifique, France

Country where clinical trial is conducted

France, 

References & Publications (3)

Ahr E, Houdé 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. — View Citation

Borst G, Cachia A, Vidal J, Simon G, Fischer C, Pineau A, Poirel N, Mangin JF, Houdé 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. — View Citation

Cachia A, Borst G, Vidal J, Fischer C, Pineau A, Mangin JF, Houdé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain plasticity : Longitudinal cortical thickness change		Baseline
Primary	Brain plasticity : Longitudinal cortical thickness change		one month IC training