NCT03084848

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started May 2016

Typical duration for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 18, 2016

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 2, 2019

Status Verified

June 1, 2019

Enrollment Period

1.5 years

First QC Date

April 6, 2016

Last Update Submit

June 28, 2019

Conditions

Healthy

Keywords

brain/cognitive measuresconditioninhibitor controltraining at adolescence

Outcome Measures

Primary Outcomes (2)

  • Brain plasticity : Longitudinal cortical thickness change

    Baseline

  • Brain plasticity : Longitudinal cortical thickness change

    one month IC training

Study Arms (2)

Active control

EXPERIMENTAL
Other: Training

Inhibitor control

EXPERIMENTAL
Other: Training

Interventions

TrainingOTHER

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

Active control

Eligibility Criteria

Age16 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre de Recherche Clinique (CRC) - CHSA

Paris, 75014, France

Location

Centre Hospitalier Sainte-Anne

Paris, 75014, France

Location

Related Publications (3)

  • 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.

    PMID: 26827098BACKGROUND

  • 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.

    PMID: 23915057BACKGROUND

  • 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.

    PMID: 24642370BACKGROUND

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Catherine OPPENHEIM

    Centre Hospitalier Sainte-Anne

    PRINCIPAL INVESTIGATOR

  • Arnaud Cachia, PhD, Pr

    University Paris Descartes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2016

First Posted

March 21, 2017

Study Start

May 18, 2016

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

July 2, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)