NCT02788968

Brief Summary

The study to explore the development of these abilities with age, and called "Development of the conflict detection during the reasoning - Decor" will take place at CYCERON center and will include two groups of 22 participants: adolescents and young adults (N = 44). More specifically, this study aims to compare the changes in the brain of adolescents and young adults when conducting reasoning tasks for which there may be a cognitive conflict. Both groups of participants then spend an MRI (Magnetic Resonance Imaging) focused on the brain and in which they will carry out two classic tasks covering the main areas of reasoning (probabilistic and economic). Each of these tasks will be manipulated to include, or not, of making information call intuition to create or not a conflict between the correct answer (logic, normative) and biased response (intuitive, heuristic). Because of the major implication of this brain region in cognitive inhibition processes \[of intuitive answer\], measured brain activity in the anterior cingulate cortex (ACC) during both tasks version "with" or "no" conflict will be compared between groups. To better understand the links between the development of the CCA from adolescence to adulthood and conflict detection, activity measurements will be correlated with a part in morphometric measurements taken from the same area (volume Substance Grise - SG; characteristics of cortical sulci) and secondly to cognitive measures (executive functions - inhibitory control). This cross-sectional study focused on two age groups: 11-15 years and 19-25 years. For each age group, the participation of men / boys and women / girls will be balanced up.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

June 2, 2016

Status Verified

May 1, 2016

Enrollment Period

2.1 years

First QC Date

February 9, 2016

Last Update Submit

June 1, 2016

Conditions

Keywords

Psychology and Cognitive Neuroscience of developmentAdolescent and young adult healthy volunteersAnatomical and functionally Magnetic Resonance Imaging (MRI)Conflict detectionReasoning

Outcome Measures

Primary Outcomes (1)

  • brain activity in the anterior cingulate cortex (ACC )

    measured brain activity in the anterior cingulate cortex (ACC ) of healthy volunteers aged 11 to 15 participants , and from 19 to 25 years over two classic version reasoning tasks "with" and "without" cognitive conflict and realized on an MRI

    Day 1

Secondary Outcomes (3)

  • the activity recorded in the whole brain

    Day 1

  • response time

    Day 1

  • brain activity measured in the CSF in two classic reasoning tasks

    Day 1

Study Arms (2)

Adolescents

OTHER

MRI 11-15 years

Other: MRI

Young adults

EXPERIMENTAL

MRI 19-25 years

Other: MRI

Interventions

MRIOTHER

Conventional reasoning tasks in both " with" and "without" cognitive conflict and realized during an MRI

AdolescentsYoung adults

Eligibility Criteria

Age11 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy and educated adolescents aged 11-15 years
  • boy or girl
  • French mother tongue
  • Handedness : right
  • Having been informed by the teen booklet and given its written consent, and whose parents or legal guardian will be ( a) signed the informed consent sheet of the protocol
  • Medical examinations , neurological, neuroradiological norma
  • All healthy young adults aged 19-25 years at university level or in the workforce
  • man or woman
  • Level ≥ 12 years of study (bachelor level )
  • Native language: French
  • Handedness : right
  • Signing of the informed consent of the protocol
  • Medical examinations , neurological, neuroradiological norma

You may not qualify if:

  • Does not meet the targeted age groups
  • Presents against -indications to MRI (severe claustrophobia , foreign bodies cons -indicated )
  • This chronic intake of alcohol or drugs
  • Cognitive disorders who could testify sudden onset of a stroke ; a history of head injury with loss of consciousness for more than 1 hour , or encephalitis
  • A neurological chronic condition , psychiatric, endocrine , hepatic and infectious
  • 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 ( psychotropics, hypnotics, anxiolytics , neuroleptics, anti -Parkinson , benzodiazepines, anti-inflammatory drugs , antiepileptics, antihistamines , analgesics and muscle relaxants central ) .
  • Manual predominantly left (after the first phone call with the contact person of CYCERON ; see section 9.1)
  • Color Blindness
  • Inability to submit the study for geographical or psychiatric reasons
  • Pregnant and lactating women
  • The following criteria are specific to the adolescent group :
  • Has pervasive developmental disorders and / or acquisitions identified by parents or legal guardian and (or ) the teachers
  • Parents or legal guardian are not affiliated to a system of social security
  • Unaccompanied by parent (s) (s) or legal guardian during the visit to CYCERON center
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Caen

Caen, 14000, France

RECRUITING

Study Officials

  • Wym WN De Nyes, PhD

    Cyceron

    STUDY DIRECTOR

Central Study Contacts

Olivier EO Etard, MCU-PH

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 9, 2016

First Posted

June 2, 2016

Study Start

September 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2017

Last Updated

June 2, 2016

Record last verified: 2016-05

Locations