NCT02763657

Brief Summary

Children's understanding of linear-order (e.g., Dan is taller than Lisa, Lisa is taller than Jess) and set-inclusion (i.e., All tulips are flowers, All flowers are plants) relationships is critical for the acquisition of deductive reasoning, that is, the ability to reach logically valid conclusions from given premises. Behavioral and neuroimaging studies in adults suggest processing differences between these relations: While arguments that involve linear-orders may be preferentially associated with spatial processing, arguments that involve set-inclusions may be preferentially associated with verbal processing. In this study, we use functional magnetic resonance imaging to investigate how and when these processing differences appear in children from 8 to 14.

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
60

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Oct 2013

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

October 1, 2013

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 5, 2016

Status Verified

May 1, 2016

Enrollment Period

3.2 years

First QC Date

May 3, 2016

Last Update Submit

May 3, 2016

Conditions

Keywords

fMRIreasoningdevelopment

Outcome Measures

Primary Outcomes (1)

  • Identification of brain regions engaged in linear-order and set-inclusion reasoning

    Brain activity measured using fMRI

    30 days

Secondary Outcomes (1)

  • Degree of overlap between brain regions involved in linear-order and set-inclusion reasoning

    30 days

Study Arms (1)

Brain activity during reasoning

EXPERIMENTAL
Other: fMRI scanning

Interventions

All participants are scanned while evaluating linear-order and set-inclusion reasoning problems

Brain activity during reasoning

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Right-handed
  • Affiliated to the French social security
  • Whose parents gave informed consent

You may not qualify if:

  • Neurological disorders
  • Psychiatric disorders
  • Birth complications requiring admission into neonatal intensive care unit
  • Medication affecting central nervous system processing
  • Significant hearing impairment
  • Uncorrected visual impairment
  • Non-native English speaker
  • Contraindications for MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon/bron, 69500, France

RECRUITING

Central Study Contacts

Christian SCHEIBER, Pr, MD

CONTACT

Justine EPINAT, CRA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 5, 2016

Study Start

October 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 5, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations