NCT06658392

Brief Summary

Exploring the non-symbolic and symbolic arithmetic competencies in two groups of children (5-, and 7-year-olds). Additionally, we explored the relationship with domain-general factors such as inhibition and attention. Recorded fMRI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 30, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
Last Updated

October 26, 2024

Status Verified

September 1, 2024

Enrollment Period

3.5 years

First QC Date

October 3, 2024

Last Update Submit

October 23, 2024

Conditions

Keywords

cognitive neurosciencenumerical cognition

Outcome Measures

Primary Outcomes (2)

  • BOLD response

    changes of BOLD response under different experimental conditions (non-symbolic arithmetic; symbolic arithmetic; inhibition; attention)

    BOLD response recorded during fMRI session

  • BOLD response

    changes of BOLD response in experimental conditions

    during fMRI session

Study Arms (1)

arithmetic

EXPERIMENTAL

exploring neurocognitive mechanisms underlying development of arithmetic competencies in healthy children.

Other: cognitive tasks

Interventions

no intervention in a medical sense, only observing changes of BOLD signal during different experimental conditions in cognitive tasks (arithmetic, attention, inhibition)

arithmetic

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • school enrollment
  • French as mother tongue
  • right-handed
  • normal medical, neurological and neuroradiological examinations - parents affiliated to a social security scheme

You may not qualify if:

  • not within age range
  • monocygotic twins
  • \- contraindications to an MRI examination (neurosensory stimulator or implantable defibrillator, cochlear implants, ferromagnetic ocular or cerebral foreign bodies close to nerve structures, metal prostheses, patient agitation: uncooperative or agitated patients, claustrophobic subjects, ventriculoperitoneal neurosurgical shunt valves, dental apparatus, etc.).
  • sudden onset of cognitive problems that could indicate a stroke; a history of head trauma with loss of consciousness lasting more than 1 hour, or encephalitis; - a chronic neurological, psychiatric, endocrine, hepatic or infectious condition
  • a history of major illness (diabetes, chronic lung disease, severe cardiac, metabolic, hematological, endocrinological or immunological disorders, cancer); - medication likely to interfere with brain imaging measurements
  • color blindness or uncorrected visual disorders
  • inability to take part in the study for geographical or psychiatric reasons
  • presence of pervasive developmental and/or acquisition disorders identified by parents or legal guardians and/or teachers
  • cerebral palsy
  • impaired fine motor skills
  • parents or legal guardians not affiliated to a social security scheme
  • unaccompanied by parent(s) or legal guardian(s) during visits.
  • tattoo not compatible with MRI
  • children and parents under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sainte-Anne

Paris, 75014, France

Location

Study Officials

  • Catherine OPPENHEIM, Pr

    Promotor

    PRINCIPAL INVESTIGATOR

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

October 3, 2024

First Posted

October 26, 2024

Study Start

March 30, 2021

Primary Completion

September 27, 2024

Study Completion

September 27, 2024

Last Updated

October 26, 2024

Record last verified: 2024-09

Locations