Domain-general and Domain-specific Contributions to the D... | NCT06658392

Studies
Domain-general and Domain-specific Contributions to the Development of Numerical Cognition

NCT06658392

Sponsor

Centre Hospitalier St Anne

Status

Completed

Last Update Posted

Oct 26, 2024Actual

Enrollment

58Actual

Phase

Not Applicable

Conditions

No Condition

Interventions

cognitive tasks

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2021Actual

Primary Completion Date

Sep 27, 2024Actual

Completion Date

Sep 27, 2024Actual

First Submitted Date

Oct 3, 2024

First Submission Date that Met QC Criteria

Oct 23, 2024

First Posted Date

Oct 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2024

Last Update Posted Date

Oct 26, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Using T2*-weighted eip imaging, we measured BOLD response in two cohorts of healthy children while they were doing different cognitive tasks in the scanner. These tasks included solving non-symbolic (i.e. sets of elements) and symbolic (i.e. Arabic digits) addition and subtraction problems, a color control task, an attentional task measuring different facets of spatial attention, and a task measuring inhibition. We also recorded a high-resolution anatomical scan of the brain.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
arithmetic	Experimental	exploring neurocognitive mechanisms underlying development of arithmetic competencies in healthy children.	Other: cognitive tasks

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cognitive tasks	Other	no intervention in a medical sense, only observing changes of BOLD signal during different experimental conditions in cognitive tasks (arithmetic, attention, inhibition)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

7 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided