- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06658392
Domain-general and Domain-specific Contributions to the Development of Numerical Cognition (CFDDCN)
October 23, 2024 updated by: Centre Hospitalier St Anne
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France, 75014
- Centre Hospitalier Sainte-Anne
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: arithmetic
exploring neurocognitive mechanisms underlying development of arithmetic competencies in healthy children.
|
no intervention in a medical sense, only observing changes of BOLD signal during different experimental conditions in cognitive tasks (arithmetic, attention, inhibition)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BOLD response
Time Frame: BOLD response recorded during fMRI session
|
changes of BOLD response under different experimental conditions (non-symbolic arithmetic; symbolic arithmetic; inhibition; attention)
|
BOLD response recorded during fMRI session
|
|
BOLD response
Time Frame: during fMRI session
|
changes of BOLD response in experimental conditions
|
during fMRI session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Catherine OPPENHEIM, Pr, Promotor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 30, 2021
Primary Completion (Actual)
September 27, 2024
Study Completion (Actual)
September 27, 2024
Study Registration Dates
First Submitted
October 3, 2024
First Submitted That Met QC Criteria
October 23, 2024
First Posted (Actual)
October 26, 2024
Study Record Updates
Last Update Posted (Actual)
October 26, 2024
Last Update Submitted That Met QC Criteria
October 23, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- D20-P011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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