No ConditionCFDDCNNCT06658392
Domain-general and Domain-specific Contributions to the Development of Numerical Cognition
A study testing cognitive tasks in people with No Condition, run by Centre Hospitalier St Anne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- No Condition
- What is being tested?
- cognitive tasks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2021to 27 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- school enrollment
- French as mother tongue
- right-handed
- normal medical, neurological and neuroradiological examinations - parents affiliated to a social security scheme
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- No Condition
- Being tested
- cognitive tasks
- Keywords
- cognitive neuroscience, numerical cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive tasksOther
no intervention in a medical sense, only observing changes of BOLD signal during different experimental conditions in cognitive tasks (arithmetic, attention, inhibition)
| Study group | Role | What they receive |
|---|---|---|
| arithmetic | Experimental | exploring neurocognitive mechanisms underlying development of arithmetic competencies in healthy children. Receives: Other: cognitive tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD response
changes of BOLD response under different experimental conditions (non-symbolic arithmetic; symbolic arithmetic; inhibition; attention)
Measured: BOLD response recorded during fMRI session
BOLD response
changes of BOLD response in experimental conditions
Measured: during fMRI session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start30 Mar 2021
- Primary completion27 Sep 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No ConditionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine OPPENHEIM, Pr, Principal investigator, Promotor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658392
- Sponsor's protocol ID
- D20-P011
- Acronym
- CFDDCN
- Status last verified
- Sep 2024
- First submitted
- 3 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Domain-general and Domain-specific Contributions to the Development of Numerical Cognition
- ClinicalTrials.gov ID
- NCT06658392
- Acronym / sponsor ID
- CFDDCN / D20-P011
- Conditions
- No Condition
- Keywords
- cognitive neuroscience, numerical cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| arithmetic | Experimental | Other: cognitive tasksexploring neurocognitive mechanisms underlying development of arithmetic competencies in healthy children. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- school enrollment
- French as mother tongue
- right-handed
- normal medical, neurological and neuroradiological examinations - parents affiliated to a social security scheme
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive tasksno intervention in a medical sense, only observing changes of BOLD signal during different experimental conditions in cognitive tasks (arithmetic, attention, inhibition) | Other | arithmetic |
Primary outcome
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
Time frame: during fMRI session
changes of BOLD response in experimental conditions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine OPPENHEIM, Pr principal investigator
Promotor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive tasks in people with No Condition, run by Centre Hospitalier St Anne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD response (time frame: BOLD response recorded during fMRI session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.