Healthy VolunteersNEUREASNCT02763657
Neural Development of Deductive Reasoning
A study testing fMRI scanning in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- fMRI scanning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Dec 2016
- 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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Right-handed
- Affiliated to the French social security
- Whose parents gave informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Lyon/bron, 69500
Juistine EPINAT, CRA, 4 37 91 12 64 ext. +33, jepinat@isc.cnrs.fr
About this study
Official title: Neural Development of Deductive Reasoning: an fMRI Study of Relational and Categorical Reasoning in Children
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.
- Conditions
- Healthy Volunteers
- Being tested
- fMRI scanning
- Keywords
- fMRI, reasoning, development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI scanningOther
All participants are scanned while evaluating linear-order and set-inclusion reasoning problems
| Study group | Role | What they receive |
|---|---|---|
| Brain activity during reasoning | Experimental | Not described Receives: Other: fMRI scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of brain regions engaged in linear-order and set-inclusion reasoning
Brain activity measured using fMRI
Measured: 30 days
Secondary outcomes (1)
Degree of overlap between brain regions involved in linear-order and set-inclusion reasoning
Degree of overlap in brain activity measured using fMRI
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startOct 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763657
- Sponsor's protocol ID
- 2012.767
- Acronym
- NEUREAS
- Status last verified
- May 2016
- First submitted
- 3 May 2016
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Development of Deductive Reasoning: an fMRI Study of Relational and Categorical Reasoning in Children
- ClinicalTrials.gov ID
- NCT02763657
- Acronym / sponsor ID
- NEUREAS / 2012.767
- Conditions
- Healthy Volunteers
- Keywords
- fMRI, reasoning, development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 5 May 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain activity during reasoning | Experimental | Other: fMRI scanning |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Right-handed
- Affiliated to the French social security
- Whose parents gave informed consent
Key exclusion criteria (8 listed)
- Neurological disorders
- Psychiatric disorders
- Birth complications requiring admission into neonatal intensive care unit
- Medication affecting central nervous system processing
- Significant hearing impairment
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 |
|---|---|---|
| fMRI scanningAll participants are scanned while evaluating linear-order and set-inclusion reasoning problems | Other | Brain activity during reasoning |
Primary outcome
Identification of brain regions engaged in linear-order and set-inclusion reasoning
Time frame: 30 days
Brain activity measured using fMRI
1 secondary outcome
Degree of overlap between brain regions involved in linear-order and set-inclusion reasoning
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI scanning in people with Healthy Volunteers, run by Hospices Civils de Lyon 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 5 May 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian SCHEIBER, Pr, MD (4 72 68 49 61 ext. +33, christian.scheiber@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of brain regions engaged in linear-order and set-inclusion reasoning (time frame: 30 days). 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 5 May 2016.