Healthy VolunteersDéCoRNCT02788968
Conflict Detection Development During the Reasoning
A study testing MRI in people with Healthy Volunteers, run by University Hospital, Caen at 1 site in France.
Trial summary
The study to explore the development of these abilities with age, and called "Development of the conflict detection during the reasoning - Decor" will take place at CYCERON center and will include two groups of 22 participants: adolescents and young adults (N = 44). Read more about this study
- Who is it for?
- Ages 11 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Oct 2017
- 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 11 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy and educated adolescents aged 11-15 years
- boy or girl
- French mother tongue
- Handedness : right
- Having been informed by the teen booklet and given its written consent, and whose parents or legal guardian will be ( a) signed the informed consent sheet of the protocol
- Medical examinations , neurological, neuroradiological norma
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- or
- All healthy young adults aged 19-25 years at university level or in the workforce
- man or woman
- Level ≥ 12 years of study (bachelor level )
- Native language: French
- Handedness : right
- Signing of the informed consent of the protocol
- Medical examinations , neurological, neuroradiological norma
Who cannot join
- Does not meet the targeted age groups
- Presents against -indications to MRI (severe claustrophobia , foreign bodies cons -indicated )
- This chronic intake of alcohol or drugs
- Cognitive disorders who could testify sudden onset of a stroke ; a history of head injury with loss of consciousness for more than 1 hour , or encephalitis
- A neurological chronic condition , psychiatric, endocrine , hepatic and infectious
- Major disease history (diabetes, chronic lung disease, heart disorder, metabolic , hematologic , endocrine or immunological severe, cancer)
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- A medication that may interfere with brain imaging measures ( psychotropics, hypnotics, anxiolytics , neuroleptics, anti -Parkinson , benzodiazepines, anti-inflammatory drugs , antiepileptics, antihistamines , analgesics and muscle relaxants central ) .
- Manual predominantly left (after the first phone call with the contact person of CYCERON ; see section 9.1)
- Color Blindness
- Inability to submit the study for geographical or psychiatric reasons
- Pregnant and lactating women
- The following criteria are specific to the adolescent group :
- Has pervasive developmental disorders and / or acquisitions identified by parents or legal guardian and (or ) the teachers
- Parents or legal guardian are not affiliated to a system of social security
- Unaccompanied by parent (s) (s) or legal guardian during the visit to CYCERON center
- The following criteria are specific to the group of young adults :
- Non- affiliated to a social security scheme
- Be protected adult
Trial locations and contacts
1 site in 1 country.
About this study
The study to explore the development of these abilities with age, and called "Development of the conflict detection during the reasoning - Decor" will take place at CYCERON center and will include two groups of 22 participants: adolescents and young adults (N = 44). More specifically, this study aims to compare the changes in the brain of adolescents and young adults when conducting reasoning tasks for which there may be a cognitive conflict. Both groups of participants then spend an MRI (Magnetic Resonance Imaging) focused on the brain and in which they will carry out two classic tasks covering the main areas of reasoning (probabilistic and economic). Each of these tasks will be manipulated to include, or not, of making information call intuition to create or not a conflict between the correct answer (logic, normative) and biased response (intuitive, heuristic). Because of the major implication of this brain region in cognitive inhibition processes [of intuitive answer], measured brain activity in the anterior cingulate cortex (ACC) during both tasks version "with" or "no" conflict will be compared between groups. To better understand the links between the development of the CCA from adolescence to adulthood and conflict detection, activity measurements will be correlated with a part in morphometric measurements taken from the same area (volume Substance Grise - SG; characteristics of cortical sulci) and secondly to cognitive measures (executive functions - inhibitory control). This cross-sectional study focused on two age groups: 11-15 years and 19-25 years. For each age group, the participation of men / boys and women / girls will be balanced up.
- Conditions
- Healthy Volunteers
- Being tested
- MRI
- Keywords
- Psychology and Cognitive Neuroscience of development, Adolescent and young adult healthy volunteers, Anatomical and functionally Magnetic Resonance Imaging (MRI), Conflict detection, Reasoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Conventional reasoning tasks in both " with" and "without" cognitive conflict and realized during an MRI
| Study group | Role | What they receive |
|---|---|---|
| Adolescents | Other | MRI 11-15 years Receives: Other: MRI |
| Young adults | Experimental | MRI 19-25 years Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain activity in the anterior cingulate cortex (ACC )
measured brain activity in the anterior cingulate cortex (ACC ) of healthy volunteers aged 11 to 15 participants , and from 19 to 25 years over two classic version reasoning tasks "with" and "without" cognitive conflict and realized on an MRI
Measured: Day 1
Secondary outcomes (3)
the activity recorded in the whole brain
the activity recorded in the whole brain of healthy volunteers aged 11 to 15 participants , and 19 to 25 years in two classic version reasoning tasks "with" and "without" cognitive conflict and carried out during the examination MRI
Measured: Day 1
response time
response time recorded version "with" versus "without" cognitive conflict , participants in healthy volunteers aged 11-15 and 19-25 years in two classic reasoning tasks performed during an MRI
Measured: Day 1
brain activity measured in the CSF in two classic reasoning tasks
Compare brain activity measured in the CSF in two classic reasoning tasks in both " with" and "without" conflict for each of the healthy volunteers participating groups
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startSep 2014
- Primary completionOct 2016 (estimated)
- Study completionOct 2017 (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.
- 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Cyceron
- Responsible party
- Sponsor
- Investigators
- Wym WN De Nyes, PhD, Study director, Cyceron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788968
- Sponsor's protocol ID
- 2014-A00935-42
- Acronym
- DéCoR
- Status last verified
- May 2016
- First submitted
- 9 Feb 2016
- Last updated
- 2 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conflict Detection Development During the Reasoning
- ClinicalTrials.gov ID
- NCT02788968
- Acronym / sponsor ID
- DéCoR / 2014-A00935-42
- Conditions
- Healthy Volunteers
- Keywords
- Psychology and Cognitive Neuroscience of development, Adolescent and young adult healthy volunteers, Anatomical and functionally Magnetic Resonance Imaging (MRI), Conflict detection, Reasoning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Cyceron
- Study start
- Sep 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 2 Jun 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.
The study to explore the development of these abilities with age, and called "Development of the conflict detection during the reasoning - Decor" will take place at CYCERON center and will include two groups of 22 participants: adolescents and young adults (N = 44). More specifically, this study aims to compare the changes in the brain of adolescents and young adults when conducting reasoning tasks for which there may be a cognitive conflict. Both groups of participants then spend an MRI (Magnetic Resonance Imaging) focused on the brain and in which they will carry out two classic tasks covering the main areas of reasoning (probabilistic and economic). Each of these tasks will be manipulated to include, or not, of making information call intuition to create or not a conflict between the correct answer (logic, normative) and biased response (intuitive, heuristic). Because of the major implication of this brain region in cognitive inhibition processes [of intuitive answer], measured brain activity in the anterior cingulate cortex (ACC) during both tasks version "with" or "no" conflict will be compared between groups. To better understand the links between the development of the CCA from adolescence to adulthood and conflict detection, activity measurements will be correlated with a part in morphometric measurements taken from the same area (volume Substance Grise - SG; characteristics of cortical sulci) and secondly to cognitive measures (executive functions - inhibitory control). This cross-sectional study focused on two age groups: 11-15 years and 19-25 years. For each age group, the participation of men / boys and women / girls will be balanced up.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents | Other | Other: MRIMRI 11-15 years |
| Young adults | Experimental | Other: MRIMRI 19-25 years |
Who may qualify
- Ages
- 11 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Healthy and educated adolescents aged 11-15 years
- boy or girl
- French mother tongue
- Handedness : right
- Having been informed by the teen booklet and given its written consent, and whose parents or legal guardian will be ( a) signed the informed consent sheet of the protocol
Key exclusion criteria (18 listed)
- Does not meet the targeted age groups
- Presents against -indications to MRI (severe claustrophobia , foreign bodies cons -indicated )
- This chronic intake of alcohol or drugs
- Cognitive disorders who could testify sudden onset of a stroke ; a history of head injury with loss of consciousness for more than 1 hour , or encephalitis
- A neurological chronic condition , psychiatric, endocrine , hepatic and infectious
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 |
|---|---|---|
| MRIConventional reasoning tasks in both " with" and "without" cognitive conflict and realized during an MRI | Other | Adolescents, Young adults |
Primary outcome
brain activity in the anterior cingulate cortex (ACC )
Time frame: Day 1
measured brain activity in the anterior cingulate cortex (ACC ) of healthy volunteers aged 11 to 15 participants , and from 19 to 25 years over two classic version reasoning tasks "with" and "without" cognitive conflict and realized on an MRI
3 secondary outcomes
the activity recorded in the whole brain
Time frame: Day 1
response time
Time frame: Day 1
brain activity measured in the CSF in two classic reasoning tasks
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
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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.
Wym WN De Nyes, PhD study director
Cyceron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Healthy Volunteers, run by University Hospital, Caen 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 14 inclusion and 18 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 2 Jun 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 Olivier EO Etard, MCU-PH (02.31.06.45.26 ext. + 33, etard-o@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain activity in the anterior cingulate cortex (ACC ) (time frame: Day 1). 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 2 Jun 2016.