HealthyADAPCONCT03119909
Cognitive Adaptation
A study testing First session of fMRI: localization of the premotor areas of the medial frontal cortex, Second fMRI session and Third fMRI Session in people with Healthy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
A hallmark of our survival in the real world and of our capacity to navigate the complex social interactions of human society is our ability to show behavioral adaptation. Adaptation can be necessary for a number of reasons, making the study of the process challenging. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- First session of fMRI: localization of the premotor areas of the medial frontal cortex, Second fMRI session and Third fMRI Session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 24 Sep 2015to 24 Sep 2022
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- being able to provide a written consent form
- having a social insurance
- have a normal vision (with or without corrections)
- Right-handed
Who cannot join
- Subjects with MRI contraindications (e.g. pacemaker, claustrophobia, metal in the body, etc…).
- Subjects must be willing to be advise in case of discovery of brain abnormality.
- History of neurological or psychiatric illness
- Pregnant or nursing women
- Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of liberty
Trial locations and contacts
1 site in 1 country.
Philippe Domenech, MD contact
France1 site, 1 recruiting
- Recruiting
Hôpital Henri Mondor
Créteil, 94000
Philippe Domenech, MD, philippe.domenech@inserm.fr
About this study
Official title: Cognitive Adaptation and Frontal Cortex
A hallmark of our survival in the real world and of our capacity to navigate the complex social interactions of human society is our ability to show behavioral adaptation. Adaptation can be necessary for a number of reasons, making the study of the process challenging. Two classes of event can signal a need for adaptation: 1) Events caused by one's own actions and specifically FeedBack -FB- from those actions (e.g. the investigators adapt their strategy after an erroneous choice), and 2) Events not linked to our actions, specifically Action-InDependent Events -AiDE- (e.g. the investigators adapt their strategy after a change of rule). These two types of information - FB and AiDE - will frequently occur concurrently. A critical and difficult part of adapting appropriately involves resolving the difference between the two. So for example an incorrect FB can occur because the investigators made an error, or because something unexpected in the environment has changed -the rule switched, someone cheated, etc. The Investigators must work out which it is, as they will frequently require different behavioral adaptations. Their task is made even more complex by the fact that the dynamics of evidence accumulation after FB vs AiDE are very different. FB has a direct temporal and causal link to an executed action, which means that the investigators are certain to derive information about a given action from a given FB. In contrast, AiDE have no such contiguity and no initial relation to actions, which means that the investigators must accumulate evidence to identify the appropriate adaptation to an AiDE. So the crucial dilemma is this: after an unwanted outcome, should the investigators adapt as if they made an error and received a negative FB, or should they continue to accumulate evidence as if there has been an AiDE to which they need to know how to adapt. Animals are able to resolve this credit assignment problem, as evidenced by their ability to appropriately adapt their behavior. A breakdown of this ability to link unexpected events to their correct cause would seem to be at the source of impairments in a wide range of psychological and neurological disorders, from addiction and OCD to psychological symptoms in Parkinson's disease. Yet the neural basis of this process is currently unknown, and FB and AiDE processing have been assessed separately so far. ADAPCO will provide unprecedented characterization of brain systems critically involved in learning from and adapting to FB, AiDE, and their interactions, thanks to fMRI studies.
- Conditions
- Healthy
- Being tested
- First session of fMRI: localization of the premotor areas of the medial frontal cortex, Second fMRI session, Third fMRI Session, Training fMRI session, Pilot behavioral study
- Keywords
- fMRI, cingulate cortex, adaptation, frontal cortex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First session of fMRI: localization of the premotor areas of the medial frontal cortexOther
Subjects should perform simple tasks to map the premotor areas of the medial frontal cortex. In this context, they will have to perform hand, tongue, ocular movements for about 20s. Additionally, as part of a control condition, they will need to perform eye fixation on a cross shown at the center of the screen for about 20s.
Second fMRI sessionOther
The subjects will position their left and right thumbs on response buttons. Each trial will begin with the appearance of one of 2 possible indexes. It will be an unknown abstract visual stimulus). After a variable delay of 0.5 to 6s (average = 2s), a blue or yellow circle will appear on the left or right of the screen.
Third fMRI SessionOther
This session is identical to the second session but the subject will have to respond by performing saccadic ocular responses.
Training fMRI sessionOther
The training session will consist in training the subject to carry out the different behavioral tasks that he will then have to perform during the sessions of fMRI.
Pilot behavioral studyOther
In a pilot study, 30 subjects will participate in a behavioral study (2 sessions of 2 hours each) aimed at establishing the learning characteristics of the different types of rare events unrelated to actions (visual and sensorimotors on the hand).
fMRI StudyOther
Each subject will participate in 2 fMRI sessions of about 2 hours each: a first session in which a first version of the task will be presented and a second session in which the second version of the task will be presented.
| Study group | Role | What they receive |
|---|---|---|
| Learning of actions-events associations | Other | Each subject will conduct 4 sessions, i.e. a training session and three fMRI sessions. The first session will consist in training the subject to carry out the different behavioral tasks that he will then have to perform during the sessions of fMRI. Receives: Other: First session of fMRI: localization of the premotor areas of the medial frontal cortex; Other: Second fMRI session; Other: Third fMRI Session; Other: Training fMRI session |
| Learning of action-event associations not linked to action | Other | This study is divided into two parts: a pilot behavioral study to determine the learning characteristics of non-action events and an fMRI study to study the neural networks involved in this type of learning.
30 subjects will participate in the behavioral study and 60 will participate in the fMRI study) Receives: Other: Pilot behavioral study; Other: fMRI Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral data
Performance in the task will be assessed. Only subjects with performance in the task >80% in the last functional run will be included in the final analysis.
Measured: 3 years
fMRI data
BOLD signal will be analyzed in relation to the events of the task of all subjects. Images must be not too much distorted to allow data analysis. As such, if a subject moved too much (translation>10mm; rotation>5°) the corresponding data will be excluded from the analysis.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start24 Sep 2015
- Primary completion24 Aug 2022 (estimated)
- Study completion24 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Domenech, MD, Principal investigator, Henri Mondor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119909
- Sponsor's protocol ID
- 69HCL16_0683
- Acronym
- ADAPCO
- Status last verified
- Jul 2021
- First submitted
- 9 Mar 2017
- Last updated
- 21 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Adaptation and Frontal Cortex
- ClinicalTrials.gov ID
- NCT03119909
- Acronym / sponsor ID
- ADAPCO / 69HCL16_0683
- Conditions
- Healthy
- Keywords
- fMRI, cingulate cortex, adaptation, frontal cortex
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 24 Sep 2015 (actual)
- Primary completion
- 24 Aug 2022 (estimated)
- Study completion
- 24 Sep 2022 (estimated)
- First posted
- 19 Apr 2017 (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.
A hallmark of our survival in the real world and of our capacity to navigate the complex social interactions of human society is our ability to show behavioral adaptation. Adaptation can be necessary for a number of reasons, making the study of the process challenging. Two classes of event can signal a need for adaptation: 1) Events caused by one's own actions and specifically FeedBack -FB- from those actions (e.g. the investigators adapt their strategy after an erroneous choice), and 2) Events not linked to our actions, specifically Action-InDependent Events -AiDE- (e.g. the investigators adapt their strategy after a change of rule). These two types of information - FB and AiDE - will frequently occur concurrently. A critical and difficult part of adapting appropriately involves resolving the difference between the two. So for example an incorrect FB can occur because the investigators made an error, or because something unexpected in the environment has changed -the rule switched, someone cheated, etc. The Investigators must work out which it is, as they will frequently require different behavioral adaptations. Their task is made even more complex by the fact that the dynamics of evidence accumulation after FB vs AiDE are very different. FB has a direct temporal and causal link to an executed action, which means that the investigators are certain to derive information about a given action from a given FB. In contrast, AiDE have no such contiguity and no initial relation to actions, which means that the investigators must accumulate evidence to identify the appropriate adaptation to an AiDE. So the crucial dilemma is this: after an unwanted outcome, should the investigators adapt as if they made an error and received a negative FB, or should they continue to accumulate evidence as if there has been an AiDE to which they need to know how to adapt. Animals are able to resolve this credit assignment problem, as evidenced by their ability to appropriately adapt their behavior. A breakdown of this ability to link unexpected events to their correct cause would seem to be at the source of impairments in a wide range of psychological and neurological disorders, from addiction and OCD to psychological symptoms in Parkinson's disease. Yet the neural basis of this process is currently unknown, and FB and AiDE processing have been assessed separately so far. ADAPCO will provide unprecedented characterization of brain systems critically involved in learning from and adapting to FB, AiDE, and their interactions, thanks to fMRI studies.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Learning of actions-events associations | Other | Other: First session of fMRI: localization of the premotor areas of the medial frontal cortex, Other: Second fMRI session, Other: Third fMRI Session, Other: Training fMRI sessionEach subject will conduct 4 sessions, i.e. a training session and three fMRI sessions. The first session will consist in training the subject to carry out the different behavioral tasks that he will then have to perform during the sessions of fMRI. |
| Learning of action-event associations not linked to action | Other | Other: Pilot behavioral study, Other: fMRI StudyThis study is divided into two parts: a pilot behavioral study to determine the learning characteristics of non-action events and an fMRI study to study the neural networks involved in this type of learning. 30 subjects will participate in the behavioral study and 60 will participate in the fMRI study) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- being able to provide a written consent form
- having a social insurance
- have a normal vision (with or without corrections)
- Right-handed
Key exclusion criteria (5 listed)
- Subjects with MRI contraindications (e.g. pacemaker, claustrophobia, metal in the body, etc…).
- Subjects must be willing to be advise in case of discovery of brain abnormality.
- History of neurological or psychiatric illness
- Pregnant or nursing women
- Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of liberty
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 |
|---|---|---|
| First session of fMRI: localization of the premotor areas of the medial frontal cortexSubjects should perform simple tasks to map the premotor areas of the medial frontal cortex. In this context, they will have to perform hand, tongue, ocular movements for about 20s. Additionally, as part of a control condition, they will need to perform eye fixation on a cross shown at the center of the screen for about 20s. | Other | Learning of actions-events associations |
| Second fMRI sessionThe subjects will position their left and right thumbs on response buttons. Each trial will begin with the appearance of one of 2 possible indexes. It will be an unknown abstract visual stimulus). After a variable delay of 0.5 to 6s (average = 2s), a blue or yellow circle will appear on the left or right of the screen. | Other | Learning of actions-events associations |
| Third fMRI SessionThis session is identical to the second session but the subject will have to respond by performing saccadic ocular responses. | Other | Learning of actions-events associations |
| Training fMRI sessionThe training session will consist in training the subject to carry out the different behavioral tasks that he will then have to perform during the sessions of fMRI. | Other | Learning of actions-events associations |
| Pilot behavioral studyIn a pilot study, 30 subjects will participate in a behavioral study (2 sessions of 2 hours each) aimed at establishing the learning characteristics of the different types of rare events unrelated to actions (visual and sensorimotors on the hand). | Other | Learning of action-event associations not linked to action |
| fMRI StudyEach subject will participate in 2 fMRI sessions of about 2 hours each: a first session in which a first version of the task will be presented and a second session in which the second version of the task will be presented. | Other | Learning of action-event associations not linked to action |
Primary outcome
Behavioral data
Time frame: 3 years
Performance in the task will be assessed. Only subjects with performance in the task >80% in the last functional run will be included in the final analysis.
fMRI data
Time frame: 3 years
BOLD signal will be analyzed in relation to the events of the task of all subjects. Images must be not too much distorted to allow data analysis. As such, if a subject moved too much (translation>10mm; rotation>5°) the corresponding data will be excluded from the analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
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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.
Philippe Domenech, MD contact
Philippe Domenech, MD principal investigator
Henri Mondor University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First session of fMRI: localization of the premotor areas of the medial frontal cortex, Second fMRI session and Third fMRI Session in people with Healthy, 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 4 inclusion and 5 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 21 Jul 2021. 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 Philippe Domenech, MD (philippe.domenech@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral data (time frame: 3 years). 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 21 Jul 2021.