- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03119909
Cognitive Adaptation (ADAPCO)
July 20, 2021 updated by: Hospices Civils de Lyon
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
90
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 Contact
- Name: Philippe Domenech, MD
- Email: philippe.domenech@inserm.fr
Study Contact Backup
- Name: Céline Amiez, PhD
- Phone Number: +33 0472913450
- Email: celine.amiez@inserm.fr
Study Locations
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-
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Creteil, France, 94000
- Recruiting
- Hopital Henri Mondor
-
Contact:
- Philippe Domenech, MD
- Email: philippe.domenech@inserm.fr
-
-
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
20 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- being able to provide a written consent form
- having a social insurance
- have a normal vision (with or without corrections)
- Right-handed
Exclusion Criteria:
- 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
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Learning of actions-events associations
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.
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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.
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.
This session is identical to the second session but the subject will have to respond by performing saccadic ocular responses.
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.
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Other: Learning of action-event associations not linked to action
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) |
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).
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 years
|
|
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.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Philippe Domenech, MD, Henri Mondor University Hospital
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)
September 24, 2015
Primary Completion (Anticipated)
August 24, 2022
Study Completion (Anticipated)
September 24, 2022
Study Registration Dates
First Submitted
March 9, 2017
First Submitted That Met QC Criteria
April 13, 2017
First Posted (Actual)
April 19, 2017
Study Record Updates
Last Update Posted (Actual)
July 21, 2021
Last Update Submitted That Met QC Criteria
July 20, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 69HCL16_0683
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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