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Cognitive Adaptation (ADAPCO)

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ClinicalTrials.gov Identifier: NCT03119909
Recruitment Status : Unknown
Verified October 2018 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : April 19, 2017
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE March 9, 2017
First Posted Date  ICMJE April 19, 2017
Last Update Posted Date October 5, 2018
Actual Study Start Date  ICMJE September 24, 2015
Estimated Primary Completion Date August 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Adaptation
Official Title  ICMJE Cognitive Adaptation and Frontal Cortex
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Other: First session of fMRI: localization of the premotor areas of the medial frontal cortex
    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.
  • Other: Second fMRI session
    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.
  • Other: Third fMRI Session
    This session is identical to the second session but the subject will have to respond by performing saccadic ocular responses.
  • Other: Training fMRI session
    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.
  • Other: Pilot behavioral 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).
  • Other: fMRI Study
    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 Arms  ICMJE
  • 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.
    Interventions:
    • 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

    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)

    Interventions:
    • Other: Pilot behavioral study
    • Other: fMRI Study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 13, 2017)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 24, 2020
Estimated Primary Completion Date August 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03119909
Other Study ID Numbers  ICMJE 69HCL16_0683
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philippe Domenech, MD Hôpital Henri Mondor
PRS Account Hospices Civils de Lyon
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP