Cognitive Adaptation (ADAPCO)
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|ClinicalTrials.gov Identifier: NCT03119909|
Recruitment Status : Recruiting
First Posted : April 19, 2017
Last Update Posted : October 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Healthy||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 Other: Pilot behavioral study Other: fMRI Study||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Cognitive Adaptation and Frontal Cortex|
|Actual Study Start Date :||September 24, 2015|
|Estimated Primary Completion Date :||August 24, 2020|
|Estimated Study Completion Date :||September 24, 2020|
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.
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.
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)
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119909
|Contact: Philippe Domenech, MDemail@example.com|
|Contact: Céline Amiez, PhD||0472913450 ext +firstname.lastname@example.org|
|Hôpital Henri Mondor||Recruiting|
|Creteil, France, 94000|
|Contact: Philippe Domenech, MD email@example.com|
|Principal Investigator:||Philippe Domenech, MD||Hôpital Henri Mondor|