Organization of the Cingulate Cortex (EEG-Feedback)
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|ClinicalTrials.gov Identifier: NCT03119870|
Recruitment Status : Completed
First Posted : April 19, 2017
Last Update Posted : July 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Other: Train Other: MRI Other: EEG||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Structure-function Relationships Within the Cingulate Cortex|
|Actual Study Start Date :||January 9, 2013|
|Actual Primary Completion Date :||September 6, 2013|
|Actual Study Completion Date :||July 4, 2017|
Each subject will conduct 3 sessions, i.e. a training session, an anatomical MRI session and an EEG session. The first session will be to train the subject to carry out the different behavioral tasks that he will then have to perform during the session of EEG.
Each subject will be trained to perform a trial-error learning task. In this task, three visual stimuli will be presented to the subject. The subject will have to find by trial-error, the one associated with positive feedback, the other stimuli being associated with negative feedback (search period). Once the stimulus is associated with positive feedback, the subject will perform a period of repetition during which he will choose the stimulus associated with positive feedback. Two variants of the task will be used: a variant in which feedback will be visual (ie positive feedback = green square, negative feedback = red square) and a variant in which feedback will be fruit juice (ie positive feedback = Fruit juice (but less than 2ml), negative feedback = no volume or small volume of fruit juice).
Once the tasks are learned, each subject will participate in an MRI session during which an anatomical scan will be obtained. For each task, the time of presentation of the stimuli will be 2s. During this time, the subject should indicate his choice of stimulus. After a delay of 2s, feedback will be presented for 1s. Each test shall be separated by an inter-test delay of 3s. The presentation of the stimuli and the control of the answers will be managed by the E-prime or Presentation software.
Once the tasks are learned, each subject will participate in an MRI session during which an anatomical scan will be obtained and then an EEG session during which he will perform the task learned.For each task, the time of presentation of the stimuli will be 2s. During this time, the subject should indicate his choice of stimulus. After a delay of 2s, feedback will be presented for 1s. Each test shall be separated by an inter-test delay of 3s. The presentation of the stimuli and the control of the answers will be managed by the E-prime or Presentation software.
- Resting state fMRI data [ Time Frame: 3 years ]BOLD signal will be analyzed in the low frequency band (0.1-0.01Hz). 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.
- EEG data [ Time Frame: 3 years ]If recordings are too noisy (if only <30% of trials survive the denoising process), subject will be excluded from final analysis.
- Behavioral data in the EEG experiment [ Time Frame: 3 years ]Performance in the task will be assessed. If performance in the task is <80%, subjects will be excluded in the final 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): NCT03119870
|Hospices Civils de Lyon, Groupement Hospitalier Est|
|Bron, France, 69677|
|Principal Investigator:||Christian SCHEIBER, MD||Hospices Civils de Lyon|