Organization of the Cingulate Cortex

Healthy Clinical Trial

— EEG-Feedback  

Official title:

Structure-function Relationships Within the Cingulate Cortex

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03119870
• Other study ID #: 69HCL16_0659
• Status: Completed
• Phase: N/A
• First received: March 9, 2017
• Last updated: July 6, 2017
• Start date: January 9, 2013
• Est. completion date: July 4, 2017

Study information

• Verified date: July 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Efficient evaluation and monitoring of actions and outcomes are a key feature of primates' efficient adaptive cognition. Deficits in evaluating one's own actions and their consequences is a key feature of prominent disorders such as obsessive compulsive disorders (OCD), schizophrenia, and anxiety. The Investigators know that these evaluative processes implicate medial structures of the brain that are related both to old limbic functions and to more recently evolved higher executive functions. Brain potentials related to performance monitoring have attracted a lot of interest in cognitive neuroscience but also in the clinical domain because they appear to be altered in different neurological or psychiatric disorders, such as schizophrenia, OCD, or anxiety, and could become biomarkers of pathologies. But the neural sources of these markers are not fully determined and are currently highly debated. In addition, our work suggests that non pathological factors, such as normal morphological cortical variations, could affect those markers. Understanding performance monitoring, acting directly on medial cortex, or using electrophysiological markers in clinic are thus currently problematic and challenging. This is mostly because structure-function relationships in the medial wall are ill defined for historical, conceptual, and methodological reasons. Importantly, although individual variability of brain morphology impedes precise assessment of structure function relationships, this variability is almost never taken into account. EEG-Feedback aims to resolve these issues by evaluating the consequences of individual variability in cingulate cortex morphology on 1) surface EEG markers of feedback monitoring and 2) functional connectivity patterns thanks to resting-state fMRI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 4, 2017
• Est. primary completion date: September 6, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• being able to provide a writen 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.

• No history of known neurological or psychiatric illness

• Pregnant or nursing women

• Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights or liberty, as well as legal persons protected by law

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Train
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).
• MRI
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.
• EEG
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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon, Groupement Hospitalier Est	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting state fMRI data	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.	3 years
Primary	EEG data	If recordings are too noisy (if only <30% of trials survive the denoising process), subject will be excluded from final analysis.	3 years
Primary	Behavioral data in the EEG experiment	Performance in the task will be assessed. If performance in the task is <80%, subjects will be excluded in the final analysis.	3 years