NCT03119870

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2013

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2017

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

8 months

First QC Date

March 9, 2017

Last Update Submit

July 6, 2017

Conditions

Keywords

fMRIEEGbehaviorcingulate cortex

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

1

EXPERIMENTAL

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.

Other: TrainOther: MRIOther: EEG

Interventions

TrainOTHER

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).

1
MRIOTHER

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.

1
EEGOTHER

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.

1

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • being able to provide a writen consent form
  • having a social insurance
  • have a normal vision (with or without corrections)
  • Right-handed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon, Groupement Hospitalier Est

Bron, 69677, France

Location

MeSH Terms

Conditions

Behavior

Study Officials

  • Christian SCHEIBER, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2017

First Posted

April 19, 2017

Study Start

January 9, 2013

Primary Completion

September 6, 2013

Study Completion

July 4, 2017

Last Updated

July 11, 2017

Record last verified: 2017-07

Locations