Neural Bases of the Check Process (Check)

Effective exploration of the environment, check for information to improve one's own performance, are fundamental abilities of human cognition. These abilities are dependent on the process of cognitive control.

However, they are clearly impaired and uncontrollable in certain behavioral disorders such as obsessive-compulsive disorder (OCD). Compulsive checks of these patients, spontaneously associated with a feeling of intense uncertainty, suggest disturbances of evaluative and metacognitive functions. However, no biological observations have yet been able to feed these hypotheses.

The evaluation of decisions and actions involves the middle cingulate cortex (MCC) (which belongs to a cortico-subcortical network structurally and functionally altered in OCD patients). Cingulotomy has long been used as a therapy in severe OCD, with However, the precise part of the cingulate cortex that contributes to check (and its pathological forms) remains to be discovered.

The purpose of this research campaign is to determine, through functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) in healthy human subjects:

1. the location and role of the MCC region involved in normal check decision processes,
2. determine the identity of the entire network involved

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: fMRI and EEG study

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France
    • Inserm U1208

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adults age range 20-45 years
• 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…).
• Pregnant subjects
• Subjects with neurological history
• Subjects must be willing to be advise in case of discovery of brain abnormality.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fMRI and EEG study	Other: fMRI and EEG study; fMRI and EEG study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring changes in brain activity in regions of interest when performing cognitive tasks.	Behavior: Measurement of reaction times of correct answer during cognitive task. fMRI and EEG: Brain activity signal,	through study completion, an average of 3 years
Measuring changes in brain activity in regions of interest when performing cognitive tasks.	Behavior: Measurement of % of correct answer during cognitive task.	through study completion, an average of 3 years
Measuring changes in brain activity in regions of interest when performing cognitive tasks.	- Measurement of the amplitude of the BOLD signal change in MRI according to the different cognitive tasks in the different regions of interest. Measurement of resting GABA and Glutamate concentrations in the different regions of interest. Measurement of the amplitude of the change of the electrical signal in EEG according to the different cognitive tasks in the different regions of interest.	through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculation of the correlations in the regions of interest of the individual values of the Blood Oxygen Level Dependent (BOLD) signal with the data of the concentration of Acide γ-aminobutyrique (GABA)	calculate with the bold signal (spectroscopy)	through study completion, an average of 3 years
Calculation of the correlations in the regions of interest of the individual values of the Blood Oxygen Level Dependent (BOLD) signal with the data of the amplitude of the electrical signal (EEG)		through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Emmanuel Procyk, Inserm U1208

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2018
• Primary Completion (Actual): January 16, 2020
• Study Completion (Actual): January 16, 2020

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (Actual): March 30, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Decision Making; fMRI; Gyrus Cinguli; Cognitive Control Process; Check process
• Other Study ID Numbers: 69HCL17_0143; 2018-A00405-50 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No