Neural Bases of the Check Process

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: fMRI and EEG study

• Registration Number: NCT03483233
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-03-23
• Study First Posted: 2018-03-30
• Study Start: 2018-11-23
• Primary Completion: 2020-01-16
• Study Completion: 2020-01-16
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fMRI and EEG study	fMRI and EEG study	-

Primary Outcome Measures

Name	Time	Method
Measuring changes in brain activity in regions of interest when performing cognitive tasks.	through study completion, an average of 3 years	- 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.

Secondary Outcome Measures

Name	Time	Method
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
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)	through study completion, an average of 3 years	calculate with the bold signal (spectroscopy)

Trial Locations

Locations (1)

Inserm U1208; 🇫🇷 Bron, France