Neural Bases of the Check Process

Healthy Volunteers Clinical Trial

— Check  

Official title:

Neural Bases of the Check Process

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03483233
• Other study ID #: 69HCL17_0143
• Secondary ID: 2018-A00405-50
• Status: Completed
• Phase: N/A
• Start date: November 23, 2018
• Est. completion date: January 16, 2020

Study information

• Verified date: February 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 16, 2020
• Est. primary completion date: January 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• fMRI and EEG study
fMRI and EEG study

Locations

Country	Name	City	State
France	Inserm U1208	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	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
Primary	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
Primary	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	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 ?-aminobutyrique (GABA)	calculate with the bold signal (spectroscopy)	through study completion, an average of 3 years
Secondary	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