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CompletedNCT03483233CheckUpdated Dec 29, 2025

Neural Bases of the Check Process

An interventional study of fMRI and EEG study in Healthy Volunteers, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-29.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Not applicable
Ages
20 Years to 45 Years
Sex
All
01

Study 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
02

Conditions studied

  • Healthy Volunteers

Keywords

  • Gyrus Cinguli
  • Cognitive Control Process
  • Check process
  • Decision Making
  • fMRI
03

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    fMRI and EEG study

    Other: fMRI and EEG study

Interventions

  • OtherfMRI and EEG study

    fMRI and EEG study

05

What researchers measure

Primary outcomes

  1. 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,

    Time frame: through study completion, an average of 3 years

  2. Measuring changes in brain activity in regions of interest when performing cognitive tasks.

    Behavior: Measurement of % of correct answer during cognitive task.

    Time frame: through study completion, an average of 3 years

  3. 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.

    Time frame: through study completion, an average of 3 years

Secondary outcomes

  1. 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)

    Time frame: through study completion, an average of 3 years

  2. 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)

    Time frame: through study completion, an average of 3 years

06

Study locations

1 site
  • Inserm U1208
    Bron, France
07

References and documents

Publications

  • Stoll FM, Fontanier V, Procyk E. Specific frontal neural dynamics contribute to decisions to check. Nat Commun. 2016 Jun 20;7:11990. doi: 10.1038/ncomms11990. PubMed 27319361 ↗
08

Registry details

Key details

Study ID
NCT03483233
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Mar 30, 2018
Start date
Nov 23, 2018
Primary completion
Jan 16, 2020
Completion
Jan 16, 2020
Last update
Dec 29, 2025

Study contacts

Emmanuel Procyk
principal investigator · INSERM U1208

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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