NCT03483233

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable healthy-volunteers

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

November 23, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2020

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

March 7, 2018

Last Update Submit

December 19, 2025

Conditions

Healthy Volunteers

Keywords

Gyrus CinguliCognitive Control ProcessCheck processDecision MakingfMRI

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (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 concentration of Acide γ-aminobutyrique (GABA)

    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

Study Arms (1)

fMRI and EEG study

EXPERIMENTAL
Other: fMRI and EEG study

Interventions

fMRI and EEG studyOTHER

fMRI and EEG study

fMRI and EEG study

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inserm U1208

Bron, France

Location

Related Publications (1)

  • 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.

    PMID: 27319361RESULT

Study Officials

  • Emmanuel Procyk

    INSERM U1208

    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 7, 2018

First Posted

March 30, 2018

Study Start

November 23, 2018

Primary Completion

January 16, 2020

Study Completion

January 16, 2020

Last Updated

December 29, 2025

Record last verified: 2025-12

Locations

FR(1)