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Neural Bases of the Check Process (Check)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483233
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: fMRI and EEG study Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Neural Bases of the Check Process
Actual Study Start Date : November 23, 2018
Estimated Primary Completion Date : July 23, 2021
Estimated Study Completion Date : July 23, 2021

Arm Intervention/treatment
Experimental: fMRI and EEG study Other: fMRI and EEG study
fMRI and EEG study




Primary Outcome Measures :
  1. Measuring changes in brain activity in regions of interest when performing cognitive tasks. [ Time Frame: through study completion, an average of 3 years ]

    Behavior: Measurement of reaction times of correct answer during cognitive task.

    fMRI and EEG: Brain activity signal,


  2. Measuring changes in brain activity in regions of interest when performing cognitive tasks. [ Time Frame: through study completion, an average of 3 years ]
    Behavior: Measurement of % of correct answer during cognitive task.

  3. Measuring changes in brain activity in regions of interest when performing cognitive tasks. [ Time Frame: 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 :
  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) [ Time Frame: through study completion, an average of 3 years ]
    calculate with the bold signal (spectroscopy)

  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 ]


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483233


Contacts
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Contact: Emmanuel Procyk 0472913456 Emmanuel.procyk@inserm.fr

Locations
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France
Inserm U1208 Recruiting
Bron, France
Contact: Emmanuel Procyk    0472913456    Emmanuel.procyk@inserm.fr   
Principal Investigator: Emmanuel Procyk         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Emmanuel Procyk INSERM U1208

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03483233    
Other Study ID Numbers: 69HCL17_0143
2018-A00405-50 ( Other Identifier: ID-RCB )
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Gyrus Cinguli
Cognitive Control Process
Check process
Decision Making
fMRI