Healthy VolunteersCheckNCT03483233
Neural Bases of the Check Process
A study testing fMRI and EEG study in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- fMRI and EEG study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2018to 16 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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:
- the location and role of the MCC region involved in normal check decision processes,
- determine the identity of the entire network involved
- Conditions
- Healthy Volunteers
- Being tested
- fMRI and EEG study
- Keywords
- Gyrus Cinguli, Cognitive Control Process, Check process, Decision Making, fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI and EEG studyOther
fMRI and EEG study
| Study group | Role | What they receive |
|---|---|---|
| fMRI and EEG study | Experimental | Not described Receives: Other: fMRI and EEG study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 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.
Measured: 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.
Measured: 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)
calculate with the bold signal (spectroscopy)
Measured: 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)
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start23 Nov 2018
- Primary completion16 Jan 2020
- Study completion16 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Procyk, Principal investigator, INSERM U1208
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483233
- Sponsor's protocol ID
- 69HCL17_0143
- Other IDs
- 2018-A00405-50
- Acronym
- Check
- Status last verified
- Dec 2025
- First submitted
- 7 Mar 2018
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Bases of the Check Process
- ClinicalTrials.gov ID
- NCT03483233
- Acronym / sponsor ID
- Check / 69HCL17_0143
- Conditions
- Healthy Volunteers
- Keywords
- Gyrus Cinguli, Cognitive Control Process, Check process, Decision Making, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Nov 2018 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- the location and role of the MCC region involved in normal check decision processes,
- determine the identity of the entire network involved
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fMRI and EEG study | Experimental | Other: fMRI and EEG study |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRI and EEG studyfMRI and EEG study | Other | fMRI and EEG study |
Primary outcome
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,
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.
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Results publication: PubMed 27319361Stoll 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Procyk principal investigator
INSERM U1208
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI and EEG study in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring changes in brain activity in regions of interest when performing cognitive tasks. (time frame: through study completion, an average of 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03483233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.