Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-26 @ 1:19 AM
Study NCT ID:
NCT03483233
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2018-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neural Bases of the Check Process
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-28', 'studyFirstSubmitDate': '2018-03-07', 'studyFirstSubmitQcDate': '2018-03-23', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measuring changes in brain activity in regions of interest when performing cognitive tasks.', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'Behavior: Measurement of reaction times of correct answer during cognitive task.\n\nfMRI and EEG: Brain activity signal,'}, {'measure': 'Measuring changes in brain activity in regions of interest when performing cognitive tasks.', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'Behavior: Measurement of % of correct answer during cognitive task.'}, {'measure': 'Measuring changes in brain activity in regions of interest when performing cognitive tasks.', 'timeFrame': 'through study completion, an average of 3 years', 'description': '\\- 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.\n\nMeasurement of the amplitude of the change of the electrical signal in EEG according to the different cognitive tasks in the different regions of interest.'}], 'secondaryOutcomes': [{'measure': '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)', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'calculate with the bold signal (spectroscopy)'}, {'measure': '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)', 'timeFrame': 'through study completion, an average of 3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gyrus Cinguli', 'Cognitive Control Process', 'Check process', 'Decision Making', 'fMRI'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': "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.\n\nHowever, 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.\n\nThe 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.\n\nThe purpose of this research campaign is to determine, through functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) in healthy human subjects:\n\n1. the location and role of the MCC region involved in normal check decision processes,\n2. determine the identity of the entire network involved"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults age range 20-45 years\n* being able to provide a written consent form\n* having a social insurance\n* have a normal vision (with or without corrections)\n* Right-handed\n\nExclusion Criteria:\n\n* Subjects with MRI contraindications (e.g. pacemaker, claustrophobia, metal in the body, etc…).\n* Pregnant subjects\n* Subjects with neurological history\n* Subjects must be willing to be advise in case of discovery of brain abnormality.'}, 'identificationModule': {'nctId': 'NCT03483233', 'acronym': 'Check', 'briefTitle': 'Neural Bases of the Check Process', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Neural Bases of the Check Process', 'orgStudyIdInfo': {'id': '69HCL17_0143'}, 'secondaryIdInfos': [{'id': '2018-A00405-50', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fMRI and EEG study', 'interventionNames': ['Other: fMRI and EEG study']}], 'interventions': [{'name': 'fMRI and EEG study', 'type': 'OTHER', 'description': 'fMRI and EEG study', 'armGroupLabels': ['fMRI and EEG study']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bron', 'country': 'France', 'facility': 'Inserm U1208', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'overallOfficials': [{'name': 'Emmanuel Procyk', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'INSERM U1208'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}