Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-03-03 @ 12:43 AM
Study NCT ID:
NCT05774834
Status:
RECRUITING
Last Update Posted:
2025-04-11
First Post:
2023-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neural Bases of Decision-making in Healthy Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2023-03-07', 'studyFirstSubmitQcDate': '2023-03-07', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Behavioral performance 1: Decision-making skills', 'timeFrame': 'MRI-acquisition day 1', 'description': 'Participants\' decision-making performance will be assessed in terms of "loss aversion" (i.e., the overweighting of potential losses compared with gains), after removing the potential confounding effect of risk aversion'}], 'secondaryOutcomes': [{'measure': 'Behavioral performance 2: Executive functioning skills', 'timeFrame': 'MRI-acquisition day 1', 'description': "Participants' executive performance will be assessed in terms of well-know metrics such as selective attention and inhibitory control, measured with the Stroop Task and the Stop-Signal-Task, respectively."}, {'measure': 'Brain activity underlying decision-making and executive performance', 'timeFrame': 'MRI-acquisition day 1', 'description': 'Standard pipelines and pre-processing of fMRI task-related data will be used to detect regional changes of brain activity associated with individual differences in decision-making and executive performance.'}, {'measure': 'Brain structure related to decision-making and executive performance', 'timeFrame': 'MRI-acquisition day 1', 'description': 'Standard pipelines and pre-processing of MRI T1-weighted data will be used to detect patterns of GM volume/density and structural connectivity associated with individual differences in decision-making and executive performance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['decision-making', 'executive functioning', 'fMRI', 'ageing'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The goal of this single center non-interventional fMRI study is to assess the neural bases of decision-making and executive functioning in healthy individuals,and whether/how their responsiveness is modulated by ageing. The main questions it aims to answer are:\n\n1. are there specific neural correlates for ageing effects on executive functioning (particularly inhibitory control) and decision-making?\n2. Is there a relationship, at the behavioral and neural levels, between ageing-related changes in executive functioning and decision-making?\n\nHealthy participants will be recruited for\n\n1. a behavioral assessment including multiple tests of decision-making and executive functioning/inhibitory control;\n2. a fMRI session to collect data concerning a) brain activity associated with decision-making and executive functioning, b) brain structural morphometriy (grey-matter volume/density), and c) brain structural connectivity (diffusion weighted imaging).\n\nResults will provide an useful baseline for investigating alterations of decision-making and executive functioning, and of their neural bases, in pathological conditions.', 'detailedDescription': "The fast growth of Decision Neuroscience is contributing to unveil the cognitive processes underlying choices and their neural bases. The results obtained so far show that decision-making involves neural mechanisms underpinning a complex balance between automatic appetitive or aversive drives generated by subcortical structures, and processes of executive control centered in fronto-parietal brain networks. While the role of meso-limbic structures in reinforcement learning have been widely investigated, it is much less clear to what extent are choices shaped by a) individual differences in executive skills; b) contextual factors potentially interfering with such skills, such as knowing that the outcome of those choices will impact only on one's own vs. another's welfare. This a critical gap, since executive abilities are known to decline even in physiological ageing, thus potentially interfering with the quality of choices. On this ground, this single center non-interventional fMRI study aims to provide novel insights into the relationship between executive and decision-making skills, and their possible changes with ageing, in 150 healthy individuals. This goal will be pursued by combining a behavioral assessment of decision-making and executive skills with a multimodal fMRI session including data concerning a) brain activity associated with decision-making and executive functioning in social vs. non-social contexts, b) brain structural morphometry (grey-matter volume/density), and c) brain structural connectivity (diffusion weighted imaging). The behavioral assessment will involve the main metric of decision-making (e.g., risk aversion, loss aversion, delay discounting) and executive functioning (e.g., selective attention and inhibitory control). MRI data will unveil the neural bases of individual differences in decision-making and executive performance in terms of performance-related patterns of brain activity, structure and connectivity. Results will provide an useful baseline for investigating alterations of decision-making and executive functioning, and of their neural bases, in pathological conditions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '150 healty individuals, aged 18-60 years, sampled from the general population', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy participants, as determined by screening assessments and principal investigator judgment\n* The participant must be able to comply with study requirements as judged by the principal investigator\n\nExclusion Criteria:\n\n* Any history of alcohol and/or drug abuse, addiction or suspicion of regular consumption of drugs of abuse\n* Use of any psychoactive medication, or medications known to have effect on central nervous system (CNS) or blood flow\n* Any contraindications for magnetic resonance imaging (MRI) scans or any brain/head abnormalities restricting MRI eligibility'}, 'identificationModule': {'nctId': 'NCT05774834', 'briefTitle': 'Neural Bases of Decision-making in Healthy Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Istituti Clinici Scientifici Maugeri SpA'}, 'officialTitle': 'A Non-interventional Functional Magnetic Resonance Imaging (fMRI) Study on the Neural Bases of Decision-making in Healthy Individuals', 'orgStudyIdInfo': {'id': '2137'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All healthy participants', 'description': 'All healthy participants will undergo behavioral assessment and fMRI', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['All healthy participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'state': 'Ita', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicola Canessa, Canessa', 'role': 'CONTACT', 'email': 'nicola.canessa@icsmaugeri.it', 'phone': '+390382375845'}, {'name': 'Tiziana Bachetti', 'role': 'CONTACT', 'email': 'tiziana.bachetti@icsmaugeri.it', 'phone': '+390382593210'}, {'name': 'Nicola Canessa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituti Clinici Scientifici Maugeri SpA', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Requests for sharing will assessed case by case, and data will be made available on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituti Clinici Scientifici Maugeri SpA', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istituto Universitario di Studi Superiori Pavia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}