Healthy VolunteersNCT05774834
Neural Bases of Decision-making in Healthy Individuals
An observational study of Healthy Volunteers, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
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: 1. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Healthy Volunteers
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 10 Nov 2018to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- Adult
Study population: 150 healty individuals, aged 18-60 years, sampled from the general population
Who may be able to join
- Healthy participants, as determined by screening assessments and principal investigator judgment
- The participant must be able to comply with study requirements as judged by the principal investigator
Who cannot join
- Any history of alcohol and/or drug abuse, addiction or suspicion of regular consumption of drugs of abuse
- Use of any psychoactive medication, or medications known to have effect on central nervous system (CNS) or blood flow
- Any contraindications for magnetic resonance imaging (MRI) scans or any brain/head abnormalities restricting MRI eligibility
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituti Clinici Scientifici Maugeri SpA
Pavia, Ita, 27100
Nicola Canessa, Canessa, +390382375845, nicola.canessa@icsmaugeri.it
Tiziana Bachetti, +390382593210, tiziana.bachetti@icsmaugeri.it
About this study
Official title: A Non-interventional Functional Magnetic Resonance Imaging (fMRI) Study on the Neural Bases of Decision-making in Healthy Individuals
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:
- are there specific neural correlates for ageing effects on executive functioning (particularly inhibitory control) and decision-making?
- Is there a relationship, at the behavioral and neural levels, between ageing-related changes in executive functioning and decision-making?
Read more
Healthy participants will be recruited for
- a behavioral assessment including multiple tests of decision-making and executive functioning/inhibitory control;
- 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).
Results will provide an useful baseline for investigating alterations of decision-making and executive functioning, and of their neural bases, in pathological conditions.
Read the detailed description
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.
- Conditions
- Healthy Volunteers
- Being tested
- No intervention
- Keywords
- decision-making, executive functioning, fMRI, ageing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| All healthy participants | All healthy participants will undergo behavioral assessment and fMRI Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral performance 1: Decision-making skills
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
Measured: MRI-acquisition day 1
Secondary outcomes (3)
Behavioral performance 2: Executive functioning skills
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.
Measured: MRI-acquisition day 1
Brain activity underlying decision-making and executive performance
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.
Measured: MRI-acquisition day 1
Brain structure related to decision-making and executive performance
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.
Measured: MRI-acquisition day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start10 Nov 2018
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Universitario di Studi Superiori Pavia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774834
- Sponsor's protocol ID
- 2137
- Status last verified
- Apr 2026
- First submitted
- 7 Mar 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Requests for sharing will assessed case by case, and data will be made available on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Functional Magnetic Resonance Imaging (fMRI) Study on the Neural Bases of Decision-making in Healthy Individuals
- ClinicalTrials.gov ID
- NCT05774834
- Acronym / sponsor ID
- 2137
- Conditions
- Healthy Volunteers
- Keywords
- decision-making, executive functioning, fMRI, ageing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Collaborators
- Istituto Universitario di Studi Superiori Pavia
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 20 Mar 2023 (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.
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:
- are there specific neural correlates for ageing effects on executive functioning (particularly inhibitory control) and decision-making?
- Is there a relationship, at the behavioral and neural levels, between ageing-related changes in executive functioning and decision-making?
Healthy participants will be recruited for
- a behavioral assessment including multiple tests of decision-making and executive functioning/inhibitory control;
- 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).
Results will provide an useful baseline for investigating alterations of decision-making and executive functioning, and of their neural bases, in pathological conditions.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All healthy participants | – | Other: No interventionAll healthy participants will undergo behavioral assessment and fMRI |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- 150 healty individuals, aged 18-60 years, sampled from the general population
Key inclusion criteria (2 listed)
- Healthy participants, as determined by screening assessments and principal investigator judgment
- The participant must be able to comply with study requirements as judged by the principal investigator
Key exclusion criteria (3 listed)
- Any history of alcohol and/or drug abuse, addiction or suspicion of regular consumption of drugs of abuse
- Use of any psychoactive medication, or medications known to have effect on central nervous system (CNS) or blood flow
- Any contraindications for magnetic resonance imaging (MRI) scans or any brain/head abnormalities restricting MRI eligibility
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 |
|---|---|---|
| No interventionNo intervention | Other | All healthy participants |
Primary outcome
Behavioral performance 1: Decision-making skills
Time frame: MRI-acquisition day 1
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
3 secondary outcomes
Behavioral performance 2: Executive functioning skills
Time frame: MRI-acquisition day 1
Brain activity underlying decision-making and executive performance
Time frame: MRI-acquisition day 1
Brain structure related to decision-making and executive performance
Time frame: MRI-acquisition day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Undecided. Requests for sharing will assessed case by case, and data will be made available on reasonable request.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 8 May 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral performance 1: Decision-making skills (time frame: MRI-acquisition day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2026.