Clinical trial NCT05774834: Neural Bases of Decision-making in Healthy Individuals
Official title: A Non-interventional Functional Magnetic Resonance Imaging (fMRI) Study on the Neural Bases of Decision-making in Healthy Individuals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy Volunteers
Keywords: decision-making
executive functioning
fMRI
ageing
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
Collaborators: name: Istituto Universitario di Studi Superiori Pavia
First posted: 2023-03-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 150 healty individuals, aged 18-60 years, sampled from the general population

Brief 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. are there specific neural correlates for ageing effects on executive functioning (particularly inhibitory control) and decision-making?
2. 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

1. a behavioral assessment including multiple tests of decision-making and executive functioning/inhibitory control;
2. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Behavioral performance 1: Decision-making skills
timeFrame: MRI-acquisition day 1
Secondary outcomes:
measure: Behavioral performance 2: Executive functioning skills
timeFrame: MRI-acquisition day 1
measure: Brain activity underlying decision-making and executive performance
timeFrame: MRI-acquisition day 1
measure: Brain structure related to decision-making and executive performance
timeFrame: MRI-acquisition day 1
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri SpA
state: Ita
Study officials:
References: