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Recruiting NCT05774834

Neural Bases of Decision-making in Healthy Individuals

Observational Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Non-interventional Functional Magnetic Resonance Imaging (fMRI) Study on the Neural Bases of Decision-making in Healthy Individuals

Overview

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.

Interventions

  • Other No intervention
    No intervention

Primary outcome measures

  • Behavioral performance 1: Decision-making skills [Time frame: MRI-acquisition day 1]
Secondary outcome measures (3)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Istituti Clinici Scientifici Maugeri SpA — Pavia

Identifiers

NCT: NCT05774834 · 2137

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗