Neural Bases of Decision-making in Healthy Individuals

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:

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• Italy
  • Ita
    • Pavia, Ita, Italy, 27100
      • Recruiting
      • Istituti Clinici Scientifici Maugeri SpA
      • Contact: Tiziana Bachetti; Phone Number: +390382593210; Email: tiziana.bachetti@icsmaugeri.it
      • Principal Investigator: Nicola Canessa, PhD
      • Contact: Nicola Canessa, Canessa; Phone Number: +390382375845; Email: nicola.canessa@icsmaugeri.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

150 healty individuals, aged 18-60 years, sampled from the general population

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All healthy participants; All healthy participants will undergo behavioral assessment and fMRI	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	MRI-acquisition day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	MRI-acquisition day 1

Collaborators and Investigators

• Sponsor: Istituti Clinici Scientifici Maugeri SpA
• Collaborators: Istituto Universitario di Studi Superiori Pavia

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2018
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: fMRI; ageing; executive functioning; decision-making
• Other Study ID Numbers: 2137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Requests for sharing will assessed case by case, and data will be made available on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No