Neural Bases of Decision-making in Healthy Individuals

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05774834
• Other study ID #: 2137
• Status: Recruiting
• Start date: November 10, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Italy	Istituti Clinici Scientifici Maugeri SpA	Pavia	Ita

Sponsors (2)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA	Istituto Universitario di Studi Superiori Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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