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
1 other identifier
observational
150
1 country
1
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?
- 3.a behavioral assessment including multiple tests of decision-making and executive functioning/inhibitory control;
- 4.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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 10, 2018
CompletedFirst Submitted
Initial submission to the registry
March 7, 2023
CompletedFirst Posted
Study publicly available on registry
March 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
April 8, 2026
April 1, 2025
8.5 years
March 7, 2023
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Behavioral performance 2: Executive functioning skills
MRI-acquisition day 1
Brain activity underlying decision-making and executive performance
MRI-acquisition day 1
Brain structure related to decision-making and executive performance
MRI-acquisition day 1
Study Arms (1)
All healthy participants
All healthy participants will undergo behavioral assessment and fMRI
Interventions
Eligibility Criteria
150 healty individuals, aged 18-60 years, sampled from the general population
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istituti Clinici Scientifici Maugeri SpA
Pavia, Ita, 27100, Italy
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2023
First Posted
March 20, 2023
Study Start
November 10, 2018
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
October 31, 2027
Last Updated
April 8, 2026
Record last verified: 2025-04