Neural Bases of Decision-making in Healthy Individuals
ConditionHealthy Volunteers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorIstituti Clinici Scientifici Maugeri SpA
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
150 healty individuals, aged 18-60 years, sampled from the general population
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
No intervention
Other interventionNo intervention
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: All healthy participants1 intervention
Trial outcomes
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
Time frame
MRI-acquisition day 1Secondary outcomes
1
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.
Time frame
MRI-acquisition day 12
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.
Time frame
MRI-acquisition day 13
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.
Time frame
MRI-acquisition day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Istituti Clinici Scientifici Maugeri SpA
Lead sponsor
Istituto Universitario di Studi Superiori Pavia
Collaborator
Source ClinicalTrials.gov