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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05774847
Other study ID # 2138
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 24, 2021
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
Health authority
Study type Observational

Clinical Trial Summary

This behavioral study on healthy participants aims to provide a baseline reference for assessing alterations of decision-making performance in pathological conditions. To this purpose, this single center non-interventional behavioral study will assess the extent to which decision-making performance is affected by distinct experimental manipulations, as well as by ageing effects, in 200 healthy individuals. The main questions it aims to answer are: - to what extent is decision-making performance stable, within individuals, regardless of non-economic manipulations concerning stimuli perceptual features as well as type of processing and motor response required to participants? - are these manipulations additionally influenced by participants' age? Healthy participants will be recruited for distinct behavioral studies assessing the effects of the aforementioned manipulations of distinct metrics of decision-making performance, such as loss aversion, risk aversion, and delay discounting.


Description:

The fast growth of so-called Decision Neuroscience has clearly shown the implications of methods and results from behavioral economics as a potential bridge for translational research in neuro-psychiatric settings. The combination of behavioral and neural metrics allows to describe decision-making across multiple levels of explanation ranging from biological dispositions to contextual influences. To date, however, the translational implications of Decision Neuroscience are constrained by a relatively limited knowledge of the potential modulators of decision-making, which seem to include perceptual, cognitive and motor variables. In this regard, there is largely sparse evidence concerning the modulation of choices by highly different factors such as a) perceptual features of the stimuli (e.g., spatial distance between visually-presented potential gains and losses); b) type of processing required to participants (e.g., select vs. reject an option); c) type of motor response required to communicate the decision (e.g., press vs. release a button); d) subliminal vs. supraliminal perception of the stimuli. Moreover, there is evidence of ageing effects on decision-making, particularly when choice-related evaluations involve a trade-off between reward and risk. On this ground, this single center non-interventional behavioral study aims to investigate whether, and how, distinct well-established metrics of decision-making are influenced by the aforementioned factors. To this purpose, 200 healthy individuals will be recruited and assigned to different behavioral studies aimed to assess the effect of the aforementioned manipulations on well-established gambling tasks resulting in individual metrics of loss aversion (the tendency to prefer avoiding losses to acquiring equivalent gains), risk aversion (the preference for certain outcomes over probabilistic ones), and delay discounting (the decline in the present value of a reward with delay to its receipt). The results of this study are expected to provide a baseline reference for assessing alterations of decision-making performance in pathological conditions.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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 Individual index of loss aversion This variable reflect the spontaneous disposition to overweigh potential losses, compared with equivalent gains in decision-making, resulting in the tendency to avoid potential losses more than approach potential gains. Behavioral-study day 1
Secondary Individual index of risk aversion This variable reflect the spontaneous preference for certain, compared with probabilistic, outcomes, resulting in the tendency to avoid risky options regardless of their expected value. Behavioral-study day 1
Secondary Individual index of delay discounting This variable reflects the tendency to discount delayed utilities/rewards compared with immediate ones, resulting in choices driven by the impulsive search for immediate gains regardless of potential larger future outcomes. Behavioral-study day 1
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