NCT05774834

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. 1.are there specific neural correlates for ageing effects on executive functioning (particularly inhibitory control) and decision-making?
  2. 2.Is there a relationship, at the behavioral and neural levels, between ageing-related changes in executive functioning and decision-making?
  3. 3.a behavioral assessment including multiple tests of decision-making and executive functioning/inhibitory control;
  4. 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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Nov 2018Oct 2027

Study Start

First participant enrolled

November 10, 2018

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

April 8, 2026

Status Verified

April 1, 2025

Enrollment Period

8.5 years

First QC Date

March 7, 2023

Last Update Submit

April 7, 2026

Conditions

Keywords

decision-makingexecutive functioningfMRIageing

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

Other: No intervention

Interventions

No intervention

All healthy participants

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

RECRUITING

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

Locations