RecruitingNot Applicable

Neural Bases of Social Cognitive Processing in Healthy Individuals

Italy200 participantsStarted 2018-07-14

Plain-language summary

The goal of this single center non-interventional fMRI and EEG study is to assess the neural bases of social cognitive processing in healthy individuals, and whether/how their responsiveness is modulated by ageing. The main questions it aims to answer are: * are there specific brain regions where individual differences in social cognitive performance reflect well-established metrics of social cogntion such as empathy and mentalizing? * is there a relationship, at the behavioral and neural levels, between ageing-related changes in social cognitive performance and empathy/mentalizing? Healthy participants will be recruited for: * a behavioral assessment including multiple tests of social cognition focused on empathy and mentalizing; * for half participants: a fMRI session to collect data concerning a) brain activity associated with action observation and social cognitive processing, b) brain structural morphometriy (grey-matter volume/density), and c) brain structural connectivity (diffusion weighted imaging) * for half participants: a EEG session to collect data concerning brain responsiveness to social cognitive processing with higher temporal resolution than that afforded by fMRI. Results will provide an useful baseline for investigating alterations of social cognitive processing, and of their neural bases, in pathological conditions.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Brain activity underlying social cognitive performance at high spatial resolution

Timeframe: Behavioral-study day 1

Trial details

NCT IDNCT05774860

SponsorIstituti Clinici Scientifici Maugeri SpA

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-04-30

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