Neural Bases of Social Cognitive Processing in Healthy Individuals

NCT05774860 | Recruiting

• 1 other identifier: 2197
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

social cognitive processing; empathy; mentalizing; fMRI; ageing

Outcome Measures

Primary Outcomes (1)

• Brain activity underlying social cognitive performance at high spatial resolution

  fMRI task-related data showing regional changes of brain activity associated with performing social cognitive tasks

  Behavioral-study day 1

Secondary Outcomes (3)

• Behavioral performance 2: social cognitive skills

  Behavioral-study day 1

• Brain activity underlying social cognitive performance at high temporal resolution

  Behavioral-study day 1

• Behavioral performance 1: empathy and mentalizing

  Behavioral-study day 1

Study Arms (1)

All healthy participants

All healthy participants will undergo behavioral assessment and fMRI or EEG

Other: No intervention

Interventions

No intervention OTHER

No intervention

All healthy participants

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

200 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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• Istituto Universitario di Studi Superiori Pavia: collaborator

Study Sites (1)

Istituti Clinici Scientifici Maugeri SpA

Pavia, Ita, 27100, Italy

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: July 14, 2018
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 8, 2026

Record last verified: 2025-04

Locations

IT (1)