Neural Bases of Social Cognitive Processing in Healthy Individuals

May 4, 2026 updated by: Istituti Clinici Scientifici Maugeri SpA

A Non-interventional Functional Magnetic Resonance Imaging (fMRI) and ElectroEncephalography (EEG) Study on the Neural Bases of Social Cognitive Processing in Healthy Individuals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The translational implications of results from social cognitive neuroscience are largely based on the increasing awareness on the role played by the so-called mirror and mentalizing brain networks in understanding others' behaviors and in decoding their intentions and feelings. The evidence obtained so far on the "social brain" in healthy young individuals nowadays constitutes the baseline for detecting changes in social cognitive skills associated with physiological aging or pathological conditions. The translational implications of social neuroscience are however constrained by some crucial limitations in the existing literature, that the present study aims to address. First, most the available evidence in social neuroscience results from studies assessing brain responses to the processing of single, rather than interacting, individuals. Second, most of the available knowledge concerns brain responses associated with observing others' behavior, while it is much less clear to what extent the same, or others, areas of the "social brain" are also engaged by social-related linguistic stimuli. Finally, despite the increasing emphasis on the potentially protective role of social cognition in physiological ageing, there is only preliminary evidence on possible changes of such responses in elderly individuals. On this ground, this single center non-interventional study aims to extend the available knowledge on the neural bases of social cognitive processing in 200 healthy individuals who will undergo either fMRI or EEG in association with tasks involving either visual or linguistic social stimuli concerning single and interacting individuals. In the case of EEG, data related to changes in brain electrical activity will be recorded with 64 channels. As to MRI, a multimodal session will include data concerning a) brain activity associated with social cognitive processing, b) brain structural morphometry (grey-matter volume/density), and c) brain structural connectivity (diffusion weighted imaging). Results from (f)MRI and EEG will be additionally related to individual differences in social cognitive skills, as measured through a behavioral assessment involving key variables of social cognition such as empathy (with the Balanced Emotional Empathy Scale (BEES) and the Interpersonal reactivity Index (IRI)) and mentalizing (with the Story-Based-Empathy taks and the Yoni task). MRI data will unveil the neural bases of individual differences in social cognitive performance in terms of performance-related patterns of brain activity, structure and connectivity. EEG will complement this evidence via data characterized by higher temporal resolution, to unveil the temporal development of social cognitive processes in the brain. Results will provide an useful baseline for investigating alterations of social cognition in physiological ageing and/or pathological conditions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Ita
      • Pavia, Ita, Italy, 27100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

200 healty individuals, aged 18-60 years, sampled from the general population

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
All healthy participants
All healthy participants will undergo behavioral assessment and fMRI or EEG
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Brain activity underlying social cognitive performance at high spatial resolution
Time Frame: Behavioral-study day 1
fMRI task-related data showing regional changes of brain activity associated with performing social cognitive tasks
Behavioral-study day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Behavioral performance 2: social cognitive skills
Time Frame: Behavioral-study day 1
Participants' social cognitive skills will be assessed in terms of performance and response time in tasks requiring to process either visual or linguistic social (vs. individual) positively- and negatively-valenced stimuli inducing variable degree of arousal.
Behavioral-study day 1
Brain activity underlying social cognitive performance at high temporal resolution
Time Frame: Behavioral-study day 1
EEG task-related data showing the temporal development of the neural processes associated with performing social cognitive tasks
Behavioral-study day 1
Behavioral performance 1: empathy and mentalizing
Time Frame: Behavioral-study day 1
Participants' disposition towards social stimuli will be assessed in terms of well-know metrics such as affective empathy or cognitive empathy (as measures with the Balanced Emotional Empathy Scale (BEES) or the Interpersonal Reactivity Index (IRI)), or mentalizing (as measured with the Story-Based Empathy task)
Behavioral-study day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituti Clinici Scientifici Maugeri SpA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Istituto Universitario di Studi Superiori Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2197

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Requests for sharing will assessed case by case, and data will be made available on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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