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Healthy VolunteersNCT05774860

Neural Bases of Social Cognitive Processing in Healthy Individuals

An observational study of Healthy Volunteers, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Healthy Volunteers
How many people
200 participants
Where
1 siteItaly
Study dates
14 Jul 2018to 31 Oct 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site, 1 recruiting
  • Istituti Clinici Scientifici Maugeri SpA

    Pavia, Ita, 27100

    Nicola Canessa, PhD, +390382375845, nicola.canessa@icsmaugeri.it

    Tiziana Bachetti, +390382593210, tiziana.bachetti@icsmaugeri.it

    Recruiting

Other trials in Italy

About this study

Official title: 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?
Read more

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.

Read the 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.

Being tested
No intervention
Keywords
social cognitive processing, empathy, mentalizing, fMRI, ageing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention

Study groups in NCT05774860
Study groupRoleWhat they receive
All healthy participantsAll healthy participants will undergo behavioral assessment and fMRI or EEG
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Behavioral-study day 1

Secondary outcomes (3)
  1. Behavioral performance 2: social cognitive skills

    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.

    Measured: Behavioral-study day 1

  2. Brain activity underlying social cognitive performance at high temporal resolution

    EEG task-related data showing the temporal development of the neural processes associated with performing social cognitive tasks

    Measured: Behavioral-study day 1

  3. Behavioral performance 1: empathy and mentalizing

    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)

    Measured: Behavioral-study day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2023
  2. Study start14 Jul 2018
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05774860
Sponsor's protocol ID
2197
Status last verified
Apr 2026
First submitted
7 Mar 2023
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Requests for sharing will assessed case by case, and data will be made available on reasonable request.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Volunteers, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain activity underlying social cognitive performance at high spatial resolution (time frame: Behavioral-study day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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