Neural Bases of Social Cognitive Processing in Healthy Individuals

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05774860
• Other study ID #: 2197
• Status: Recruiting
• Start date: July 14, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Italy	Istituti Clinici Scientifici Maugeri SpA	Pavia	Ita

Sponsors (2)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA	Istituto Universitario di Studi Superiori Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Behavioral-study day 1
Secondary	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	Behavioral-study day 1
Secondary	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)	Behavioral-study day 1