Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-28 @ 8:13 PM
Study NCT ID:
NCT05774860
Status:
RECRUITING
Last Update Posted:
2025-04-11
First Post:
2023-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neural Bases of Social Cognitive Processing in Healthy Individuals
Sponsor:
Istituti Clinici Scientifici Maugeri SpA
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: