Viewing Study NCT05774860



Ignite Creation Date: 2024-05-06 @ 6:45 PM
Last Modification Date: 2024-10-26 @ 2:54 PM
Study NCT ID: NCT05774860
Status: RECRUITING
Last Update Posted: 2024-04-09
First Post: 2023-03-07

Brief Title: Neural Bases of Social Cognitive Processing in Healthy Individuals
Sponsor: Istituti Clinici Scientifici Maugeri SpA
Organization: Istituti Clinici Scientifici Maugeri SpA

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: 2024-04
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 whetherhow 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 empathymentalizing

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 volumedensity 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 volumedensity and c brain structural connectivity diffusion weighted imaging Results from fMRI 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 andor pathological conditions

Study Oversight

Has Oversight DMC: None
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?: None