Neural Bases of Social Cognitive Processing in Healthy Individuals
ConditionHealthy Volunteers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorIstituti Clinici Scientifici Maugeri SpA
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 population
200 healty individuals, aged 18-60 years, sampled from the general population
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionNo intervention
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: All healthy participants1 intervention
Trial outcomes
Primary outcomes
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
Time frame
Behavioral-study day 1Secondary outcomes
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.
Time frame
Behavioral-study day 12
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
Time frame
Behavioral-study day 13
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)
Time frame
Behavioral-study day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Istituti Clinici Scientifici Maugeri SpA
Lead sponsor
Istituto Universitario di Studi Superiori Pavia
Collaborator
Source ClinicalTrials.gov