Study of the Dynamics of Verbal and Non-verbal Interaction in Healthy Subjects, Through the Recording of Body Movements and Non-invasive Neurophysiological Techniques (OMNIBUS2023)

Based on study literature, the investigators can say that our study aims to give an explanation not only from a behavioral point of view but also with respect to what are the neuronal mechanisms underlying our ability to perceive and analyze our own and others' actions. This is essential to fully understand the complexity of our social behaviors. The knowledge of these mechanisms has a high value and relevant implications for many research fields both within and outside the neurosciences. The project aims to study the neurobehavioral correlates of verbal and non-verbal communication. Through the use of non-invasive behavioral and neurophysiological techniques, the study intends to highlight the neurobehavioral markers that allow to quantify the temporal evolution of communication dynamics in healthy subjects.

Study Overview

• Status: Recruiting
• Conditions: Neuromodulation; Neuroscience
• Intervention / Treatment: Behavioral: behavioral 1; Behavioral: behavioral 2; Device: neuromodulation 1; Device: neuromodulation 2

Detailed Description

Based on study literature, the investigators can say that our study aims to give an explanation not only from a behavioral point of view but also with respect to what are the neuronal mechanisms underlying our ability to perceive and analyze our own and others' actions. This is essential to fully understand the complexity of our social behaviors. The knowledge of these mechanisms has a high value and relevant implications for many research fields both within and outside the neurosciences. The project aims to study the neurobehavioral correlates of verbal and non-verbal communication. Through the use of non-invasive behavioral and neurophysiological techniques, the study intends to highlight the neurobehavioral markers that allow to quantify the temporal evolution of communication dynamics in healthy subjects.

1. the investigators intend to verify whether individual differences in the ability to discriminate the verbal and non-verbal signals of others are reflected in significant differences in the way the same actions are performed.
2. the investigators intend to quantify the behavioral variables during the execution of the action and observe how these are modified in the passage from a single execution to an interaction context.
3. the investigators intend to study how the interactive context influences the cerebral and cortico-muscular oscillatory dynamics during the preparation of the action.
4. the investigators intend to verify whether the activity of the motor system contributes not only to the execution of the action but also, if and, if so, to the perception of the actions of others

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Messina, Italy, 98124
    • Recruiting
    • Irccs Centro Neurolesi Bonino Pulejo
    • Contact: Caterina Formica, PhD, PSY; Phone Number: +3909060128185; Email: katia.formica@irccsme.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age range between 18 and 55 years
• written informed consent
• healthy subjects

Exclusion Criteria:

• epilepsy or at risk of epileptic seizures,
• cardiac pacemaker wearers,
• presence of an implanted infusion pump,
• metal plaques in the skull or metal objects in the eye and skull taking neuroleptic drugs or tricyclic antidepressants,
• migraine or at risk of developing this disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A group behavioral 1; The first group will perform perceptual and verbal and non-verbal motor execution tasks, while behavioral measurement techniques will be used.	Behavioral: behavioral 1; verbal and non verbal tasks
Experimental: B group behavioral 2; The second group will perform the same tasks as group A and will be subjected to the same measurements as group A. Differently from group A, the members of group B will perform the experimental tasks together with another participant.	Behavioral: behavioral 2; verbal and non verbal tasks with other partecipants
Experimental: C group neuromoulation 1; The third group is identical to group A except that neurophysiological measurement techniques will also be applied.	Device: neuromodulation 1; registration with neurophysiological tecniques during verbal and non verbal tasks
Experimental: D group neuromodulation 2; The fourth group is identical to group B except that neurophysiological measurement techniques will also be applied.	Device: neuromodulation 2; registration with neurophysiological tecniques during verbal and non verbal tasks with other partecipants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Embodiment Scale	patients have to experience rubber hand illusion first with a silicon and and second with a robotic hand. the embodiment variance is evaluted in the two condition with the embofiment scale	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Embodiment Scale	patients have to experience with a single-pulse Transcranial magnetic stimulation during seeing a visual cue where a human hand is stung. the questionnaire evalute the embodiment variance	1 hour

Collaborators and Investigators

• Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2023
• Primary Completion (Actual): December 28, 2023
• Study Completion (Estimated): August 16, 2026

Study Registration Dates

• First Submitted: December 28, 2023
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Estimated): February 9, 2024

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: OMNIBUS2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No