NeuroscienceOMNIBUS2023NCT06251479
Study of the Dynamics of Verbal and Non-verbal Interaction in Healthy Subjects, Through the Recording of Body Movements and Non-invasive Neurophysiological Techniques
A study testing behavioral 1, behavioral 2 and neuromodulation 1 in people with Neuroscience and Neuromodulation, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuroscience, Neuromodulation
- What is being tested?
- behavioral 1, behavioral 2 and neuromodulation 1
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 16 Aug 2023to 16 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range between 18 and 55 years
- written informed consent
- healthy subjects
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Centro Neurolesi Bonino Pulejo
Messina, Messina, 98124
Caterina Formica, PhD, PSY, +3909060128185, katia.formica@irccsme.it
About this study
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.
Read the 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.
- 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.
- 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.
- the investigators intend to study how the interactive context influences the cerebral and cortico-muscular oscillatory dynamics during the preparation of the action.
- 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
- Conditions
- Neuroscience, Neuromodulation
- Being tested
- behavioral 1, behavioral 2, neuromodulation 1, neuromodulation 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral 1Behavioural
verbal and non verbal tasks
behavioral 2Behavioural
verbal and non verbal tasks with other partecipants
neuromodulation 1Device
registration with neurophysiological tecniques during verbal and non verbal tasks
neuromodulation 2Device
registration with neurophysiological tecniques during verbal and non verbal tasks with other partecipants
| Study group | Role | What they receive |
|---|---|---|
| A group behavioral 1 | Experimental | The first group will perform perceptual and verbal and non-verbal motor execution tasks, while behavioral measurement techniques will be used. Receives: Behavioral: behavioral 1 |
| B group behavioral 2 | Experimental | 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. Receives: Behavioral: behavioral 2 |
| C group neuromoulation 1 | Experimental | The third group is identical to group A except that neurophysiological measurement techniques will also be applied. Receives: Device: neuromodulation 1 |
| D group neuromodulation 2 | Experimental | The fourth group is identical to group B except that neurophysiological measurement techniques will also be applied. Receives: Device: neuromodulation 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour
Secondary outcomes (1)
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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start16 Aug 2023
- Primary completion28 Dec 2023
- Study completion16 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroscienceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caterina Formica, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251479
- Sponsor's protocol ID
- OMNIBUS2023
- Acronym
- OMNIBUS2023
- Status last verified
- Mar 2026
- First submitted
- 28 Dec 2023
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Dynamics of Verbal and Non-verbal Interaction in Healthy Subjects, Through the Recording of Body Movements and Non-invasive Neurophysiological Techniques
- ClinicalTrials.gov ID
- NCT06251479
- Acronym / sponsor ID
- OMNIBUS2023 / OMNIBUS2023
- Conditions
- Neuroscience, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 16 Aug 2026 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
- 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.
- the investigators intend to study how the interactive context influences the cerebral and cortico-muscular oscillatory dynamics during the preparation of the action.
- 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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A group behavioral 1 | Experimental | Behavioral: behavioral 1The first group will perform perceptual and verbal and non-verbal motor execution tasks, while behavioral measurement techniques will be used. |
| B group behavioral 2 | Experimental | Behavioral: behavioral 2The 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. |
| C group neuromoulation 1 | Experimental | Device: neuromodulation 1The third group is identical to group A except that neurophysiological measurement techniques will also be applied. |
| D group neuromodulation 2 | Experimental | Device: neuromodulation 2The fourth group is identical to group B except that neurophysiological measurement techniques will also be applied. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age range between 18 and 55 years
- written informed consent
- healthy subjects
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral 1verbal and non verbal tasks | Behavioural | A group behavioral 1 |
| behavioral 2verbal and non verbal tasks with other partecipants | Behavioural | B group behavioral 2 |
| neuromodulation 1registration with neurophysiological tecniques during verbal and non verbal tasks | Device | C group neuromoulation 1 |
| neuromodulation 2registration with neurophysiological tecniques during verbal and non verbal tasks with other partecipants | Device | D group neuromodulation 2 |
Primary outcome
Embodiment Scale
Time frame: 1 hour
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 secondary outcome
Embodiment Scale
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral 1, behavioral 2 and neuromodulation 1 in people with Neuroscience and Neuromodulation, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Embodiment Scale (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.