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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05164991
Other study ID # 2021-0111
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2022
Est. completion date September 12, 2023

Study information

Verified date September 2023
Source Swiss Federal Institute of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The present project exploits brain imaging and neuroscience robotics to investigate the role of quantifiable visual input on the relationship between visuo-tactile integration and body ownership (the feeling that "this" body belongs to "me").


Description:

Observational study, fundamental research, multicentric, national. The analysis of questionnaires, self-reports, and brain imaging associated with the RHI is used to understand the influence of visual input on body ownership. To this aim, participants lay down in the magnetic resonance (MR) scanner (Figure 1B), are presented with visual stimuli (videos of the virtual rubber hand - visual stroking) simultaneously in real time with tactile stimuli (robotic stroking of the participant's hand - tactile stroking), and in combination or not with the measurement of autonomic arousal (GSR) associated with the observation of a video showing the virtual rubber hand in a threatening situation (e.g. a knife approaching the virtual hand - unconscious RHI effects). By means of structured questionnaires and semi-structured self-reports, participants (i) evaluate eventual sensations felt during the visuo-tactile stimulation and (ii) report the personal feelings and impressions about body ownership for the virtual rubber hand (conscious RHI effects).


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date September 12, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - general health - personal interest - age between 18 and 55 years old - fulfil standard guidelines for fMRI studies Exclusion Criteria: - history of seizures, epilepsy - specific medications or treatment - concomitant diseases (e.g. cardiopathy) - pregnancy - unexplained loss of consciousness - chronic headaches - neurological illnesses - head concussion, - presence of metal in the neck or head - implanted medical devices - drug abuse - inability to give consent

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Visuo-tactile stimulations of the right hand
Participants lay down in the magnetic resonance (MR) scanner are presented with visual stimuli (videos of the virtual rubber hand - visual stroking) simultaneously in real time with tactile stimuli (robotic stroking of the participant's hand - tactile stroking). An MR-compatible robot systematically provides the tactile stroking on the participant's hand. MR-compatible goggles show the visual stroking. Patterns of long and short robotic movements will be provided.

Locations

Country Name City State
Switzerland ETH Zurich, Rehabilitation Engeineering Laboratory Zurich

Sponsors (3)

Lead Sponsor Collaborator
Swiss Federal Institute of Technology Eye Hospital Jules Gonin, Psychiatric University Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neuro-behavioral changes associated with vision-dependent alterations of body ownership, measured via brain activity (fMRI) Analysis of objective measures of the RHI Through study completion, an average of 2 years
Secondary Subjective Experience via VAS scale To understand the variations of the body ownership, Visual Analogic Scale, values 0 to 7, 0 = no illusory body ownership, 7 = strong illusory body ownership Through study completion, an average of 2 years
Secondary Automatic response (skin conductance) Measure of the skin conductance response (SCR, measured in siemens) during experiment runs, which is an indirect measure of sympathetic activity.
Compare the blocks in which a pre-recorded visual threat (a video in which a hand is being pricked by a syringe needle) with baseline blocks and expect a higher SCR signal during "visual threat" blocks compared to the baseline. The SCR will be measured through a device connected to a dedicated laptop and electrodes that will be attached to the left index and middle fingers from participants. The SCR will be saved in log files and estimated a posteriori for each block using a general linear model and the weight regressors will be compared. There are no risks to the participants (since it is a passive measurement) the electrodes are compatible to the magnetic resonance environment.
Through study completion, an average of 2 years
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