Behavior and Behavior MechanismsNCT05164991
Visuo-Tactile Integration and Body Ownership in the Human Brain
A study testing Visuo-tactile stimulations of the right hand in people with Behavior and Behavior Mechanisms and Body Representation, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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"). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior and Behavior Mechanisms, Body Representation
- What is being tested?
- Visuo-tactile stimulations of the right hand
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Jan 2022to 12 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- general health
- personal interest
- age between 18 and 55 years old
- fulfil standard guidelines for fMRI studies
Who cannot join
- history of seizures, epilepsy
- specific medications or treatment
- concomitant diseases (e.g. cardiopathy)
- pregnancy
- unexplained loss of consciousness
- chronic headaches
Show all 12Show fewer
- neurological illnesses
- head concussion,
- presence of metal in the neck or head
- implanted medical devices
- drug abuse
- inability to give consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
ETH Zurich, Rehabilitation Engeineering Laboratory
Zurich, 8008
About this study
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").
Read the detailed 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).
- Being tested
- Visuo-tactile stimulations of the right hand
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visuo-tactile stimulations of the right handBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MR imaging | Experimental | The experiment is aimed to induce a virtual rubber hand illusion, in which the individuals can potentially experience an embodiment illusion Receives: Behavioral: Visuo-tactile stimulations of the right hand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuro-behavioral changes associated with vision-dependent alterations of body ownership, measured via brain activity (fMRI)
Analysis of objective measures of the RHI
Measured: Through study completion, an average of 2 years
Secondary outcomes (2)
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
Measured: Through study completion, an average of 2 years
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.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start10 Jan 2022
- Primary completion1 Sep 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior and Behavior MechanismsStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Psychiatric University Hospital, Zurich, Eye Hospital Jules Gonin
- Responsible party
- Sponsor
- Investigators
- Silvio Ionta, Professor, Principal investigator, Fondation Asile des Aveugles, 1002, Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164991
- Sponsor's protocol ID
- 2021-0111
- Status last verified
- Sep 2023
- First submitted
- 29 Oct 2021
- Last updated
- 13 Sep 2023
- 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 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visuo-Tactile Integration and Body Ownership in the Human Brain
- ClinicalTrials.gov ID
- NCT05164991
- Acronym / sponsor ID
- 2021-0111
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Psychiatric University Hospital, Zurich, Eye Hospital Jules Gonin
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 21 Dec 2021 (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.
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").
Detailed 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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR imaging | Experimental | Behavioral: Visuo-tactile stimulations of the right handThe experiment is aimed to induce a virtual rubber hand illusion, in which the individuals can potentially experience an embodiment illusion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- general health
- personal interest
- age between 18 and 55 years old
- fulfil standard guidelines for fMRI studies
Key exclusion criteria (12 listed)
- history of seizures, epilepsy
- specific medications or treatment
- concomitant diseases (e.g. cardiopathy)
- pregnancy
- unexplained loss of consciousness
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 |
|---|---|---|
| Visuo-tactile stimulations of the right handParticipants 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. | Behavioural | MR imaging |
Primary outcome
Neuro-behavioral changes associated with vision-dependent alterations of body ownership, measured via brain activity (fMRI)
Time frame: Through study completion, an average of 2 years
Analysis of objective measures of the RHI
2 secondary outcomes
Subjective Experience via VAS scale
Time frame: Through study completion, an average of 2 years
Automatic response (skin conductance)
Time frame: Through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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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. This study is not recruiting at the moment.
Silvio Ionta, Professor principal investigator
Fondation Asile des Aveugles, 1002, Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visuo-tactile stimulations of the right hand in people with Behavior and Behavior Mechanisms and Body Representation, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 13 Sep 2023. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuro-behavioral changes associated with vision-dependent alterations of body ownership, measured via brain activity (fMRI) (time frame: Through study completion, an average of 2 years). 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 13 Sep 2023.