- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05164991
Visuo-Tactile Integration and Body Ownership in the Human Brain
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Zurich, Switzerland, 8008
- ETH Zurich, Rehabilitation Engeineering Laboratory
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MR imaging
The experiment is aimed to induce a virtual rubber hand illusion, in which the individuals can potentially experience an embodiment illusion
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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Analysis of objective measures of the RHI
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Through study completion, an average of 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Subjective Experience via VAS scale
Time Frame: Through study completion, an average of 2 years
|
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
|
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Automatic response (skin conductance)
Time Frame: Through study completion, an average of 2 years
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Silvio Ionta, Professor, Fondation Asile des Aveugles, 1002, Lausanne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021-0111
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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