Focus of Study: Higher Cognition and the Vestibular SystemNCT02979314
The Influence of GVS on Mental Transformation
A study testing Galvanic Vestibular Stimulation in people with Focus of Study: Higher Cognition and the Vestibular System, run by University of Zurich.
Trial summary
Corroboratory behavioral evidence showed interaction effects between vestibular stimulation and egocentric transformation. The investigators here examine in healthy participants, whether there are shared brain mechanisms underlying galvanic vestibular stimulation, illusory self-motion and egocentric transformation, as… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Focus of Study: Higher Cognition and the Vestibular System
- What is being tested?
- Galvanic Vestibular Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 26 May 2017
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Written informed consent by the participant
- Right handed
Who cannot join
- possession of metallic implants, cardiac pacemakers, neuro-stimulators, metal splinter injuries
- claustrophobia
- no ability to lie still in the scanner, e.g. a cold leading to frequent sneezing and subsequent head movements
- history of neurological or psychiatric disorder
- hearing problems
- concomitant medication
- strong motion sensitivity
- vestibular deficits
About this study
Official title: Overlapping Cortical Networks of Illusory and Mental Body Transformations
Corroboratory behavioral evidence showed interaction effects between vestibular stimulation and egocentric transformation.
The investigators here examine in healthy participants, whether there are shared brain mechanisms underlying galvanic vestibular stimulation, illusory self-motion and egocentric transformation, as well as their interaction.
It is hypothesized that the GVS induced illusory self-motion dampens the ability to perform egocentric mental transformation.
Read the detailed description
Theories of embodied mental rotation suggest overlapping processes between real body and egocentric mental transformations. Corroboratory behavioral evidence showed interaction effects between vestibular stimulation and egocentric transformation. Yet, no study so far has investigated which cortical areas are involved in vestibular processing and/or illusory self-motion and mental transformation tasks within the same participants. This however seems crucial, as important individual differences exist for both mental transformation abilities as well as in subjective perception of artificial vestibular stimulation.
The primary objective is to reveal which brain area(s) are involved in the interaction of illusory self-motion (as induced by galvanic vestibular stimulation (GVS)) and egocentric mental transformation, as compared to no illusory self-motion or object-based mental transformation. It is hypothesized that the GVS induced illusory self-motion dampens the ability to perform egocentric mental transformation more than object-based mental transformation.
As previous behavioral studies on such an interaction were always done in a sitting position, a secondary objective is to first replicate previous behavioral mental rotation studies that used GVS, in the Magnetic Resonance (MR) -scanner comparable setting. Moreover, as no brain imaging study so far has investigated subjective illusory motion experience induced by GVS, illusory self-motion will be measured and included in the statistical model to find specific brain regions modulating the illusory self-motion perception.
- Being tested
- Galvanic Vestibular Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galvanic Vestibular StimulationDevice
The investigators aim to study the influence of Galvanic Vestibular Stimulation on the brain mechanisms underlying illusory self-motion and its influence on egocentric mental transformation. As a control condition sham stimulation will be applied by the same device within the same participants in different trials. Participants should not note the difference.
| Study group | Role | What they receive |
|---|---|---|
| Galvanic Vestibular Stimulation | Experimental | A standard placement of the electrodes will be used for GVS and sham, placed on the mastoids. Weak currents up to maximally 3 mA will be used (tested before in each participant individually, and expected mean current will be around 1.5 mA). Previous studies have used Magnetic Resonance (MR) compatible GVS without reporting any discomfort for the participants, however weak sensations of nausea could be possible and in case that they are disturbing for the participants the experiment will be aborted. Continuous stimulation for up to 30min with intensities of 1-1.5 mA is generally considered as safe and free of any considerable side effects. Receives: Device: Galvanic Vestibular Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Oxygen-Level Dependent (BOLD) -signal change in response to egocentric mental transformation
The Relative BOLD-signal change in response to egocentric mental transformation during GVS versus mental transformation during sham stimulation will be measured in an functional Magnetic Resonance Imaging (fMRI) paradigm
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study start1 Dec 2016
- Primary completion26 May 2017
- Study completion26 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of Study: Higher Cognition and the Vestibular SystemStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Michels, MD, Principal investigator, University Hospital Zurich, Div. of Neuroradiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979314
- Sponsor's protocol ID
- 2016-00464
- Other IDs
- 2016
- Status last verified
- Oct 2018
- First submitted
- 23 Aug 2016
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overlapping Cortical Networks of Illusory and Mental Body Transformations
- ClinicalTrials.gov ID
- NCT02979314
- Acronym / sponsor ID
- 2016-00464
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 26 May 2017 (actual)
- Study completion
- 26 May 2017 (actual)
- First posted
- 1 Dec 2016 (estimated)
- 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.
Corroboratory behavioral evidence showed interaction effects between vestibular stimulation and egocentric transformation.
The investigators here examine in healthy participants, whether there are shared brain mechanisms underlying galvanic vestibular stimulation, illusory self-motion and egocentric transformation, as well as their interaction.
It is hypothesized that the GVS induced illusory self-motion dampens the ability to perform egocentric mental transformation.
Detailed description
Theories of embodied mental rotation suggest overlapping processes between real body and egocentric mental transformations. Corroboratory behavioral evidence showed interaction effects between vestibular stimulation and egocentric transformation. Yet, no study so far has investigated which cortical areas are involved in vestibular processing and/or illusory self-motion and mental transformation tasks within the same participants. This however seems crucial, as important individual differences exist for both mental transformation abilities as well as in subjective perception of artificial vestibular stimulation.
The primary objective is to reveal which brain area(s) are involved in the interaction of illusory self-motion (as induced by galvanic vestibular stimulation (GVS)) and egocentric mental transformation, as compared to no illusory self-motion or object-based mental transformation. It is hypothesized that the GVS induced illusory self-motion dampens the ability to perform egocentric mental transformation more than object-based mental transformation.
As previous behavioral studies on such an interaction were always done in a sitting position, a secondary objective is to first replicate previous behavioral mental rotation studies that used GVS, in the Magnetic Resonance (MR) -scanner comparable setting. Moreover, as no brain imaging study so far has investigated subjective illusory motion experience induced by GVS, illusory self-motion will be measured and included in the statistical model to find specific brain regions modulating the illusory self-motion perception.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Galvanic Vestibular Stimulation | Experimental | Device: Galvanic Vestibular StimulationA standard placement of the electrodes will be used for GVS and sham, placed on the mastoids. Weak currents up to maximally 3 mA will be used (tested before in each participant individually, and expected mean current will be around 1.5 mA). Previous studies have used Magnetic Resonance (MR) compatible GVS without reporting any discomfort for the participants, however weak sensations of nausea could be possible and in case that they are disturbing for the participants the experiment will be aborted. Continuous stimulation for up to 30min with intensities of 1-1.5 mA is generally considered as safe and free of any considerable side effects. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- Written informed consent by the participant
- Right handed
Key exclusion criteria (8 listed)
- possession of metallic implants, cardiac pacemakers, neuro-stimulators, metal splinter injuries
- claustrophobia
- no ability to lie still in the scanner, e.g. a cold leading to frequent sneezing and subsequent head movements
- history of neurological or psychiatric disorder
- hearing problems
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 |
|---|---|---|
| Galvanic Vestibular StimulationThe investigators aim to study the influence of Galvanic Vestibular Stimulation on the brain mechanisms underlying illusory self-motion and its influence on egocentric mental transformation. As a control condition sham stimulation will be applied by the same device within the same participants in different trials. Participants should not note the difference. | Device | Galvanic Vestibular Stimulation |
Primary outcome
Blood Oxygen-Level Dependent (BOLD) -signal change in response to egocentric mental transformation
Time frame: one day
The Relative BOLD-signal change in response to egocentric mental transformation during GVS versus mental transformation during sham stimulation will be measured in an functional Magnetic Resonance Imaging (fMRI) paradigm
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 31 Oct 2018.
- Individual participant dataSharing planned: Undecided
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.
Lars Michels, MD principal investigator
University Hospital Zurich, Div. of Neuroradiology
Questions about this trial
What is this clinical trial studying?
A study testing Galvanic Vestibular Stimulation in people with Focus of Study: Higher Cognition and the Vestibular System, run by University of Zurich.
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 8 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 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Blood Oxygen-Level Dependent (BOLD) -signal change in response to egocentric mental transformation (time frame: one day). 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 Oct 2018.