Verticality Perception in Healthy Human SubjectsNCT02212704
Verticality Perception - Multisensory Contribution
A study testing Vestibular stimulation by use of the turntable (static roll-tilt while the head is roll-tilted relative to the trunk), 3D-video-head impulse testing and Vestibular-evoked myogenic potentials (VEMPs) in people with Verticality Perception in Healthy Human Subjects and Individual Contribution of Different Sensory Systems, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to evaluate the relative contribution of head- and trunk-based sensory systems to internal estimates of direction of gravity in healthy human subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Verticality Perception in Healthy Human Subjects, Individual Contribution of Different Sensory Systems
- What is being tested?
- Vestibular stimulation by use of the turntable (static roll-tilt while the head is roll-tilted relative to the trunk), 3D-video-head impulse testing and Vestibular-evoked myogenic potentials (VEMPs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2014to Nov 2015
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ages 18-60 years
- informed consent
- absence of exclusion criteria
Who cannot join
- peripheral-vestibular deficit
- disturbed consciousness
- history of sensory deficits
- visual field deficits
- other neurological or systemic disorder which can cause dementia or cognitive dysfunction
- intake of antidepressants, sedatives, or neuroleptics
- pregnancy, unless excluded by a negative pregnancy test
- known neck pain or status post neck trauma
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Dept. of Neurology
Zurich, Canton of Zurich, 8091
About this study
Official title: Verticality Perception - Dissociating Head and Trunk Contributors in Healthy Human Subjects
The purpose of this study is to evaluate the relative contribution of head- and trunk-based sensory systems to internal estimates of direction of gravity in healthy human subjects. To implement this assessment experimentally, the investigators will use a motor-driven 3D-turntable and a thermoplastic mask to keep the head in a stable, either roll-tilted (±30°) or aligned with the trunk. The investigators will then obtain measurements of the subjective visual vertical in seven different whole-body roll positions (max. 90° roll-tilt). Analysis will be driven by a state-of-the art Bayesian integration model. The investigators hypothesize that different sensory input signals are combined in a statistically optimal fashion.
- Conditions
- Verticality Perception in Healthy Human Subjects, Individual Contribution of Different Sensory Systems
- Being tested
- Vestibular stimulation by use of the turntable (static roll-tilt while the head is roll-tilted relative to the trunk), 3D-video-head impulse testing, Vestibular-evoked myogenic potentials (VEMPs)
- Keywords
- vestibular, proprioception, spatial orientation, bayesian
- Medical subject headings
- Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular stimulation by use of the turntable (static roll-tilt while the head is roll-tilted relative to the trunk)Other
3D-video-head impulse testingOther
Evaluation of semicircular canal function. This intervention is part of the screening to determine suitability for this study
Vestibular-evoked myogenic potentials (VEMPs)Other
Evaluation of otolith function. This intervention is part of the screening to determine suitability for this study
| Study group | Role | What they receive |
|---|---|---|
| Vestibular stimulation | Experimental | This is the experimental paradigm applied in all participants Receives: Other: Vestibular stimulation by use of the turntable (static roll-tilt while the head is roll-tilted relative to the trunk); Other: 3D-video-head impulse testing; Other: Vestibular-evoked myogenic potentials (VEMPs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy and precision of SVV adjustments in different head and trunk roll-tilt positions
Measured: During the turntable measurement (90 minutes)
Secondary outcomes (1)
relative contribution of head- and trunk-based sensory systems based on Bayesian modelling
Measured: while on the turntable (1.5 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Verticality Perception in Healthy Human SubjectsStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominik Straumann, Prof, MD, Principal investigator, University Hospital Zurich, Dept. of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212704
- Sponsor's protocol ID
- perception_head_roll_zurich
- Status last verified
- Oct 2024
- First submitted
- 6 Aug 2014
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verticality Perception - Dissociating Head and Trunk Contributors in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT02212704
- Acronym / sponsor ID
- perception_head_roll_zurich
- Conditions
- Verticality Perception in Healthy Human Subjects, Individual Contribution of Different Sensory Systems
- Keywords
- vestibular, proprioception, spatial orientation, bayesian
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 8 Aug 2014 (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.
The purpose of this study is to evaluate the relative contribution of head- and trunk-based sensory systems to internal estimates of direction of gravity in healthy human subjects. To implement this assessment experimentally, the investigators will use a motor-driven 3D-turntable and a thermoplastic mask to keep the head in a stable, either roll-tilted (±30°) or aligned with the trunk. The investigators will then obtain measurements of the subjective visual vertical in seven different whole-body roll positions (max. 90° roll-tilt). Analysis will be driven by a state-of-the art Bayesian integration model. The investigators hypothesize that different sensory input signals are combined in a statistically optimal fashion.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vestibular stimulation | Experimental | Other: Vestibular stimulation by use of the turntable (static roll-tilt while the head is roll-tilted relative to the trunk), Other: 3D-video-head impulse testing, Other: Vestibular-evoked myogenic potentials (VEMPs)This is the experimental paradigm applied in all participants |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ages 18-60 years
- informed consent
- absence of exclusion criteria
Key exclusion criteria (8 listed)
- peripheral-vestibular deficit
- disturbed consciousness
- history of sensory deficits
- visual field deficits
- other neurological or systemic disorder which can cause dementia or cognitive dysfunction
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 |
|---|---|---|
| Vestibular stimulation by use of the turntable (static roll-tilt while the head is roll-tilted relative to the trunk) | Other | Vestibular stimulation |
| 3D-video-head impulse testingEvaluation of semicircular canal function. This intervention is part of the screening to determine suitability for this study | Other | Vestibular stimulation |
| Vestibular-evoked myogenic potentials (VEMPs)Evaluation of otolith function. This intervention is part of the screening to determine suitability for this study | Other | Vestibular stimulation |
Primary outcome
Accuracy and precision of SVV adjustments in different head and trunk roll-tilt positions
Time frame: During the turntable measurement (90 minutes)
1 secondary outcome
relative contribution of head- and trunk-based sensory systems based on Bayesian modelling
Time frame: while on the turntable (1.5 hours)
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 1 Nov 2024.
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.
Dominik Straumann, Prof, MD principal investigator
University Hospital Zurich, Dept. of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular stimulation by use of the turntable (static roll-tilt while the head is roll-tilted relative to the trunk), 3D-video-head impulse testing and Vestibular-evoked myogenic potentials (VEMPs) in people with Verticality Perception in Healthy Human Subjects and Individual Contribution of Different Sensory Systems, run by University of Zurich 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 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 1 Nov 2024. 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?
Accuracy and precision of SVV adjustments in different head and trunk roll-tilt positions (time frame: During the turntable measurement (90 minutes)). 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 1 Nov 2024.