VestibularNCT02760173
Verticality Perception - Effects of Prolonged Roll-tilt in Healthy Human Subjects
A study testing perception of vertical after static roll-tilt over 5min in people with Vestibular and Perception, run by University of Zurich.
Trial summary
The long-term goal of this research is to advance our knowledge of how the brain combines the information of multiple sensory systems coding for spatial orientation and how adaptation to vestibular imbalance influences spatial orientation. In healthy human subjects verticality perception is accurate while upright. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular, Perception
- What is being tested?
- perception of vertical after static roll-tilt over 5min
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 28 Jun 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ages 18-65 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
About this study
The long-term goal of this research is to advance our knowledge of how the brain combines the information of multiple sensory systems coding for spatial orientation and how adaptation to vestibular imbalance influences spatial orientation. In healthy human subjects verticality perception is accurate while upright. After prolonged roll-tilt, humans show a systematic bias in perceived direction towards the previous roll-tilted position (so-called "post-tilt bias"). Here we evaluate different potential explanations for this bias using both vision-dependent and vision-independent paradigms of verticality perception.
- Conditions
- Vestibular, Perception
- Being tested
- perception of vertical after static roll-tilt over 5min
- Keywords
- verticality perception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perception of vertical after static roll-tilt over 5minOther
subjects will indicate perceived direction of vertical after 5min of static whole-body roll-tilt.
| Study group | Role | What they receive |
|---|---|---|
| Single intervention arm | Experimental | This is the only arm in this study, measuring verticality perception after prolonged roll-tilt over 5min. Receives: Other: perception of vertical after static roll-tilt over 5min |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjustment errors and trial-to-trial variability as assessed by line adjustments (subjective visual vertical (SVV)), adjustments of a rod (subjective haptic vertical (SHV)) or self-adjustments (subjective postural vertical (SPV)) after prolonged roll
In all three paradigms (SVV, SHV and SPV) the percept of direction of gravity will be assessed. Parameters will be adjustment errors ("accuracy") and trial-to-trial variability ("precision") based on repetitive adjustments of a luminous line (SVV) or a rod (SHV) after returning to upright position after a period of 5min in static roll-tilt at 90° left-ear down or right-ear down. During the roll-tilt period subjects remain either in the dark or observe a rotating optokinetic (random dot) pattern. Individual mean values and standard deviation (SD) will be calculated for all conditions. Adjustments with the joystick (SPV) will start from 90° ear-down positions after 5min of static roll.
Measured: measurements will be obtained over periods of 5min in a single session and day
Secondary outcomes (1)
Impact of a rotating optokinetic stimulus (velocity 60°/s) on adjustment errors as assessed by the SVV, the SHV or the SPV after 5min of static roll-tilt at +/- 90° roll.
During the 5min period with static roll at +/- 90deg ear-down positions subjects will be presented a rotating optokinetic stimulus (random dot pattern, clockwise or counter-clockwise rotation) in some conditions. Adjustment errors and trial-to-trial variability of conditions with the optokinetic stimulus will be compared to those without the optokinetic stimulus.
Measured: measurements will be obtained over periods of 5min in a single session and day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study start1 Jun 2016
- Primary completion1 Jul 2016
- Study completion28 Jun 2018
Why it stopped: This protocol was re-written and resubmitted under a different trial number again (NCT02980419)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VestibularStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominik Straumann, MD, Principal investigator, University of Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760173
- Sponsor's protocol ID
- vert_perc_posttilt
- Status last verified
- Jun 2018
- First submitted
- 26 Apr 2016
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verticality Perception - Effects of Prolonged Roll-tilt in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT02760173
- Acronym / sponsor ID
- vert_perc_posttilt
- Conditions
- Vestibular, Perception
- Keywords
- verticality perception
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This protocol was re-written and resubmitted under a different trial number again (NCT02980419)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jun 2016
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 3 May 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.
The long-term goal of this research is to advance our knowledge of how the brain combines the information of multiple sensory systems coding for spatial orientation and how adaptation to vestibular imbalance influences spatial orientation. In healthy human subjects verticality perception is accurate while upright. After prolonged roll-tilt, humans show a systematic bias in perceived direction towards the previous roll-tilted position (so-called "post-tilt bias"). Here we evaluate different potential explanations for this bias using both vision-dependent and vision-independent paradigms of verticality 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 |
|---|---|---|
| Single intervention arm | Experimental | Other: perception of vertical after static roll-tilt over 5minThis is the only arm in this study, measuring verticality perception after prolonged roll-tilt over 5min. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ages 18-65 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 |
|---|---|---|
| perception of vertical after static roll-tilt over 5minsubjects will indicate perceived direction of vertical after 5min of static whole-body roll-tilt. | Other | Single intervention arm |
Primary outcome
Adjustment errors and trial-to-trial variability as assessed by line adjustments (subjective visual vertical (SVV)), adjustments of a rod (subjective haptic vertical (SHV)) or self-adjustments (subjective postural vertical (SPV)) after prolonged roll
Time frame: measurements will be obtained over periods of 5min in a single session and day
In all three paradigms (SVV, SHV and SPV) the percept of direction of gravity will be assessed. Parameters will be adjustment errors ("accuracy") and trial-to-trial variability ("precision") based on repetitive adjustments of a luminous line (SVV) or a rod (SHV) after returning to upright position after a period of 5min in static roll-tilt at 90° left-ear down or right-ear down. During the roll-tilt period subjects remain either in the dark or observe a rotating optokinetic (random dot) pattern. Individual mean values and standard deviation (SD) will be calculated for all conditions. Adjustments with the joystick (SPV) will start from 90° ear-down positions after 5min of static roll.
1 secondary outcome
Impact of a rotating optokinetic stimulus (velocity 60°/s) on adjustment errors as assessed by the SVV, the SHV or the SPV after 5min of static roll-tilt at +/- 90° roll.
Time frame: measurements will be obtained over periods of 5min in a single session and day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Dominik Straumann, MD principal investigator
University of Zurich, Switzerland
Questions about this trial
What is this clinical trial studying?
A study testing perception of vertical after static roll-tilt over 5min in people with Vestibular and Perception, 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: withdrawn, as of the sponsor's last update on 2 Jul 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 was withdrawn before enrolling participants, so there are no results.
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?
Adjustment errors and trial-to-trial variability as assessed by line adjustments (subjective visual vertical (SVV)), adjustments of a rod (subjective haptic vertical (SHV)) or self-adjustments (subjective postural vertical (SPV)) after prolonged roll (time frame: measurements will be obtained over periods of 5min in a single session and 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 2 Jul 2018.