Vestibular PerceptionNCT02212847
Spatial Orientation and Vestibular Function
A study testing vestibular stimulation in people with Vestibular Perception and Damaged Vestibular System, run by University of Zurich at 1 site in Switzerland.
Trial summary
Spatial orientation is achieved through central integration of various sensory inputs and prior knowledge in a statistically optimal way based on the reliability of the different signals. When upright, the subjective visual vertical (SVV) is accurate and precise in healthy human subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Perception, Damaged Vestibular System
- What is being tested?
- vestibular stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2013to 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ages 18-75
- informed consent
- for group 1: acute (i.e. symptom onset less than 72 hours ago) unilateral vestibular deficit as confirmed by clinical examination (pathologic head-impulse test, no skew deviation, no gaze-evoked nystagmus).
- for group 2: chronic (i.e. symptom onset more than 4 weeks ago) unilateral vestibular deficit as confirmed by vestibular testing in the acute stage (either abnormal unilateral response on caloric irrigation or video-head-impulse testing).
- for group 3: chronic (i.e. symptom onset more than 4 weeks ago) bilateral vestibular deficits as confirmed by vestibular testing (bilaterally reduced response on caloric irrigation or video-head impulse testing).
- absence of exclusion criteria
Who cannot join
- History of a peripheral-vestibular deficit (valid only for group 4 - controls)
- Disturbed consciousness
- Personal history of traumatic brain injury, cerebrovascular disorders, seizures
- History of chronic neck complaints including severe neck pain.
- Alcohol dependency
- Intake of anxiolytic, antidepressant, neuroleptic or sedative medication
- Other neurological or systemic disorder which can cause cerebellar deficits, dementia, cognitive dysfunction, visuospatial or tactile neglect, aphasia or visual field deficits
- Pregnancy or possible pregnancy if not ruled out by a negative pregnancy test.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Neurology
Zurich, Canton of Zurich, 8091
About this study
Official title: Spatial Orientation and Vestibular Function in Patients With Acute or Chronic Unilateral Vestibular Deficits and in Patients With Bilateral Vestibular Deficits
Spatial orientation is achieved through central integration of various sensory inputs and prior knowledge in a statistically optimal way based on the reliability of the different signals. When upright, the subjective visual vertical (SVV) is accurate and precise in healthy human subjects. However, when roll-tilted, both systematic physiologic, roll-angle dependent errors (termed A- und E-effect) and a decrease in precision of SVV estimates have been described. In case of a sudden unilateral vestibular deficit (UVD) a significant imbalance between the two vestibular organs occurs at the level of the vestibular nuclei, disrupting the percept of vertical. The most frequent cause for such a unilateral vestibular deficit is an inflammation of the vestibular nerve by viral infection, termed vestibular neuritis (VN). While in the acute stage these patients are usually immobilized due to the severity of symptoms, recovery is overall good and most patients return to their daily activities within a few weeks. Central compensation is considered the most important contributor to recovery in these patients, while recovery of the damaged vestibular nerve occurs only in a minority of cases. While acute VN presents with sudden UVD, bilateral vestibular deficits (BVD) typically evolve more slowly and re-sult in distinct complaints.
The percept of vertical can be quantified by assessing the subjective visual vertical or SVV, which is usually done by letting subjects adjust a luminous line along perceived direction of gravity. Modifications of this paradigm which are independent from retinal input are e.g. adjustments of a rod along perceived vertical in complete darkness (termed subjective haptic vertical or SHV) and self-alignments along perceived vertical (subjective postural vertical or SPV) and perceived horizontal (subjective postural horizontal or SPH) in complete darkness. Previous research has proposed no unified percept of vertical as errors assessed in different domains (visual, haptic, postural) were diverging in patients with acute UVD. While errors were profound for the SVV, the SPV remained accurate.
Here the investigators aim to quantify verticality perception in patients with either acute or chronic UVD and patients with BVD both in upright and roll-tilted positions. Specifically, the investigators will use different paradigms to address the ques-tion whether there is a unified percept of vertical and how a bias in this percept changes over time.
- Conditions
- Vestibular Perception, Damaged Vestibular System
- Being tested
- vestibular stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vestibular stimulationOther
| Study group | Role | What they receive |
|---|---|---|
| vestibular stimulation | Experimental | Not described Receives: Other: vestibular stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of verticality perception - baseline and change over 3 months
The accuracy of verticality perception is defined as the individual median value of a series of line adjustments along perceived direction of gravity (units: degrees). this results in a report of the participants perceived direction of gravity relative to true earth-vertical. Repetitive adjustments will be collected while on the turntable, each adjustment lasting up to 15seconds.
Measured: at baseline for the control group (while on the turntable over 1 hour) and change from baseline to follow-up after 3 months for the acute vestibular loss group (again over 1 hour)
Secondary outcomes (1)
precision of verticality perception - baseline and change over 3 months
The precision of verticality perception is defined as the individual median absolute deviation of single line adjustments along perceived direction of vertical (units: degrees). Repetitive adjustments will be collected while on the turntable, each adjustment lasting up to 15seconds. The resulting value reflects the amount of trial-to-trial variability in a given subject, which is inverse correlated to the precision.
Measured: at baseline for the control group (while on the turntable for 1 hour) and change from baseline to follow-up after 3 months for the acute vestibular loss group (again over 1 hour while on the turntable)
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 startJul 2013
- Primary completion1 May 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular PerceptionStudies 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
- 72 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, Division of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212847
- Sponsor's protocol ID
- vest_loss_percept_zurich
- Status last verified
- Jun 2018
- First submitted
- 2 Jul 2014
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- 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
- Spatial Orientation and Vestibular Function in Patients With Acute or Chronic Unilateral Vestibular Deficits and in Patients With Bilateral Vestibular Deficits
- ClinicalTrials.gov ID
- NCT02212847
- Acronym / sponsor ID
- vest_loss_percept_zurich
- Conditions
- Vestibular Perception, Damaged Vestibular System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 28 Jun 2018 (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.
Spatial orientation is achieved through central integration of various sensory inputs and prior knowledge in a statistically optimal way based on the reliability of the different signals. When upright, the subjective visual vertical (SVV) is accurate and precise in healthy human subjects. However, when roll-tilted, both systematic physiologic, roll-angle dependent errors (termed A- und E-effect) and a decrease in precision of SVV estimates have been described. In case of a sudden unilateral vestibular deficit (UVD) a significant imbalance between the two vestibular organs occurs at the level of the vestibular nuclei, disrupting the percept of vertical. The most frequent cause for such a unilateral vestibular deficit is an inflammation of the vestibular nerve by viral infection, termed vestibular neuritis (VN). While in the acute stage these patients are usually immobilized due to the severity of symptoms, recovery is overall good and most patients return to their daily activities within a few weeks. Central compensation is considered the most important contributor to recovery in these patients, while recovery of the damaged vestibular nerve occurs only in a minority of cases. While acute VN presents with sudden UVD, bilateral vestibular deficits (BVD) typically evolve more slowly and re-sult in distinct complaints.
The percept of vertical can be quantified by assessing the subjective visual vertical or SVV, which is usually done by letting subjects adjust a luminous line along perceived direction of gravity. Modifications of this paradigm which are independent from retinal input are e.g. adjustments of a rod along perceived vertical in complete darkness (termed subjective haptic vertical or SHV) and self-alignments along perceived vertical (subjective postural vertical or SPV) and perceived horizontal (subjective postural horizontal or SPH) in complete darkness. Previous research has proposed no unified percept of vertical as errors assessed in different domains (visual, haptic, postural) were diverging in patients with acute UVD. While errors were profound for the SVV, the SPV remained accurate.
Here the investigators aim to quantify verticality perception in patients with either acute or chronic UVD and patients with BVD both in upright and roll-tilted positions. Specifically, the investigators will use different paradigms to address the ques-tion whether there is a unified percept of vertical and how a bias in this percept changes over time.
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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ages 18-75
- informed consent
- for group 1: acute (i.e. symptom onset less than 72 hours ago) unilateral vestibular deficit as confirmed by clinical examination (pathologic head-impulse test, no skew deviation, no gaze-evoked nystagmus).
- for group 2: chronic (i.e. symptom onset more than 4 weeks ago) unilateral vestibular deficit as confirmed by vestibular testing in the acute stage (either abnormal unilateral response on caloric irrigation or video-head-impulse testing).
- for group 3: chronic (i.e. symptom onset more than 4 weeks ago) bilateral vestibular deficits as confirmed by vestibular testing (bilaterally reduced response on caloric irrigation or video-head impulse testing).
Key exclusion criteria (8 listed)
- History of a peripheral-vestibular deficit (valid only for group 4 - controls)
- Disturbed consciousness
- Personal history of traumatic brain injury, cerebrovascular disorders, seizures
- History of chronic neck complaints including severe neck pain.
- Alcohol dependency
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 | Other | vestibular stimulation |
Primary outcome
accuracy of verticality perception - baseline and change over 3 months
Time frame: at baseline for the control group (while on the turntable over 1 hour) and change from baseline to follow-up after 3 months for the acute vestibular loss group (again over 1 hour)
The accuracy of verticality perception is defined as the individual median value of a series of line adjustments along perceived direction of gravity (units: degrees). this results in a report of the participants perceived direction of gravity relative to true earth-vertical. Repetitive adjustments will be collected while on the turntable, each adjustment lasting up to 15seconds.
1 secondary outcome
precision of verticality perception - baseline and change over 3 months
Time frame: at baseline for the control group (while on the turntable for 1 hour) and change from baseline to follow-up after 3 months for the acute vestibular loss group (again over 1 hour while on the turntable)
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 2 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Vestibular Perception
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Human Visual and Vestibular Motion Perception Study
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Not yet recruiting
Comparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants
Sensorineural Hearing Loss, Bilateral Hearing Loss
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, Division 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 in people with Vestibular Perception and Damaged Vestibular System, 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 6 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 2 Jul 2018. 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 of verticality perception - baseline and change over 3 months (time frame: at baseline for the control group (while on the turntable over 1 hour) and change from baseline to follow-up after 3 months for the acute vestibular loss group (again over 1 hour)). 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.