Damaged Vestibular System Clinical Trial
Official title:
Spatial Orientation and Vestibular Function in Patients With Acute or Chronic Unilateral Vestibular Deficits and in Patients With Bilateral Vestibular Deficits
| Verified date | June 2018 |
| Source | University of Zurich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 72 |
| Est. completion date | June 28, 2018 |
| Est. primary completion date | May 1, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: 1. ages 18-75 2. informed consent 3. 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). 4. 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). 5. 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). 6. absence of exclusion criteria Exclusion Criteria: 1. History of a peripheral-vestibular deficit (valid only for group 4 - controls) 2. Disturbed consciousness 3. Personal history of traumatic brain injury, cerebrovascular disorders, seizures 4. History of chronic neck complaints including severe neck pain. 5. Alcohol dependency 6. Intake of anxiolytic, antidepressant, neuroleptic or sedative medication 7. Other neurological or systemic disorder which can cause cerebellar deficits, dementia, cognitive dysfunction, visuospatial or tactile neglect, aphasia or visual field deficits 8. Pregnancy or possible pregnancy if not ruled out by a negative pregnancy test. |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University Hospital Zurich, Division of Neurology | Zurich | ZH |
| Lead Sponsor | Collaborator |
|---|---|
| University of Zurich |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 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 | 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. | 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) |