<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02212847</url>
  </required_header>
  <id_info>
    <org_study_id>vest_loss_percept_zurich</org_study_id>
    <nct_id>NCT02212847</nct_id>
  </id_info>
  <brief_title>Spatial Orientation and Vestibular Function</brief_title>
  <official_title>Spatial Orientation and Vestibular Function in Patients With Acute or Chronic Unilateral Vestibular Deficits and in Patients With Bilateral Vestibular Deficits</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Spatial orientation is achieved through central integration of various sensory inputs and&#xD;
      prior knowledge in a statistically optimal way based on the reliability of the different&#xD;
      signals. When upright, the subjective visual vertical (SVV) is accurate and precise in&#xD;
      healthy human subjects. However, when roll-tilted, both systematic physiologic, roll-angle&#xD;
      dependent errors (termed A- und E-effect) and a decrease in precision of SVV estimates have&#xD;
      been described. In case of a sudden unilateral vestibular deficit (UVD) a significant&#xD;
      imbalance between the two vestibular organs occurs at the level of the vestibular nuclei,&#xD;
      disrupting the percept of vertical. The most frequent cause for such a unilateral vestibular&#xD;
      deficit is an inflammation of the vestibular nerve by viral infection, termed vestibular&#xD;
      neuritis (VN). While in the acute stage these patients are usually immobilized due to the&#xD;
      severity of symptoms, recovery is overall good and most patients return to their daily&#xD;
      activities within a few weeks. Central compensation is considered the most important&#xD;
      contributor to recovery in these patients, while recovery of the damaged vestibular nerve&#xD;
      occurs only in a minority of cases. While acute VN presents with sudden UVD, bilateral&#xD;
      vestibular deficits (BVD) typically evolve more slowly and re-sult in distinct complaints.&#xD;
&#xD;
      The percept of vertical can be quantified by assessing the subjective visual vertical or SVV,&#xD;
      which is usually done by letting subjects adjust a luminous line along perceived direction of&#xD;
      gravity. Modifications of this paradigm which are independent from retinal input are e.g.&#xD;
      adjustments of a rod along perceived vertical in complete darkness (termed subjective haptic&#xD;
      vertical or SHV) and self-alignments along perceived vertical (subjective postural vertical&#xD;
      or SPV) and perceived horizontal (subjective postural horizontal or SPH) in complete&#xD;
      darkness. Previous research has proposed no unified percept of vertical as errors assessed in&#xD;
      different domains (visual, haptic, postural) were diverging in patients with acute UVD. While&#xD;
      errors were profound for the SVV, the SPV remained accurate.&#xD;
&#xD;
      Here the investigators aim to quantify verticality perception in patients with either acute&#xD;
      or chronic UVD and patients with BVD both in upright and roll-tilted positions. Specifically,&#xD;
      the investigators will use different paradigms to address the ques-tion whether there is a&#xD;
      unified percept of vertical and how a bias in this percept changes over time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">June 28, 2018</completion_date>
  <primary_completion_date type="Actual">May 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>accuracy of verticality perception - baseline and change over 3 months</measure>
    <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)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>precision of verticality perception - baseline and change over 3 months</measure>
    <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)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Vestibular Perception</condition>
  <condition>Damaged Vestibular System</condition>
  <arm_group>
    <arm_group_label>vestibular stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>vestibular stimulation</intervention_name>
    <arm_group_label>vestibular stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ages 18-75&#xD;
&#xD;
          2. informed consent&#xD;
&#xD;
          3. for group 1: acute (i.e. symptom onset less than 72 hours ago) unilateral vestibular&#xD;
             deficit as confirmed by clinical examination (pathologic head-impulse test, no skew&#xD;
             deviation, no gaze-evoked nystagmus).&#xD;
&#xD;
          4. for group 2: chronic (i.e. symptom onset more than 4 weeks ago) unilateral vestibular&#xD;
             deficit as confirmed by vestibular testing in the acute stage (either abnormal&#xD;
             unilateral response on caloric irrigation or video-head-impulse testing).&#xD;
&#xD;
          5. for group 3: chronic (i.e. symptom onset more than 4 weeks ago) bilateral vestibular&#xD;
             deficits as confirmed by vestibular testing (bilaterally reduced response on caloric&#xD;
             irrigation or video-head impulse testing).&#xD;
&#xD;
          6. absence of exclusion criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of a peripheral-vestibular deficit (valid only for group 4 - controls)&#xD;
&#xD;
          2. Disturbed consciousness&#xD;
&#xD;
          3. Personal history of traumatic brain injury, cerebrovascular disorders, seizures&#xD;
&#xD;
          4. History of chronic neck complaints including severe neck pain.&#xD;
&#xD;
          5. Alcohol dependency&#xD;
&#xD;
          6. Intake of anxiolytic, antidepressant, neuroleptic or sedative medication&#xD;
&#xD;
          7. Other neurological or systemic disorder which can cause cerebellar deficits, dementia,&#xD;
             cognitive dysfunction, visuospatial or tactile neglect, aphasia or visual field&#xD;
             deficits&#xD;
&#xD;
          8. Pregnancy or possible pregnancy if not ruled out by a negative pregnancy test.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dominik Straumann, Prof MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Zurich, Division of Neurology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich, Division of Neurology</name>
      <address>
        <city>Zurich</city>
        <state>ZH</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>June 28, 2018</last_update_submitted>
  <last_update_submitted_qc>June 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02212847
org study id: vest_loss_percept_zurich
nct id: NCT02212847
lead sponsor: 
has dmc: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
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)
description: 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.
measure: 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)
description: 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.
arm group label: vestibular stimulation
arm group type: Experimental
intervention type: Other
intervention name: vestibular stimulation
arm group label: vestibular stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dominik Straumann, Prof MD
role: Principal Investigator
affiliation: University Hospital Zurich, Division of Neurology
facility: 
country: Switzerland
responsible party type: Sponsor
sharing ipd: No