<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/NCT02212704</url>
  </required_header>
  <id_info>
    <org_study_id>perception_head_roll_zurich</org_study_id>
    <nct_id>NCT02212704</nct_id>
  </id_info>
  <brief_title>Verticality Perception - Multisensory Contribution</brief_title>
  <official_title>Verticality Perception - Dissociating Head and Trunk Contributors in Healthy Human Subjects</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>
      The purpose of this study is to evaluate the relative contribution of head- and trunk-based&#xD;
      sensory systems to internal estimates of direction of gravity in healthy human subjects. To&#xD;
      implement this assessment experimentally, the investigators will use a motor-driven&#xD;
      3D-turntable and a thermoplastic mask to keep the head in a stable, either roll-tilted (±30°)&#xD;
      or aligned with the trunk. The investigators will then obtain measurements of the subjective&#xD;
      visual vertical in seven different whole-body roll positions (max. 90° roll-tilt). Analysis&#xD;
      will be driven by a state-of-the art Bayesian integration model. The investigators&#xD;
      hypothesize that different sensory input signals are combined in a statistically optimal&#xD;
      fashion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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 and precision of SVV adjustments in different head and trunk roll-tilt positions</measure>
    <time_frame>During the turntable measurement (90 minutes)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>relative contribution of head- and trunk-based sensory systems based on Bayesian modelling</measure>
    <time_frame>while on the turntable (1.5 hours)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Verticality Perception in Healthy Human Subjects</condition>
  <condition>Individual Contribution of Different Sensory Systems</condition>
  <arm_group>
    <arm_group_label>Vestibular stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is the experimental paradigm applied in all participants</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vestibular stimulation by use of the turntable (static roll-tilt while the head is roll-tilted relative to the trunk)</intervention_name>
    <arm_group_label>Vestibular stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>3D-video-head impulse testing</intervention_name>
    <description>Evaluation of semicircular canal function. This intervention is part of the screening to determine suitability for this study</description>
    <arm_group_label>Vestibular stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vestibular-evoked myogenic potentials (VEMPs)</intervention_name>
    <description>Evaluation of otolith function. This intervention is part of the screening to determine suitability for this study</description>
    <arm_group_label>Vestibular stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ages 18-60 years&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  absence of exclusion criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  peripheral-vestibular deficit&#xD;
&#xD;
          -  disturbed consciousness&#xD;
&#xD;
          -  history of sensory deficits&#xD;
&#xD;
          -  visual field deficits&#xD;
&#xD;
          -  other neurological or systemic disorder which can cause dementia or cognitive&#xD;
             dysfunction&#xD;
&#xD;
          -  intake of antidepressants, sedatives, or neuroleptics&#xD;
&#xD;
          -  pregnancy, unless excluded by a negative pregnancy test&#xD;
&#xD;
          -  known neck pain or status post neck trauma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 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, Dept. of Neurology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich, Dept. 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>December 2015</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>December 1, 2015</last_update_submitted>
  <last_update_submitted_qc>December 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vestibular</keyword>
  <keyword>proprioception</keyword>
  <keyword>spatial orientation</keyword>
  <keyword>bayesian</keyword>
  <!-- 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/NCT02212704
org study id: perception_head_roll_zurich
nct id: NCT02212704
lead sponsor: 
has dmc: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Accuracy and precision of SVV adjustments in different head and trunk roll-tilt positions
time frame: During the turntable measurement (90 minutes)
measure: relative contribution of head- and trunk-based sensory systems based on Bayesian modelling
time frame: while on the turntable (1.5 hours)
arm group label: Vestibular stimulation
arm group type: Experimental
description: This is the experimental paradigm applied in all participants
intervention type: Other
intervention name: Vestibular stimulation by use of the turntable (static roll-tilt while the head is roll-tilted relative to the trunk)
arm group label: Vestibular stimulation
intervention type: Other
intervention name: 3D-video-head impulse testing
description: Evaluation of semicircular canal function. This intervention is part of the screening to determine suitability for this study
arm group label: Vestibular stimulation
intervention type: Other
intervention name: Vestibular-evoked myogenic potentials (VEMPs)
description: Evaluation of otolith function. This intervention is part of the screening to determine suitability for this study
arm group label: Vestibular stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dominik Straumann, Prof, MD
role: Principal Investigator
affiliation: University Hospital Zurich, Dept. of Neurology
facility: 
country: Switzerland
responsible party type: Sponsor