<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/NCT02980419</url>
  </required_header>
  <id_info>
    <org_study_id>post_tilt_study</org_study_id>
    <nct_id>NCT02980419</nct_id>
  </id_info>
  <brief_title>Effects of Prolonged Roll-tilt in Healthy Human Subjects</brief_title>
  <official_title>Erticality Perception - Effects of Prolonged Roll-tilt 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 long-term goal of this research is to advance the investigators knowledge of how the&#xD;
      brain combines the information of multiple sensory systems coding for spatial oriention and&#xD;
      how adaptation to vestibular imbalance influences spatial orientation. In healthy human&#xD;
      subjects verticality perception is accurate while upright. After prolonged roll-tilt, humans&#xD;
      show a systematic bias in perceived direction towards the previous roll-tilted position&#xD;
      (so-called &quot;post-tilt bias&quot;). This effect could either be related to adaptation to the&#xD;
      roll-tilted position (shifting the &quot;null&quot; position) or it could be related to changes in&#xD;
      torsional eye position due to prolonged static roll-tilt (ocular counter-roll). While in the&#xD;
      first case a post-tilt bias is predicted independently of the experimental paradigm used, the&#xD;
      second hypothesis predicts a post-tilt bias only if retinal cues are integrated. In order to&#xD;
      evaluate these hypotheses, the investigators will assess perceived vertical using both&#xD;
      vision-dependent and vision-independent paradigms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Anticipated">May 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2020</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>adjustment errors of the subjective visual/haptic/postural vertical in upright position after prolonged whole-body roll-tilt positions.</measure>
    <time_frame>10 minutes (i.e. short-term adaptation)</time_frame>
    <description>the accuracy and precision of visual vertical adjustments after prolonged roll tilt are quantified.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in adjustment errors of the subjective visual vertical when providing an additional optokinetic stimulus</measure>
    <time_frame>10 minutes (i.e. short-term adaptation)</time_frame>
    <description>This is the same as in outcome 1, but an additional visual (optokinetic) stimulus is added</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in adjustment errors of the subjective haptic vertical when providing an additional optokinetic stimulus</measure>
    <time_frame>10 minutes (i.e. short-term adaptation)</time_frame>
    <description>This is the same as in outcome 1, but an additional visual (optokinetic) stimulus is added</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in adjustment errors of the subjective postural vertical when providing an additional optokinetic stimulus</measure>
    <time_frame>10 minutes (i.e. short-term adaptation)</time_frame>
    <description>This is the same as in outcome 1, but an additional visual (optokinetic) stimulus is added</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Adaptation Reaction</condition>
  <arm_group>
    <arm_group_label>intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In each participant the investigators will assess verticality perception in whole-body upright position by use of the SVV, the SPV and the SHV after static roll-tilt at ±90deg over 5min. Measurements will be obtained on a motor-driven turntable and two different roll-tilt positions will be applied (±90°). A visual line (SVV), a rod (SHV) or the turntable itself will be adjusted to indicate perceived direction of vertical. A total of three measuring sessions, each lasting about 60 minutes are scheduled.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>presentation of visual and vestibular stimuli</intervention_name>
    <description>In each participant the investigators will assess verticality perception in whole-body upright position by use of the SVV, the SPV and the SHV after static roll-tilt at ±90deg over 5min. Measurements will be obtained on a motor-driven turntable and two different roll-tilt positions will be applied (±90°). A visual line (SVV), a rod (SHV) or the turntable itself will be adjusted to indicate perceived direction of vertical. A total of three measuring sessions, each lasting about 60 minutes are scheduled.</description>
    <arm_group_label>intervention arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ages 18-65 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>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Dominik Straumann, MD</last_name>
    <phone>+41442551111</phone>
    <email>dominik.straumann@usz.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alexander A Tarnutzer, MD</last_name>
    <phone>+41442551111</phone>
    <email>alexander.tarnutzer@usz.ch</email>
  </overall_contact_backup>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexander Tarnutzer, MD</last_name>
      <phone>+41442551111</phone>
      <email>alexander.tarnutzer@usz.ch</email>
    </contact>
    <investigator>
      <last_name>Alexander A Tarnutzer, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrea Wedtgrube</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>January 6, 2020</last_update_submitted>
  <last_update_submitted_qc>January 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2020</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/NCT02980419
org study id: post_tilt_study
nct id: NCT02980419
lead sponsor: 
has dmc: No
The long-term goal of this research is to advance the investigators knowledge of how the
      brain combines the information of multiple sensory systems coding for spatial oriention 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"). This effect could either be related to adaptation to the
      roll-tilted position (shifting the "null" position) or it could be related to changes in
      torsional eye position due to prolonged static roll-tilt (ocular counter-roll). While in the
      first case a post-tilt bias is predicted independently of the experimental paradigm used, the
      second hypothesis predicts a post-tilt bias only if retinal cues are integrated. In order to
      evaluate these hypotheses, the investigators will assess perceived vertical using both
      vision-dependent and vision-independent paradigms.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: adjustment errors of the subjective visual/haptic/postural vertical in upright position after prolonged whole-body roll-tilt positions.
time frame: 10 minutes (i.e. short-term adaptation)
description: the accuracy and precision of visual vertical adjustments after prolonged roll tilt are quantified.
measure: changes in adjustment errors of the subjective visual vertical when providing an additional optokinetic stimulus
time frame: 10 minutes (i.e. short-term adaptation)
description: This is the same as in outcome 1, but an additional visual (optokinetic) stimulus is added
measure: changes in adjustment errors of the subjective haptic vertical when providing an additional optokinetic stimulus
time frame: 10 minutes (i.e. short-term adaptation)
description: This is the same as in outcome 1, but an additional visual (optokinetic) stimulus is added
measure: changes in adjustment errors of the subjective postural vertical when providing an additional optokinetic stimulus
time frame: 10 minutes (i.e. short-term adaptation)
description: This is the same as in outcome 1, but an additional visual (optokinetic) stimulus is added
arm group label: intervention arm
arm group type: Experimental
description: In each participant the investigators will assess verticality perception in whole-body upright position by use of the SVV, the SPV and the SHV after static roll-tilt at ±90deg over 5min. Measurements will be obtained on a motor-driven turntable and two different roll-tilt positions will be applied (±90°). A visual line (SVV), a rod (SHV) or the turntable itself will be adjusted to indicate perceived direction of vertical. A total of three measuring sessions, each lasting about 60 minutes are scheduled.
intervention type: Behavioral
intervention name: presentation of visual and vestibular stimuli
description: In each participant the investigators will assess verticality perception in whole-body upright position by use of the SVV, the SPV and the SHV after static roll-tilt at ±90deg over 5min. Measurements will be obtained on a motor-driven turntable and two different roll-tilt positions will be applied (±90°). A visual line (SVV), a rod (SHV) or the turntable itself will be adjusted to indicate perceived direction of vertical. A total of three measuring sessions, each lasting about 60 minutes are scheduled.
arm group label: intervention arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dominik Straumann, MD
phone: +41442551111
email: dominik.straumann@usz.ch
last name: Alexander A Tarnutzer, MD
phone: +41442551111
email: alexander.tarnutzer@usz.ch
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Switzerland
responsible party type: Sponsor
sharing ipd: No