<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/NCT02980432</url>
  </required_header>
  <id_info>
    <org_study_id>shv_okn_study</org_study_id>
    <nct_id>NCT02980432</nct_id>
  </id_info>
  <brief_title>Verticality Perception Assessed by the Haptic Vertical</brief_title>
  <official_title>Verticality Perception - Modulatory Effect of a Rotating Optokinetic Stimulus on the Haptic Vertical 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 investigators previously shown that a rotating optokinetic stimulus results in shifts of&#xD;
      the subjective visual vertical in healthy human subjects. However, the origin of these shifts&#xD;
      is still poorly understood. Both torsional displacement of the eyes and a shift in the&#xD;
      internal estimate of direction of gravity have been proposed as potential explanations. Here&#xD;
      the investigators use a vision-independent setup to differentiate between these two&#xD;
      hypotheses, predicting no impact of a rotating stimulus on the subjective haptic vertical if&#xD;
      torsion triggers the shift.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">June 28, 2018</completion_date>
  <primary_completion_date type="Actual">June 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>Adjustment errors of aligning a rod along perceived direction of gravity while an optokinetic stimulus is presented.</measure>
    <time_frame>60 minutes</time_frame>
    <description>This outcome parameter focuses on the adjustment errors of the subjective haptic vertical while presenting a visual bias (i.e. an optokinetic rotatory stimulus).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trial-to-trial variability of aligning a rod along perceived direction of gravity while an optokinetic stimulus is presented.</measure>
    <time_frame>60 minutes</time_frame>
    <description>This outcome parameter focuses on the trial-to-trial variability of rod alignments along perceived direction of gravity when presenting a visual bias cue (i.e. an optokinetic rotatory stimulus).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of adjustment errors between the subjective haptic vertical and the subjective visual vertical</measure>
    <time_frame>60 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of adjustment errors of perceived vertical using the subjective haptic vertical with and without presenting an optokinetic stimulus</measure>
    <time_frame>60 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>all participants will be assigned to the same arm. Interventions applied include presenting a visual line or a rod with or without a moving (rotating) background while being in different whole-body roll positions. Participants will be asked to adjust the line or the rod along perceived direction of gravity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>changes in whole-body roll position and visual/haptic stimuli presented</intervention_name>
    <description>In different whole-body roll positions subjects will be presented a luminous line or a rod in combination with a moving or stationary background. Participants will be asked to align the line or the rod along perceived direction of gravity.</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>
  <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>June 2018</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>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>
  <keyword>vestibular</keyword>
  <keyword>spatial orientation</keyword>
  <keyword>vision</keyword>
  <keyword>optokinetic</keyword>
  <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/NCT02980432
org study id: shv_okn_study
nct id: NCT02980432
lead sponsor: 
has dmc: No
The investigators previously shown that a rotating optokinetic stimulus results in shifts of
      the subjective visual vertical in healthy human subjects. However, the origin of these shifts
      is still poorly understood. Both torsional displacement of the eyes and a shift in the
      internal estimate of direction of gravity have been proposed as potential explanations. Here
      the investigators use a vision-independent setup to differentiate between these two
      hypotheses, predicting no impact of a rotating stimulus on the subjective haptic vertical if
      torsion triggers the shift.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Adjustment errors of aligning a rod along perceived direction of gravity while an optokinetic stimulus is presented.
time frame: 60 minutes
description: This outcome parameter focuses on the adjustment errors of the subjective haptic vertical while presenting a visual bias (i.e. an optokinetic rotatory stimulus).
measure: Trial-to-trial variability of aligning a rod along perceived direction of gravity while an optokinetic stimulus is presented.
time frame: 60 minutes
description: This outcome parameter focuses on the trial-to-trial variability of rod alignments along perceived direction of gravity when presenting a visual bias cue (i.e. an optokinetic rotatory stimulus).
measure: Comparison of adjustment errors between the subjective haptic vertical and the subjective visual vertical
time frame: 60 minutes
measure: Comparison of adjustment errors of perceived vertical using the subjective haptic vertical with and without presenting an optokinetic stimulus
time frame: 60 minutes
arm group label: intervention arm
arm group type: Experimental
description: all participants will be assigned to the same arm. Interventions applied include presenting a visual line or a rod with or without a moving (rotating) background while being in different whole-body roll positions. Participants will be asked to adjust the line or the rod along perceived direction of gravity.
intervention type: Other
intervention name: changes in whole-body roll position and visual/haptic stimuli presented
description: In different whole-body roll positions subjects will be presented a luminous line or a rod in combination with a moving or stationary background. Participants will be asked to align the line or the rod along perceived direction of gravity.
arm group label: intervention arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Switzerland
responsible party type: Sponsor
sharing ipd: No