<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/NCT02184923</url>
  </required_header>
  <id_info>
    <org_study_id>verticality_percept_stroke_zrh</org_study_id>
    <nct_id>NCT02184923</nct_id>
  </id_info>
  <brief_title>Verticality Perception in Stroke Patients</brief_title>
  <official_title>Verticality Perception in Patients With Acute Lateralized Lesions Along the Central Graviceptive Pathways- Acute Assessment on the Ward and the Stroke Center</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 our knowledge of how information from the&#xD;
      labyrinth is brought to perception and how adaptation to vestibular imbalance influences&#xD;
      spatial orientation. In healthy human subjects verticality perception is accurate while&#xD;
      upright.The strategy of this research is to quantify changes in verticality perception after&#xD;
      unilateral lesions along the central graviceptive pathways and to assess the frequency and&#xD;
      pattern of abnormal verticality perception in patients with acute stroke (ischemic or&#xD;
      hemorrhagic). Our underlying hypothesis is that screening for erroneous verticality&#xD;
      perception by use of a mobile device assessing the subjective visual vertical (SVV) during&#xD;
      the acute phase (i.e., within 24-48 hours after symptom onset) reliably identifies those&#xD;
      patients with defects. Early detection of deficits in verticality perception may help to&#xD;
      initiate balance physiotherapy early.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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</measure>
    <time_frame>during the measurement period (10 minutes)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Test-re-test reliability of verticality perception</measure>
    <time_frame>from session 1 (day 0) to session 2 (day 1)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Verticality Perception in Stroke</condition>
  <arm_group>
    <arm_group_label>verticality measurements</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>presentation of visual vertical</intervention_name>
    <arm_group_label>verticality measurements</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ages 18-90 years&#xD;
&#xD;
          2. informed consent&#xD;
&#xD;
          3. for group 1: acute (i.e. symptom onset &lt;3 days ago) lateralized ischemia or hemorrhage&#xD;
             as confirmed by clinical examination and / or brain imaging (CT or MRI).&#xD;
&#xD;
          4. absence of exclusion criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. history of a peripheral-vestibular deficit&#xD;
&#xD;
          2. disturbed consciousness&#xD;
&#xD;
          3. severe sensory or motor aphasia&#xD;
&#xD;
          4. visual field deficits&#xD;
&#xD;
          5. other neurological or systemic disorder which can cause dementia or cognitive&#xD;
             dysfunction&#xD;
&#xD;
          6. intake of antidepressants, sedatives, or neuroleptics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dominik Straumann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Zurich, Division of Neurology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <state>ZH</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Zwergal A, Rettinger N, Frenzel C, Dieterich M, Brandt T, Strupp M. A bucket of static vestibular function. Neurology. 2009 May 12;72(19):1689-92. doi: 10.1212/WNL.0b013e3181a55ecf.</citation>
    <PMID>19433743</PMID>
  </reference>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- 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/NCT02184923
org study id: verticality_percept_stroke_zrh
nct id: NCT02184923
lead sponsor: 
has dmc: No
The long-term goal of this research is to advance our knowledge of how information from the
      labyrinth is brought to perception and how adaptation to vestibular imbalance influences
      spatial orientation. In healthy human subjects verticality perception is accurate while
      upright.The strategy of this research is to quantify changes in verticality perception after
      unilateral lesions along the central graviceptive pathways and to assess the frequency and
      pattern of abnormal verticality perception in patients with acute stroke (ischemic or
      hemorrhagic). Our underlying hypothesis is that screening for erroneous verticality
      perception by use of a mobile device assessing the subjective visual vertical (SVV) during
      the acute phase (i.e., within 24-48 hours after symptom onset) reliably identifies those
      patients with defects. Early detection of deficits in verticality perception may help to
      initiate balance physiotherapy early.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Accuracy of verticality perception
time frame: during the measurement period (10 minutes)
measure: Test-re-test reliability of verticality perception
time frame: from session 1 (day 0) to session 2 (day 1)
arm group label: verticality measurements
arm group type: Experimental
intervention type: Other
intervention name: presentation of visual vertical
arm group label: verticality measurements
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dominik Straumann, MD
role: Principal Investigator
affiliation: University Hospital Zurich, Division of Neurology
facility: 
country: Switzerland
citation: Zwergal A, Rettinger N, Frenzel C, Dieterich M, Brandt T, Strupp M. A bucket of static vestibular function. Neurology. 2009 May 12;72(19):1689-92. doi: 10.1212/WNL.0b013e3181a55ecf.
PMID: 19433743
responsible party type: Sponsor
mesh term: Stroke