<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/NCT02185313</url>
  </required_header>
  <id_info>
    <org_study_id>gaze_holding_cerebellar_zurich</org_study_id>
    <nct_id>NCT02185313</nct_id>
  </id_info>
  <brief_title>Gaze Holding in Cerebellar Patients</brief_title>
  <official_title>Verticality Perception and Gaze Holding in Healthy Human Subjects and Patients With Acute and Chronic Cerebellar Disorders</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;
      cerebellum a) controls gaze holding and compensates for impaired gaze stability and b)&#xD;
      modulates vestibular information that is forward-ed from the labyrinth and brought to&#xD;
      perception. While gaze holding is stable also at large angles of gaze eccentricity in healthy&#xD;
      human subjects, patients with chronic (degenerative) cerebellar disorders are inable to&#xD;
      stabilize gaze in eccentric positions, resulting in eye drift towards primary&#xD;
      (straight-ahead) position and com-pensatory gaze-evoked nystagmus. When returning to primary&#xD;
      position, a compensatory nystagmus into the opposite direction (called rebound nystagmus) can&#xD;
      be observed in these patients. Unlike patients with de-generative cerebellar disorders,&#xD;
      patients suffering from ischemic of hemorrhagic stroke within the cerebellum present with&#xD;
      acute deficits of gaze holding and verticality perception.&#xD;
&#xD;
      While a linear relationship between the amount of eye velocity drift and eccentricity of eye&#xD;
      position has been proposed in healthy human subjects, others suggested non-linear behaviour.&#xD;
      The strategy of this research is to characterize gaze holding and verticality perception in&#xD;
      healthy human subjects and patients with either acute (ischemic or hemorrhagic) or chronic&#xD;
      degenerative cerebellar disorders and to relate eye movement findings with structural imaging&#xD;
      of the cerebellum. The investigators will therefore analyze key cerebellar structures with&#xD;
      regards to loss of volume and relate these imaging findings with the participants' ability to&#xD;
      hold gaze and es-timate direction of vertical. The investigators hypothesize that besides the&#xD;
      flocculus other vestibulo-cerebellar structures are involved in gaze holding and verticality&#xD;
      perception in humans.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2013</start_date>
  <completion_date type="Actual">November 30, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 2019</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>eye velocity in relation to eye position</measure>
    <time_frame>during the visual stimulus (5min)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>symmetry of eye velocity for right vs. left gaze</measure>
    <time_frame>during the visual stimulus (5min)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Gaze Holding in Humans</condition>
  <condition>Rebound in Humans</condition>
  <arm_group>
    <arm_group_label>gaze holding</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>visual stimulus to follow</intervention_name>
    <arm_group_label>gaze holding</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ages 18-85&#xD;
&#xD;
          2. informed consent&#xD;
&#xD;
          3. for group 1: acute (i.e. symptom onset &lt;14 days ago) cerebellar ischemia or hemorrhage&#xD;
             as confirmed by clinical examination and brain imaging (CT or MRI)&#xD;
&#xD;
          4. for group 2: chronic cerebellar degeneration as confirmed by clinical examination&#xD;
             (presence of downbeat-nystagmus and / or gaze-evoked nystagmus and / or ataxia of gait&#xD;
             and stance) in the absence of focal lesions (as previous cerebellar stroke, mass&#xD;
             lesion or inflammation) on clinical routine cerebellar imaging&#xD;
&#xD;
          5. absence of exclusion criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. has MRI contraindications such as pacemaker, implanted pumps, shrapnel, etc. (full MRI&#xD;
             screening form will be filled out).&#xD;
&#xD;
          2. disturbed consciousness&#xD;
&#xD;
          3. other neurological or systemic disorder which can cause dementia or cognitive&#xD;
             dysfunction&#xD;
&#xD;
          4. 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>85 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>December 2019</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 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>
  <!-- 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/NCT02185313
org study id: gaze_holding_cerebellar_zurich
nct id: NCT02185313
lead sponsor: 
has dmc: No
The long-term goal of this research is to advance the investigators knowledge of how the
      cerebellum a) controls gaze holding and compensates for impaired gaze stability and b)
      modulates vestibular information that is forward-ed from the labyrinth and brought to
      perception. While gaze holding is stable also at large angles of gaze eccentricity in healthy
      human subjects, patients with chronic (degenerative) cerebellar disorders are inable to
      stabilize gaze in eccentric positions, resulting in eye drift towards primary
      (straight-ahead) position and com-pensatory gaze-evoked nystagmus. When returning to primary
      position, a compensatory nystagmus into the opposite direction (called rebound nystagmus) can
      be observed in these patients. Unlike patients with de-generative cerebellar disorders,
      patients suffering from ischemic of hemorrhagic stroke within the cerebellum present with
      acute deficits of gaze holding and verticality perception.

      While a linear relationship between the amount of eye velocity drift and eccentricity of eye
      position has been proposed in healthy human subjects, others suggested non-linear behaviour.
      The strategy of this research is to characterize gaze holding and verticality perception in
      healthy human subjects and patients with either acute (ischemic or hemorrhagic) or chronic
      degenerative cerebellar disorders and to relate eye movement findings with structural imaging
      of the cerebellum. The investigators will therefore analyze key cerebellar structures with
      regards to loss of volume and relate these imaging findings with the participants' ability to
      hold gaze and es-timate direction of vertical. The investigators hypothesize that besides the
      flocculus other vestibulo-cerebellar structures are involved in gaze holding and verticality
      perception in humans.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: eye velocity in relation to eye position
time frame: during the visual stimulus (5min)
measure: symmetry of eye velocity for right vs. left gaze
time frame: during the visual stimulus (5min)
arm group label: gaze holding
arm group type: Experimental
intervention type: Other
intervention name: visual stimulus to follow
arm group label: gaze holding
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 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