<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/NCT02184130</url>
  </required_header>
  <id_info>
    <org_study_id>tms_percept_zurich</org_study_id>
    <nct_id>NCT02184130</nct_id>
  </id_info>
  <brief_title>Altered Vestibular Perception and Transcranial Magnetic Stimulation</brief_title>
  <official_title>Altered Vestibular Perception by Virtual Lesions of Cerebral and Cerebellar Structures Using Repetitive Transcranial Magnetic Stimulation - Implications for Human Vestibular Dysfunction</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;
      motion sensation. Patients with vestibular disorders frequently have disabling disturbances&#xD;
      of perception. Related to these symptoms is that large areas of the cerebral hemispheres and&#xD;
      the cerebellum receive information from the vestibular, visual and somatosensory systems that&#xD;
      is integrated within a vestibular cortical network into an accurate perception of spatial&#xD;
      orientation. Interrupting the pathways that process information about the direction of&#xD;
      gravity and angular velocity leads to impairment of the internal estimate of gravity and the&#xD;
      perception of body motion. The strategy of this research is to use repetitive transcranial&#xD;
      magnetic stimulation (rTMS) to produce transient focal lesions that allow study of acute loss&#xD;
      of function within the central vestibular pathways at the very beginning of adaptation. Our&#xD;
      underlying hypothesis is that the immediate effects of a lesion in the cerebellum will be to&#xD;
      affect ocular motor control of vestibular reflexes and perception alike but with a cortical&#xD;
      lesion there will be dissociation between ocular motor control and perception. This research&#xD;
      helps to understand the mechanisms involved in the perception of vestibular information and&#xD;
      the cerebellar influence on processing vestibular input and offers a unique opportunity to&#xD;
      make major inroads into the understanding and eventually treatment of the often&#xD;
      incapacitating symptoms of patients with vestibular disease&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    insufficient funds and participants, thus terminated&#xD;
  </why_stopped>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">November 2016</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>changes in verticality perception and self-motion perception after TMS (transcranial magnetic stimulation)</measure>
    <time_frame>within 30min after TMS</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>vestibulo-ocular reflex after TMS (transcranial magnetic stimulation)</measure>
    <time_frame>within 30min after TMS</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Verticality Perception</condition>
  <condition>Self-motion Perception</condition>
  <arm_group>
    <arm_group_label>TMS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>transcranial magnetic stimulation and motion stimuli</intervention_name>
    <arm_group_label>TMS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ages 18-70&#xD;
&#xD;
          2. informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. disturbed consciousness&#xD;
&#xD;
          2. other neurological or systemic disorder which can cause dementia or cognitive&#xD;
             dysfunction&#xD;
&#xD;
          3. prior history of a major psychiatric disorder&#xD;
&#xD;
          4. history of definite stroke&#xD;
&#xD;
          5. focal lesion on MRI exam&#xD;
&#xD;
          6. use of anxiolytic, antidepressant, neuroleptic or sedative medication&#xD;
&#xD;
          7. has MRI contraindication such as pacemaker, implanted pumps, shrapnel, etc. (full MRI&#xD;
             screening form will be filled out).&#xD;
&#xD;
          8. History of seizure or a family history of epilepsy;&#xD;
&#xD;
          9. increased intracranial pressure, such as after infarctions or trauma&#xD;
&#xD;
         10. pregnancy or possibility of being pregnant unless precluded by a negative pregnancy&#xD;
             test&#xD;
&#xD;
         11. history of any significant head trauma.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 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>June 2018</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</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>
  <!-- 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/NCT02184130
org study id: tms_percept_zurich
nct id: NCT02184130
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
      motion sensation. Patients with vestibular disorders frequently have disabling disturbances
      of perception. Related to these symptoms is that large areas of the cerebral hemispheres and
      the cerebellum receive information from the vestibular, visual and somatosensory systems that
      is integrated within a vestibular cortical network into an accurate perception of spatial
      orientation. Interrupting the pathways that process information about the direction of
      gravity and angular velocity leads to impairment of the internal estimate of gravity and the
      perception of body motion. The strategy of this research is to use repetitive transcranial
      magnetic stimulation (rTMS) to produce transient focal lesions that allow study of acute loss
      of function within the central vestibular pathways at the very beginning of adaptation. Our
      underlying hypothesis is that the immediate effects of a lesion in the cerebellum will be to
      affect ocular motor control of vestibular reflexes and perception alike but with a cortical
      lesion there will be dissociation between ocular motor control and perception. This research
      helps to understand the mechanisms involved in the perception of vestibular information and
      the cerebellar influence on processing vestibular input and offers a unique opportunity to
      make major inroads into the understanding and eventually treatment of the often
      incapacitating symptoms of patients with vestibular disease
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: changes in verticality perception and self-motion perception after TMS (transcranial magnetic stimulation)
time frame: within 30min after TMS
measure: vestibulo-ocular reflex after TMS (transcranial magnetic stimulation)
time frame: within 30min after TMS
arm group label: TMS
arm group type: Experimental
intervention type: Other
intervention name: transcranial magnetic stimulation and motion stimuli
arm group label: TMS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 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