xml: <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/NCT06017908</url>
    </required_header>
    <id_info>
      <org_study_id>23079_OKAN</org_study_id>
      <nct_id>NCT06017908</nct_id>
    </id_info>
    <brief_title>Identification of Visual Dependence in PPPD Patients With the Aid of Virtual Reality.</brief_title>
    <acronym>OKAN</acronym>
    <official_title>Identification of Visual Dependence in PPPD Patients With an Enhanced Rod and Disc Test (RDT) and Optokinetic After Nystagmus (OKAN) With the Aid of Virtual Reality.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitair Ziekenhuis Brussel</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitair Ziekenhuis Brussel</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to evaluate whether increased visual dependence can be identified&#xD;
        with the help of Virtual Reality (VR). Increased visual dependence is a general term for&#xD;
        patients with increased dependence on vision in maintaining their balance. Patients suffering&#xD;
        from persistent postural perceptual vertigo (PPPD) often suffer from increased visual&#xD;
        dependence. This in turn leads to complaints such as visual vertigo, agoraphobia and fear of&#xD;
        falling. Visual dependence is normally measured using the optokinetic after nystagmus (OKAN)&#xD;
        and the rod and disc test (RDT). In this study, these two tests are performed with the aid of&#xD;
        Virtual Reality.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of this study is to evaluate whether increased visual dependence can be identified&#xD;
        with the help of Virtual Reality (VR). Visual dependence is normally measured using the&#xD;
        optokinetic after nystagmus (OKAN) and the rod and disc test (RDT). In this study, these two&#xD;
        tests are performed with the aid of Virtual Reality. The OKAN is measured by eye tracking, a&#xD;
        key item already used daily in instruments such as video nystagmography (VNG) and video head&#xD;
        impulse test (vHIT). Another test representative of visual dependence is the Rod and Disc&#xD;
        test (RDT). In the RDT, patients are asked to complete a visual task so that researchers gain&#xD;
        more knowledge about visual dependence. Until now, these tests have been performed using a&#xD;
        large set-up and many different materials. Moreover, the exact underlying mechanism of visual&#xD;
        dependence in PPPD patients is still unknown. The aim of this study is to investigate whether&#xD;
        Virtual Reality can be a useful tool when performing the OKAN and RDT. In this way, a better&#xD;
        understanding of visual dependence is sought. This study aims to determine the normative&#xD;
        values for the OKAN and RDT performed with the aid of Virtual Reality. Therefore, a healthy&#xD;
        group of individuals will be compared with PPPD patients as they suffer from visual&#xD;
        dependence. To evaluate the effectiveness of the OKAN and RDT via VR, the results will be&#xD;
        compared with the scores of the visual vertigo analogue scale (VVAS), a questionnaire to&#xD;
        assess visual dependence.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">July 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Intervention of the Virtual Reality goggles will be evaluated in a small clinical trial to determine the feasibility of the product.</intervention_model_description>
      <primary_purpose>Device Feasibility</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Device feasibility</measure>
      <time_frame>1 year</time_frame>
      <description>Time constant and velocity of eye movements</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>PPPD</condition>
    <arm_group>
      <arm_group_label>PPPD patients</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Virtual Reality will be used to execute the RDT and OKAN in PPPD patients.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy patients</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Virtual Reality will be used to execute the RDT and OKAN in healthy PPPD patients.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Optokinetic stimulation through Virtual Reality</intervention_name>
      <description>The experiment will be conducted in two phases. In the first experiment the patients will be passively watch the visual images while seated. An optokinetic stimulus will be delivered through the VR headset by displaying rotating visual patterns. In the second trial they will have to perform the enhanced rod and disc test.</description>
      <arm_group_label>Healthy patients</arm_group_label>
      <arm_group_label>PPPD patients</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients with chronic vertigo (&gt;3 months)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Minors&#xD;
  &#xD;
            -  Patients with a history of epilepsy.&#xD;
  &#xD;
            -  Patients with an alcohol use disorder&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Vedat Topsakal, Prof, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Free University of Brussels</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marie Reynders, MD</last_name>
      <phone>+32477261213</phone>
      <email>marie.reynders@uzbrussel.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Vedat Topsakal, Prof, MD</last_name>
      <email>vedat.topsakal@uzbrussel.be</email>
    </overall_contact_backup>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>March 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Virtual Reality</keyword>
    <keyword>PPPD</keyword>
    <keyword>Rod and Disc Test</keyword>
    <keyword>Optokinetic after nystagmus</keyword>
    <keyword>Visual dependence</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06017908
  org study id: 23079_OKAN
  nct id: NCT06017908
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate whether increased visual dependence can be identified
        with the help of Virtual Reality (VR). Increased visual dependence is a general term for
        patients with increased dependence on vision in maintaining their balance. Patients suffering
        from persistent postural perceptual vertigo (PPPD) often suffer from increased visual
        dependence. This in turn leads to complaints such as visual vertigo, agoraphobia and fear of
        falling. Visual dependence is normally measured using the optokinetic after nystagmus (OKAN)
        and the rod and disc test (RDT). In this study, these two tests are performed with the aid of
        Virtual Reality.
  The aim of this study is to evaluate whether increased visual dependence can be identified
        with the help of Virtual Reality (VR). Visual dependence is normally measured using the
        optokinetic after nystagmus (OKAN) and the rod and disc test (RDT). In this study, these two
        tests are performed with the aid of Virtual Reality. The OKAN is measured by eye tracking, a
        key item already used daily in instruments such as video nystagmography (VNG) and video head
        impulse test (vHIT). Another test representative of visual dependence is the Rod and Disc
        test (RDT). In the RDT, patients are asked to complete a visual task so that researchers gain
        more knowledge about visual dependence. Until now, these tests have been performed using a
        large set-up and many different materials. Moreover, the exact underlying mechanism of visual
        dependence in PPPD patients is still unknown. The aim of this study is to investigate whether
        Virtual Reality can be a useful tool when performing the OKAN and RDT. In this way, a better
        understanding of visual dependence is sought. This study aims to determine the normative
        values for the OKAN and RDT performed with the aid of Virtual Reality. Therefore, a healthy
        group of individuals will be compared with PPPD patients as they suffer from visual
        dependence. To evaluate the effectiveness of the OKAN and RDT via VR, the results will be
        compared with the scores of the visual vertigo analogue scale (VVAS), a questionnaire to
        assess visual dependence.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  intervention model description: Intervention of the Virtual Reality goggles will be evaluated in a small clinical trial to determine the feasibility of the product.
  primary purpose: Device Feasibility
  masking: None (Open Label)
  measure: Device feasibility
  time frame: 1 year
  description: Time constant and velocity of eye movements
  arm group label: PPPD patients
  arm group type: Experimental
  description: Virtual Reality will be used to execute the RDT and OKAN in PPPD patients.
  arm group label: Healthy patients
  arm group type: Experimental
  description: Virtual Reality will be used to execute the RDT and OKAN in healthy PPPD patients.
  intervention type: Device
  intervention name: Optokinetic stimulation through Virtual Reality
  description: The experiment will be conducted in two phases. In the first experiment the patients will be passively watch the visual images while seated. An optokinetic stimulus will be delivered through the VR headset by displaying rotating visual patterns. In the second trial they will have to perform the enhanced rod and disc test.
  arm group label: Healthy patients
  arm group label: PPPD patients
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Vedat Topsakal, Prof, MD
  role: Principal Investigator
  affiliation: Free University of Brussels
  last name: Marie Reynders, MD
  phone: +32477261213
  email: marie.reynders@uzbrussel.be
  last name: Vedat Topsakal, Prof, MD
  email: vedat.topsakal@uzbrussel.be
  responsible party type: Sponsor
  sharing ipd: No