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/NCT06038175</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00129771</org_study_id>
      <nct_id>NCT06038175</nct_id>
    </id_info>
    <brief_title>vHIT Testing for Presentation of Dizziness at a Comprehensive Stroke Center</brief_title>
    <official_title>Is Video Head Impulse Testing a Safe, Reliable and Cost Effective Method of Assessment of Patients Presenting for Dizziness at a Comprehensive Stroke Center?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of South Carolina</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medical University of South Carolina</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the sensitivity and specificity of the video head&#xD;
        impulse test (vHIT) device, when implemented in the acute ED setting to identify acute&#xD;
        ischemic stroke or central pathology vs peripheral vestibular dysfunction in patient's&#xD;
        presenting with vertigo. This study will evaluate the implementation of the device,&#xD;
        consistency with current diagnostic standards, unnecessary administration of&#xD;
        antithrombolytics and will further study the reduction in hospital admissions and overall&#xD;
        healthcare costs.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In the proposed study, subjects admitted to the Emergency Department (ED) with symptoms of&#xD;
        dizziness, concerning for an acute ischemic stroke, will undergo routine triage (bedside&#xD;
        neurologic examination, head impulse testing, CT scan) and will then be tested with a vHIT&#xD;
        device to attempt to further identify the cause of dizziness, after standard of care testing&#xD;
        has been performed. The clinician performing the vHIT will be blinded to the result of the CT&#xD;
        scan before entering their report.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Single (Investigator)</masking>
      <masking_description>The clinician performing the vHIT will be blinded to the result of the CT scan before entering their report.&#xD;
  The neurotologist reviewing the results of vHIT testing will be blinded to the patient's presentation, neurologic testing, and CT scan results.&#xD;
  the clinician performing the vHIT and the neurotologist reviewing the results of vHIT testing are both members of the Study Team.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Sensitivity &amp; Specificity of vHIT device</measure>
      <time_frame>This will be performed once all results are compiled, not to exceed 90 days after study completion.</time_frame>
      <description>Sensitivity and specificity of the vhit to detect peripheral vestibular dysfunction in an acute presentation of vertigo</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time to perform testing</measure>
      <time_frame>From time the study team member arrives to patient's location until vHIT testing is complete, not to exceed 1 hour.</time_frame>
      <description>The time it takes to perform vHIT testing on a participant admitted for dizziness in the hospital environment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Predictive Value</measure>
      <time_frame>At the time results are compared from vHIT testing to CT scan, not to exceed 30 days post testing.</time_frame>
      <description>We will measure positive predicitive value of vHIT to determine peripheral vestibular involvement in a participant who presents with dizziness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cost Analysis</measure>
      <time_frame>This will be performed once all results are compiled, not to exceed 90 days after study completion.</time_frame>
      <description>We will examine the cost reduction that would have occured if vhit was incorporated in decision making for stroke workup and/or hospital admission</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Stroke, Acute</condition>
    <condition>Vertigo</condition>
    <condition>Vertigo, Peripheral</condition>
    <condition>Dizziness</condition>
    <condition>Dizziness; Syndrome</condition>
    <arm_group>
      <arm_group_label>vHIT testing</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>For the research portion of this study, following standard of care examinations listed above, the patient would have a vHIT headset placed on their head for approximately 3-5 minutes to test if they exhibit corrective saccadic movements and to measure gain reduction to identify vestibular hypofunction. During vHIT testing a commercially available mono-ocular video oculography system will be donned on the patient. Subjects will be instructed to maintain fixation at a target from 1 m distance. A study team member will deliver at least 5 head impulses per side in the horizontal and vertical planes with unpredictable timing and direction. A neurotologist will then evaluate the VOR gain or the ratio of eye velocity over-head velocity. The presence of refixation (catch-up) saccades, either overt or covert, will be evaluated by the study team. In line with previous literature, the vHIT testing will be considered to be abnormal if VOR gain is &lt;0.8 in the presence of refixation saccades .</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard of Care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The intervention group will be compared to standard of care provided to patients currently admitted for dizziness. Standard of care includes National Institute of Health Stroke Scale evaluation, evaluation by a neurologist, and a CT scan or MRI if warranted.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Video Head Impulse Testing</intervention_name>
      <description>During vHIT testing a commercially available mono-ocular video oculography system will be donned on the patient. (Interacoustics EyeSeeCam vHIT 3rd Generation Tests: VOR of lateral, RALP, &amp; LARP canals. SW: 3rd generation VE525 software. HW: laptop PC, lightweight monocular video goggles). Subjects will be instructed to maintain fixation at a target from 1 m distance. A study team member will deliver at least 5 head impulses per side (10-20° angle, duration 150-200 ms, peak velocity of &gt;150°/s) in the horizontal and vertical planes with unpredictable timing and direction. A neurotologist will then evaluate the VOR gain or the ratio of eye velocity over-head velocity. The presence of refixation (catch-up) saccades, either overt or covert, will be evaluated by the study team. In line with previous literature, the vHIT testing will be considered to be abnormal if VOR gain is &lt;0.8 in the presence of refixation saccades .</description>
      <arm_group_label>vHIT testing</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standard of care neurologic evaluation</intervention_name>
      <description>A standard neurologic evaluation will be performed including a National Institute of Health Stroke Scale and imaging if symptoms and NIHSS warrant.</description>
      <arm_group_label>Standard of Care</arm_group_label>
      <arm_group_label>vHIT testing</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults between the ages of 18-90&#xD;
  &#xD;
            -  Admitted to the MUSC ED with symptomatic dizziness, concerning for a stroke vs&#xD;
               peripheral vestibular dysfunction.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prisoners&#xD;
  &#xD;
            -  COVID +&#xD;
  &#xD;
            -  Cognitively Impaired Individuals&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Christine Holmstedt, DO</last_name>
      <phone>8437923020</phone>
      <email>Holmsted@musc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sinead Farrelly, DPT</last_name>
      <email>farrelsi@musc.edu</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
      <investigator_full_name>Christine Holmstedt</investigator_full_name>
      <investigator_title>PI</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vertigo</mesh_term>
      <mesh_term>Stroke</mesh_term>
      <mesh_term>Dizziness</mesh_term>
    </condition_browse>
    <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/NCT06038175
  org study id: Pro00129771
  nct id: NCT06038175
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The purpose of this study is to evaluate the sensitivity and specificity of the video head
        impulse test (vHIT) device, when implemented in the acute ED setting to identify acute
        ischemic stroke or central pathology vs peripheral vestibular dysfunction in patient's
        presenting with vertigo. This study will evaluate the implementation of the device,
        consistency with current diagnostic standards, unnecessary administration of
        antithrombolytics and will further study the reduction in hospital admissions and overall
        healthcare costs.
  In the proposed study, subjects admitted to the Emergency Department (ED) with symptoms of
        dizziness, concerning for an acute ischemic stroke, will undergo routine triage (bedside
        neurologic examination, head impulse testing, CT scan) and will then be tested with a vHIT
        device to attempt to further identify the cause of dizziness, after standard of care testing
        has been performed. The clinician performing the vHIT will be blinded to the result of the CT
        scan before entering their report.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: Single (Investigator)
  masking description: The clinician performing the vHIT will be blinded to the result of the CT scan before entering their report.
  The neurotologist reviewing the results of vHIT testing will be blinded to the patient's presentation, neurologic testing, and CT scan results.
  the clinician performing the vHIT and the neurotologist reviewing the results of vHIT testing are both members of the Study Team.
  measure: Sensitivity & Specificity of vHIT device
  time frame: This will be performed once all results are compiled, not to exceed 90 days after study completion.
  description: Sensitivity and specificity of the vhit to detect peripheral vestibular dysfunction in an acute presentation of vertigo
  measure: Time to perform testing
  time frame: From time the study team member arrives to patient's location until vHIT testing is complete, not to exceed 1 hour.
  description: The time it takes to perform vHIT testing on a participant admitted for dizziness in the hospital environment.
  measure: Predictive Value
  time frame: At the time results are compared from vHIT testing to CT scan, not to exceed 30 days post testing.
  description: We will measure positive predicitive value of vHIT to determine peripheral vestibular involvement in a participant who presents with dizziness.
  measure: Cost Analysis
  time frame: This will be performed once all results are compiled, not to exceed 90 days after study completion.
  description: We will examine the cost reduction that would have occured if vhit was incorporated in decision making for stroke workup and/or hospital admission
  arm group label: vHIT testing
  arm group type: Experimental
  description: For the research portion of this study, following standard of care examinations listed above, the patient would have a vHIT headset placed on their head for approximately 3-5 minutes to test if they exhibit corrective saccadic movements and to measure gain reduction to identify vestibular hypofunction. During vHIT testing a commercially available mono-ocular video oculography system will be donned on the patient. Subjects will be instructed to maintain fixation at a target from 1 m distance. A study team member will deliver at least 5 head impulses per side in the horizontal and vertical planes with unpredictable timing and direction. A neurotologist will then evaluate the VOR gain or the ratio of eye velocity over-head velocity. The presence of refixation (catch-up) saccades, either overt or covert, will be evaluated by the study team. In line with previous literature, the vHIT testing will be considered to be abnormal if VOR gain is <0.8 in the presence of refixation saccades .
  arm group label: Standard of Care
  arm group type: Active Comparator
  description: The intervention group will be compared to standard of care provided to patients currently admitted for dizziness. Standard of care includes National Institute of Health Stroke Scale evaluation, evaluation by a neurologist, and a CT scan or MRI if warranted.
  intervention type: Device
  intervention name: Video Head Impulse Testing
  description: During vHIT testing a commercially available mono-ocular video oculography system will be donned on the patient. (Interacoustics EyeSeeCam vHIT 3rd Generation Tests: VOR of lateral, RALP, & LARP canals. SW: 3rd generation VE525 software. HW: laptop PC, lightweight monocular video goggles). Subjects will be instructed to maintain fixation at a target from 1 m distance. A study team member will deliver at least 5 head impulses per side (10-20° angle, duration 150-200 ms, peak velocity of >150°/s) in the horizontal and vertical planes with unpredictable timing and direction. A neurotologist will then evaluate the VOR gain or the ratio of eye velocity over-head velocity. The presence of refixation (catch-up) saccades, either overt or covert, will be evaluated by the study team. In line with previous literature, the vHIT testing will be considered to be abnormal if VOR gain is <0.8 in the presence of refixation saccades .
  arm group label: vHIT testing
  intervention type: Other
  intervention name: Standard of care neurologic evaluation
  description: A standard neurologic evaluation will be performed including a National Institute of Health Stroke Scale and imaging if symptoms and NIHSS warrant.
  arm group label: Standard of Care
  arm group label: vHIT testing
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Christine Holmstedt, DO
  phone: 8437923020
  email: Holmsted@musc.edu
  last name: Sinead Farrelly, DPT
  email: farrelsi@musc.edu
  responsible party type: Principal Investigator
  investigator affiliation: Medical University of South Carolina
  investigator full name: Christine Holmstedt
  investigator title: PI
  mesh term: Vertigo
  mesh term: Stroke
  mesh term: Dizziness
  sharing ipd: No