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vHIT Testing for Presentation of Dizziness at a Comprehensive Stroke Center

Primary Purpose

Stroke, Acute, Vertigo, Vertigo, Peripheral

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Video Head Impulse Testing
Standard of care neurologic evaluation
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke, Acute

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults between the ages of 18-90 Admitted to the MUSC ED with symptomatic dizziness, concerning for a stroke vs peripheral vestibular dysfunction. Exclusion Criteria: Prisoners COVID + Cognitively Impaired Individuals

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    vHIT testing

    Standard of Care

    Arm 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 .

    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.

    Outcomes

    Primary Outcome Measures

    Sensitivity & Specificity of vHIT device
    Sensitivity and specificity of the vhit to detect peripheral vestibular dysfunction in an acute presentation of vertigo

    Secondary Outcome Measures

    Time to perform testing
    The time it takes to perform vHIT testing on a participant admitted for dizziness in the hospital environment.
    Predictive Value
    We will measure positive predicitive value of vHIT to determine peripheral vestibular involvement in a participant who presents with dizziness.
    Cost Analysis
    We will examine the cost reduction that would have occured if vhit was incorporated in decision making for stroke workup and/or hospital admission

    Full Information

    First Posted
    September 1, 2023
    Last Updated
    September 12, 2023
    Sponsor
    Medical University of South Carolina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06038175
    Brief Title
    vHIT Testing for Presentation of Dizziness at a Comprehensive Stroke Center
    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?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 31, 2024 (Anticipated)
    Study Completion Date
    October 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of South Carolina

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Acute, Vertigo, Vertigo, Peripheral, Dizziness, Dizziness; Syndrome

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    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.
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    vHIT testing
    Arm Type
    Experimental
    Arm 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 Title
    Standard of Care
    Arm Type
    Active Comparator
    Arm 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(s)
    Video Head Impulse Testing
    Intervention 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 .
    Intervention Type
    Other
    Intervention Name(s)
    Standard of care neurologic evaluation
    Intervention Description
    A standard neurologic evaluation will be performed including a National Institute of Health Stroke Scale and imaging if symptoms and NIHSS warrant.
    Primary Outcome Measure Information:
    Title
    Sensitivity & Specificity of vHIT device
    Description
    Sensitivity and specificity of the vhit to detect peripheral vestibular dysfunction in an acute presentation of vertigo
    Time Frame
    This will be performed once all results are compiled, not to exceed 90 days after study completion.
    Secondary Outcome Measure Information:
    Title
    Time to perform testing
    Description
    The time it takes to perform vHIT testing on a participant admitted for dizziness in the hospital environment.
    Time Frame
    From time the study team member arrives to patient's location until vHIT testing is complete, not to exceed 1 hour.
    Title
    Predictive Value
    Description
    We will measure positive predicitive value of vHIT to determine peripheral vestibular involvement in a participant who presents with dizziness.
    Time Frame
    At the time results are compared from vHIT testing to CT scan, not to exceed 30 days post testing.
    Title
    Cost Analysis
    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
    Time Frame
    This will be performed once all results are compiled, not to exceed 90 days after study completion.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults between the ages of 18-90 Admitted to the MUSC ED with symptomatic dizziness, concerning for a stroke vs peripheral vestibular dysfunction. Exclusion Criteria: Prisoners COVID + Cognitively Impaired Individuals
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christine Holmstedt, DO
    Phone
    8437923020
    Email
    Holmsted@musc.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sinead Farrelly, DPT
    Email
    farrelsi@musc.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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