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Completed

NCT Number: NCT06038175

vHIT Testing for Presentation of Dizziness at a Comprehensive Stroke Center

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.

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Disease Dizziness Dizziness; Syndrome Ear Diseases Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Stroke Syndrome Vascular Diseases Vertigo Vertigo, Peripheral Vestibular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video Head Impulse Testing

Device

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 .

Standard of care neurologic evaluation

Other

A standard neurologic evaluation will be performed including a National Institute of Health Stroke Scale and imaging if symptoms and NIHSS warrant.

Primary outcomes

  1. Sensitivity & Specificity of vHIT device

    Time frame: This will be performed once all results are compiled, not to exceed 90 days after study completion.

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

Secondary outcomes

  1. 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.

    The time it takes to perform vHIT testing on a participant admitted for dizziness in the hospital environment.

  2. Predictive Value

    Time frame: At the time results are compared from vHIT testing to CT scan, not to exceed 30 days post testing.

    We will measure positive predicitive value of vHIT to determine peripheral vestibular involvement in a participant who presents with dizziness.

  3. Cost Analysis

    Time frame: This will be performed once all results are compiled, not to exceed 90 days after study completion.

    We will examine the cost reduction that would have occured if vhit was incorporated in decision making for stroke workup and/or hospital admission

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study 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?

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 14, 2023
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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