vHIT Testing for Presentation of Dizziness at a Comprehensive Stroke Center

Not Applicable

Completed

• Conditions: Dizziness; Syndrome; Stroke, Acute; Dizziness; Vertigo, Peripheral; Vertigo
• Interventions: Other: Standard of care neurologic evaluation; Device: Video Head Impulse Testing

• Registration Number: NCT06038175
• Lead Sponsor: Medical University of South Carolina

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.

Study Timeline

• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-12
• Study First Posted: 2023-09-14
• Study Start: 2024-01-16
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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Exclusion Criteria

• Prisoners
• COVID +
• Cognitively Impaired Individuals

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of care neurologic evaluation	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.
vHIT testing	Video Head Impulse Testing	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 .
vHIT testing	Standard of care neurologic evaluation	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 .

Primary Outcome Measures

Name	Time	Method
Sensitivity & Specificity of vHIT device	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 Outcome Measures

Name	Time	Method
Cost Analysis	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
Time to perform testing	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.
Predictive Value	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.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States