Dizziness, Dizziness; Syndrome, Stroke, Acute, Vertigo, Vertigo, Peripheral
Conditions
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.
Interventions
DEVICEVideo Head Impulse Testing
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 .
OTHERStandard of care neurologic evaluation
A standard neurologic evaluation will be performed including a National Institute of Health Stroke Scale and imaging if symptoms and NIHSS warrant.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
United States
Outcome results
None listed