vHIT Testing for Presentation of Dizziness at a Comprehensive Stroke Center

Stroke, Acute Clinical Trial

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?

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06038175
• Other study ID #: Pro00129771
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 16, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: January 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Dizziness
• Stroke
• Stroke, Acute
• Vertigo
• Vertigo, Peripheral

Intervention

Device:
• Video 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 .

Other:
• Standard 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity & Specificity of vHIT device	Sensitivity and specificity of the vhit to detect peripheral vestibular dysfunction in an acute presentation of vertigo	This will be performed once all results are compiled, not to exceed 90 days after study completion.
Secondary	Time to perform testing	The time it takes to perform vHIT testing on a participant admitted for dizziness in the hospital environment.	From time the study team member arrives to patient's location until vHIT testing is complete, not to exceed 1 hour.
Secondary	Predictive Value	We will measure positive predicitive value of vHIT to determine peripheral vestibular involvement in a participant who presents with dizziness.	At the time results are compared from vHIT testing to CT scan, not to exceed 30 days post testing.
Secondary	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	This will be performed once all results are compiled, not to exceed 90 days after study completion.