vHIT Testing for Presentation of Dizziness at a Comprehensive Stroke Center

NCT ID: NCT06038175

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-16
• Study Completion Date: 2024-07-31

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.

Conditions

Stroke, Acute; Vertigo; Vertigo, Peripheral; Dizziness; Dizziness; Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

vHIT 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 .

Group Type: EXPERIMENTAL

Video Head Impulse Testing

Intervention Type: 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

Intervention Type: OTHER

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

Standard of Care

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.

Group Type: ACTIVE_COMPARATOR

Standard of care neurologic evaluation

Intervention Type: OTHER

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

Interventions

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 .

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Christine Holmstedt

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

Pro00129771

Identifier Type: -

Identifier Source: org_study_id