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Procedure

vHIT testing for Stroke

N/A
Waitlist Available
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Admitted to the MUSC ED with symptomatic dizziness, concerning for a stroke vs peripheral vestibular dysfunction.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this will be performed once all results are compiled, not to exceed 90 days after study completion.
Awards & highlights

Study Summary

This trial aims to test a device called video head impulse test (vHIT) to see how well it can identify different causes of vertigo in patients who come to the emergency department. The device

Who is the study for?
This trial is for adults aged 18-90 who arrive at the MUSC Emergency Department with dizziness that might indicate a stroke or peripheral vestibular dysfunction. It's not suitable for those who don't meet these specific conditions.Check my eligibility
What is being tested?
The study is testing how well the video head impulse test (vHIT) can tell apart strokes from inner ear issues when patients come in dizzy. They're checking if vHIT agrees with current tests, affects treatment like clot-busting drugs, and maybe cuts hospital stays and costs.See study design
What are the potential side effects?
Since this trial involves diagnostic procedures rather than medications, side effects are minimal but may include discomfort during the vHIT or standard neurological evaluations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was admitted to the emergency department for severe dizziness, possibly due to a stroke or inner ear issue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this will be performed once all results are compiled, not to exceed 90 days after study completion.
This trial's timeline: 3 weeks for screening, Varies for treatment, and this will be performed once all results are compiled, not to exceed 90 days after study completion. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sensitivity & Specificity of vHIT device
Secondary outcome measures
Cost Analysis
Predictive Value
Time to perform testing

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: vHIT testingExperimental Treatment2 Interventions
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 II: Standard of CareActive Control1 Intervention
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.

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Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
934 Previous Clinical Trials
7,394,766 Total Patients Enrolled
67 Trials studying Stroke
60,021 Patients Enrolled for Stroke

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being enrolled for this study?

"According to the data available on clinicaltrials.gov, this particular study is no longer actively seeking participants. It was initially posted on January 16, 2024 and last updated on January 29, 2024. However, it's worth noting that there are currently 1110 other studies accepting candidates for participation at this time."

Answered by AI

Is the age criterion for this study inclusive of individuals who are older than 35?

"For this clinical trial, individuals aged 18 to 90 are eligible for enrollment. It's worth noting that there are currently 43 ongoing trials specifically targeting patients under the age of 18 and 1078 trials focused on participants over the age of 65."

Answered by AI

Am I eligible to be a participant in this clinical trial?

"This research aims to enroll 30 individuals aged between 18 and 90 who experience peripheral vertigo. In addition, participants must meet the following conditions: They must have been admitted to the MUSC ED with symptomatic dizziness that raises concerns about stroke or peripheral vestibular dysfunction. The study is open to adults in the age range of 18-90 years old."

Answered by AI
~17 spots leftby Oct 2024