Dr. David Newman-Toker and the Brain Injury Outcomes (BIOS) coordinating center at Johns Hopkins University are happy to announce that The National Institute on Deafness and Other Communication Disorders (NIDCD), one of the National Institutes of Health (NIH), has awarded funding for the AVERT clinical trial (FAIN U01DC013778). AVERT (Acute Video-oculography for vertigo in Emergency rooms for Rapid Triage) is a randomized controlled trial evaluating the algorithmic application of a diagnostic medical device (video-oculography or VOG) in the triage of patients presenting to hospital emergency departments with vertigo and dizziness.
The study is expected to randomize 226 patients across 3 U.S.-based clinical sites. The study has been deemed a non-significant risk device trial by the U.S. FDA as it involves a new (investigational) application of this device. VOG devices are currently FDA-approved for measuring eye movements in the assessment of vestibular conditions; they have not been used extensively in the emergency department setting prior to this trial. The study is currently under review by the Institutional Review Boards at the participating sites and is expected to start enrolling next year.