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.
The lead investigator for this trial is David E. Newman-Toker, MD, PhD. He is Associate Professor of Neurology and Otolaryngology, with joint appointments in Ophthalmology, Health Sciences Informatics, and Emergency Medicine at the Johns Hopkins University School of Medicine, as well as Epidemiology and Health Policy & Management at the Bloomberg School of Public Health. Dr. Newman-Toker holds degrees from Yale University (B.S. Molecular Biophysics & Biochemistry 1991), the University of Pennsylvania, School of Medicine (M.D.1995), and the Johns Hopkins Bloomberg School of Public Health (Ph.D. Clinical Investigation 2007). He completed internship and Neurology residency at Harvard University (Massachusetts General Hospital 1999) followed by fellowships in Neuro- ophthalmology at Harvard University (Simmons Lessell, Massachusetts Eye & Ear Infirmary, 2000) and Neuro- otology at the Johns Hopkins University School of Medicine (David Zee, Johns Hopkins Hospital 2002). He joined the Department of Neurology at the Johns Hopkins University School of Medicine as faculty in 2002.
Dr. Newman-Toker's clinical interest is in diagnosis of acute disorders affecting the vestibular system and particularly in the diagnosis of acute vertigo and dizziness. His research focus is on errors in diagnosis, decision modeling, and designing clinical algorithms and decision support systems to reduce misdiagnosis in frontline healthcare settings. He has been the Principal Investigator for several federal and non-federal research grants focused on diagnosis and misdiagnosis of dizziness and other neurologic symptoms in the emergency department. Research methods employed by his group include prospective cross-sectional, observational cohort, surveys, and systematic literature reviews.
The researchers hypothesize that VOG-guided rapid triage will help accurately, safely, and efficiently differentiate peripheral from central vestibular disorders in ED patients presenting acute vertigo or dizziness, and that doing so has the potential to improve post-treatment clinical outcomes for these patients.