• Home
• Introduction
• What is Positional Vertigo?
• Symptoms of Positional Vertigo
• Diagnosis of Positional Vertigo
• How is Positional Vertigo Treated?
• How the VertiGONE System Works
• National Institutes of Health Study
• The Background Study
• The Committee
• The Study
• Co-investigators
• National Institutes of Health Committee
• Chairperson
• Members
• Scientific Review Administrator
• Grants Technical Assistants

NIH: National Institutes of Health

The National Institutes of Health, (NIH), is the medical research arm of the U.S. Department of Health and Human Services. In 2006, the NIH awarded a grant to VertiGONE, Inc., to study the effectiveness of the VertiGONE Goggle for the relief of benign paroxysmal positional vertigo (BPPV). This was VertiGONE’s initial application and only 7% of NIH study proposals are granted on the first submission. The NIH acceptance is a major step toward approval of the VertiGONE Goggle.

The Background Study

It was observed by a consultant to VertiGONE that the accuracy and effectiveness of Epley maneuvers could be better. To determine the accuracy of Epley maneuver performance, a solid-state method of measuring and recording the head position was developed.

This device included a sensor attached to a bite block placed in a subject’s mouth. The angle of the bite block relative to the inner ear was determined using x-ray. The sensor contained solid-state accelerometers in each of 3 perpendicular planes. The bite block sensor outputs were connected to a laptop computer that converted the accelerometer input to three-dimensional position, measured in degrees.

Using this solid-state device, the accuracy of performing the Epley maneuver manually without visual guidance was measured. Fourteen technical personnel performed the Epley maneuvers in four nationally leading vestibular treatment facilities. The results were measured and then compared to the classic Epley maneuver description. The results showed routine deviation from the classic Epley maneuver, some as much as 18 degrees error per position. Immediately following this manual Epley maneuver, the subject had the VertiGONE Goggle placed and the treating personnel were instructed to perform the Epley maneuver according to the VertiGONE Goggle Professional Guide Ball instructions. The manual versus Goggle-guided Epley results showed that 13 of 14 personnel performed the Epley maneuver more accurately using the Goggle. Armed with these findings, VertiGONE enlisted four recognized vestibular experts to test whether the increased accuracy of Epley maneuver performance made a clinical difference. VertiGONE applied to the NIH to obtain funding for a national trial of the VertiGONE Goggle.

The Committee

The NIH study evaluation committee is enthusiastic about the study and the possibility of an accurate, inexpensive treatment for positional vertigo usable by a practitioner in his or her office, or by a patient at home. The evaluation committee is made up of professors from Arizona State University, University of Wisconsin, University of Minnesota, University of Michigan, University of Texas, University of Southern California, Harvard Medical School, University of Pittsburgh, Ohio State University and the University of South Florida. The committee approved the VertiGONE proposed study.

The Study

The VertiGONE Goggle study is being performed at four different medical clinics in the country and will last twelve months. The study includes 60 patients who were diagnosed with positional vertigo upon admission to the study. The co-investigators and their teams will record information related to the clinical success rate of accurate versus inaccurate Epley maneuvers for treatment of positional vertigo.

The overall goal of the study is to increase patient access to rapid treatment for benign paroxysmal positional vertigo (BPPV) by enabling the primary care practitioners to accurately perform the Epley maneuver using the VertiGONE Goggle. The VertiGONE Goggle has the potential to become a cost-effective, time-saving treatment for patients suffering from positional vertigo by providing relief for patients in a primary care practitioner’s office or at home.

The study will direct two groups of randomly assigned patients through one of two tracks: (1) in a first group of patients to perform Epley maneuvers consistently and accurately (classic Epley), and (2) in a second group of patients to perform the Epley maneuvers consistently but 20 degrees inaccurately (offset Epley). The resolution of (1) the patient’s vertigo symptoms, and (2) the resolution of the rotary nystagmus associated with positional vertigo in the Dix-Hallpike positions, is the outcome parameter.

In order to accurately perform the classic (accurate) and the 20 degrees off (inaccurate) Epley maneuvers, custom versions of the Goggle have been created. Each of the study Goggle pairs will have had the Goggle professional guide ball indicators set using the solid-state apparatus. The data obtained from the use of each Goggle with patients will be used to determine whether the increased accuracy of the VertiGONE Goggle improves the clinical treatment outcomes.

No pretreatment for BPPV has been administered prior to entering the study. Each patient will undergo a first and second therapy session and a third observation visit, each separated by approximately one week. The Goggle set for a classic Epley maneuver (Goggle I) and the Goggle set for 20 degrees off the classic Epley maneuver (Goggle II) was randomly assigned to patients for use in the first therapy session. At the second therapy session, the other Goggle is used. Before treatment sessions one and two and at observation visit three, the patient will be observed for rotary nystagmus. During the one week periods after each treatment session, the patient will keep a daily log of subjective 0-100% improvement or 0-100% worsening in their vertigo. The patients will not know which of the two Goggle designs they are using nor which Goggle is classic and which is 20 degrees off classic. Clinical personnel performing the Epley maneuver will not know this information, either. Goggle designs were identified as Goggle I and Goggle II to allow clinical assistants to select the correct Goggle for the follow-up session; for example, if Goggle I is used in the initial session, then Goggle II is used in the follow-up and vice versa as dictated by the randomization schedule.

Co-investigators

Three leading ear specialists and a Ph.D. in physical therapy in four different medical sites agreed to study the Goggle in this NIH approved study. Philip F. Anthony, M.D., an otologist in Fort Worth, Texas, is the principal investigator. The co-investigators are Jay B. Farrior, M.D., an otologist in Tampa, Florida, Mitchell K. Schwaber, M.D., an otologist/neurotologist in Nashville, Tennessee, and Debra Cooke, PT, Ph.D., a physical therapist from Kansas City, Missouri.