Advancement of Vestibular Intervention via Portable Electrical Stimulator (VIPES)

Vestibular dysfunction is a debilitating impairment that often results from traumatic brain injury (TBI) and leads to increased risk of falls, inability to perform daily activities, and decreased quality of life. To help restore the vestibular function and quality of life of military members dealing with vestibular dysfunction, Vivonics and the Mayo Clinic, AZ have developed the Vestibular Intervention via Portable Electrical Stimulator (VIPES) system, a non-invasive method of treating vestibular issues using galvanic vestibular stimulation (GVS), a method of applying electrical currents to the vestibular apparatus via transdermal electrodes. In Phase I and II, Vivonics and the Mayo Clinic successfully demonstrated the feasibility of the system and tested it in an in-lab clinical trial and a clinical trial where subjects use the system outside of the laboratory setting. Our proposed work aims to refine the VIPES device wearable system designed in the Phase II which can be worn and used by vestibular disorder patients in everyday life. We aim to test this wearable system in a clinical trial at the University of Michigan Medical Center, consisting of both an in-laboratory study with a series of standardized balance tests and a pilot take-home study to evaluate the effectiveness of VIPES in allowing patients to engage in everyday activities. By the end of the proposed work, we aim to have a refined version of the VIPES device that has been clinically tested in real life scenarios and a pathway to commercialization, including a meeting with the FDA to establish the regulatory pathway for the VIPES device and a pivotal clinical trial protocol to be performed in future work. The success of this work and eventual commercialization of the VIPES system will allow for a novel, non-invasive method to treat the symptoms of patients afflicted with vestibular disorders, including military and civilians who have suffered from TBI.