Abstract 30: Pharyngeal Electric Stimulation: The Initial U.S. Experience With a Novel Device for Treatment of Severe Dysphagia After Stroke

Abstract

Background: Based on over 20 years of international research, FDA recently granted De Novo classification to the Phagenyx® Neurostimulation System for pharyngeal electrical stimulation (PES) for patients with severe dysphagia post stroke. Subjects & Methods: We report on the design and outcomes of the first U.S. post market multi-center experience with the Phagenyx® Neurostimulation System (Phagenesis Limited, Manchester, UK). Eligible patients were determined to have severe dysphagia post-stroke (ischemic or hemorrhagic) by the treating stroke neurologists (MD) and standard assessments by Speech-Language Pathologists (SLPs). Treatment was implemented in addition to standard of care during hospitalization with institutional informed consents obtained prior to treatment. PES stimulation levels were optimized for each patient and each treatment through sensory threshold and tolerance testing by the SLPs. This was followed by a fixed 10 minute treatment session. The treatment regimen was: 1 treatment per day, 10 min/day x 3 days with interim speech therapy reassessment. Treatment could be extended up to 3 additional treatments for a total of 6 treatments if deemed necessary by medical team. SLPs monitored for adverse events during the optimization and treatment. Results: PES was administered to a minimum of 5 patients at each participating institution during the initial implementation. An instrumental assessment was completed at the conclusion of the treatment period as indicated, showing outcomes that ranged from improved secretion management and diet advancement, to swallow restoration. Patient experiences and suggestions were captured and will be presented. Conclusions: A novel FDA-approved PES device for treatment of severe dysphagia shows a potential to be safely tolerated with the magnitude of swallowing improvement and restoration similar to the pivotal trials conducted overseas. Final results of the multi-center study will be presented at the meeting.