A Comparison of an Implanted Neuroprosthesis With Sensory Training for Improving Airway Protection in Chronic Dysphagia

Objective: To determine if an implanted neuroprosthesis improves airway protection for swallowing in chronic pharyngeal dysphagia to a greater degree than sensory training. The implanted neuroprosthesis will provide intramuscular stimulation to as many as 8 hyo-laryngeal muscles. Stimulation will be coincident with a button press initiation under patient control while eating or at regular intervals for saliva swallows during the day and/or at night. Sensory training will include vibrotactile stimulation to the neck coincident with swallowing under patient control to assist with swallowing while eating or for saliva swallows during the day. Study population: Persons with chronic (greater than 6 months) dysphagia with risk of aspiration secondary to neurological injury, stroke or chronic neurological disease who currently require enteric feeding or severe dietary restrictions because of risk of aspiration. Design: A Phase 2 clinical trial with random assignment between two treatment groups with blinded assessment of treatment outcome. Both treatment groups will undergo 2 weeks of device training with a speech pathologist. The implant group will undergo training starting 3 weeks after implantation. They will receive prescriptive training when the levels of muscles stimulation will be established for swallowing. Patients will be trained to press a switch to control the stimulation while they are swallowing. The sensory training group will receive the same amount of training to provide sensory stimulation coincident with attempting to swallow. Outcome measures: Blinded assessment of risk of aspiration on videofluoroscopy using the NIH Swallowing Safety Scale, and patient administration of the Functional Oral Intake Scale (FOIS) for Dysphagia and the Swallowing Quality of Life Outcomes Tool (SWAL\_QOL) prior to treatment and at 3, 6, 9, and 12 months following treatment. Patient administration of the FOIS and SWAL\_QOL at 24-months.