Pharyngeal Electrostimulation Therapy for Moderate to Severe Neurogenic Dysphagia in Adults A Register Study Evaluating Treatment Outcomes and Rehabilitation Potential

What this Trial Is About

Neurogenic dysphagia is a condition caused by disruption of the neurological systems that control safe and coordinated swallowing. It commonly affects patients with neurological diseases, especially those treated in Intensive Care Units who are intubated or tracheotomised. This condition is serious and can lead to complications such as aspiration pneumonia, malnutrition, and reduced quality of life. The trial aims to evaluate the use of pharyngeal electrostimulation therapy, delivered via the Phagenyx medical device, in patients with moderate to severe neurogenic dysphagia to understand its impact on swallowing outcomes and recovery time. The study involves the use of the Phagenyx device, which is a nasogastric probe equipped with stimulation electrodes. The therapy consists of daily 10-minute pharyngeal electrostimulation sessions for at least three consecutive days, with up to six treatments depending on patient progress. The stimulation intensity is tailored for cooperative patients, while a standard setting is used for non-cooperative patients. The device also serves as a feeding tube and remains in place during treatment. Treatment sessions are scheduled to occur ideally on consecutive days with specific timing rules to ensure effectiveness and safety. Participants will undergo systematic assessments before, during, and after the therapy. These include clinical swallowing screenings, scores like the Dysphagia Severity Rating Scale DSRS, Penetration Aspiration Scale PAS, and instrumental evaluations using Fibreoptic Endoscopic Evaluation of Swallowing FEES. Neurological status will also be monitored using scales such as the modified Ranking Scale and NIH Stroke Scale. Data collection will continue up to one year to observe changes in dysphagia severity and swallowing function. Patient progress and safety are closely monitored throughout the therapy and until hospital discharge.

Register Study: Implementation of Pharyngeal Electrostimulation Therapy for the Treatment of Acute Neurogenic Dysphagia