NCT05190718: R:IphEst

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

Recruiting now Last updated 7 March 2025

What this trial tests

trial testing Pharyngeal electrostimulation in Neurogenic Dysphagia in 100 participants. Currently enrolling.

Timeline

15 December 2021

Primary endpoint
1 December 2025

30 December 2026

Quick facts

Lead sponsor	Karl Landsteiner University of Health Sciences
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	100
Start date	15 December 2021
Primary completion	1 December 2025
Estimated completion	30 December 2026
Sites	1 location across Austria

Drugs / interventions tested

• Pharyngeal electrostimulation

Conditions studied

• Neurogenic Dysphagia — all drugs for Neurogenic Dysphagia →
• Traumatic Brain Injury — all drugs for Traumatic Brain Injury →
• Stroke — all drugs for Stroke →
• Dysphagia — all drugs for Dysphagia →

Sponsor

Karl Landsteiner University of Health Sciences

Who can join

18 and older, any sex, with Neurogenic Dysphagia or Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Neurogenic dysphagia occurs with disruption of neurological systems or processes involved in the execution of coordinated and safe swallowing. It is common in patients with neurological diseases, in particular in patients treated in Intensive Care Units (ICU) who are intubated (up to 62%) and / or tracheotomised (up to 83%). Dysphagia is one of the most common and most dangerous symptoms of many neurological diseases. In addition, neurogenic dysphagia can have a significant impact on quality of life, medication efficacy, and malnutrition.

Dysphagia is currently treated conservatively on evidence-based exercises, individually adapted to each patient. In the recent years pharyngeal electrostimulation has been established and shown a positive impact on outcome. In fact, this type of therapy has not only become an addition to the existing therapy, but an important alternative for patients difficult to treat by other means.

The Phagenyx® is a medical device, which has lately been used more frequently in multiple hospitals for treatment of neurogenic dysphagia. For nearly two decades pharyngeal electrostimulation has been further developed and optimised. This therapy initiates changes in the swallowing motor cortex through neuroplasticity as well as local changes in peripheral sensory architecture associated with swallowing. Bath and colleagues (2020) recently reported the efficacy of pharyngeal electrostimulation (Phagenyx®) in various neurological conditions.

As a result, of current published studies, the use of pharyngeal electrostimulation probe, in selected patients, with neurological diseases with moderate to severe neurogenic dysphagia will be evaluated.

This trial will initially start as quality assurance project with the aim to extent it into a monocentric based register study.

The Investigators aim to validate the effectiveness of pharyngeal electrostimulation for the treatment of moderate to severe neurogenic dysphagia by systematically recording specific dysphagia-relevant parameters. At present, it is still uncertain to what extent patients with neurogenic dysphagia in the context of a non-acute neurological disease could benefit from this method.

The research questions:

Does the use of the pharyngeal electrostimulation probe have an influence on the outcome of dysphagia in patients with moderate to severe neurogenic dysphagia? How long after therapy, can the use of the pharyngeal electrostimulation probe lead to oral food intake and/or removal of a tracheal cannula?

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Evaluating the Therapeutic Application of Neuromodulation in the Human Swallowing System.
   Cheng I, Sasegbon A, Hamdy S. · · 2023 · cited 3× · PMID 36239821 · DOI 10.1007/s00455-022-10528-z