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

Summary

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?

Conditions

• Neurogenic Dysphagia
• Traumatic Brain Injury
• Stroke
• Dysphagia
• Long Covid-19
• Intubation Complication
• Polyradiculitis

Interventions

DEVICE

Pharyngeal electrostimulation

Routine treatment: Pharyngeal stimulation is performed via a nasogastric probe (Phagenyx) for a duration of 10 minutes daily and for at least 3 consecutive days. The number of stimulation repeats until max 2x3 repeats, depends on therapy progress and an interdisciplinary re-evaluation of the patient's rehabilitation potential.

Sponsors & Collaborators

• Universitätsklinikum Tulln

  collaborator UNKNOWN

• Karl Landsteiner University of Health Sciences

  lead OTHER

Principal Investigators

• Walter Struhal, Prof. Dr. · University Clinic Tulln

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-15

Primary Completion

2025-12-01

Completion

2026-12-30

Countries

• Austria

Study Locations