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Tests pharyngeal electrical stimulation for severe swallowing trouble after brain or nerve disease

Studies a throat stimulation device in adults with neurogenic swallowing difficulty and brain injury.

Plain-language title generated from the registry record
Registry title: Register Study: Implementation of Pharyngeal Electrostimulation Therapy for the Treatment of Acute Neurogenic Dysphagia

Key facts

Where
Tulln, AustriaSee the site

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Source: NCT05190718, who can take part

Where in Austria

  • University Clinic TullnTulln, AustriaTaking people

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Trial details

Who runs it
Karl Landsteiner University of Health Sciences
Trial code
NCT05190718
Record updated
7 March 2025
Original 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.Read full original descriptionShow less

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

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?

Inclusion: Neurogenic dysphagia; Ischaemic and haemorrhagic strokes; Infra- as well as supra-tentorial; Polyradiculitis; Parkinson's disease; Multiple sclerosis; Dementia; Traumatic brain injury; Post Covid-19 pat; patients over the age of 18.

Exclusion: Unstable cardiac or respiratory condition that does not allow the insertion of the Nasogastric tube; Contraindication to nasogastric tube,; Pacemakers; Implanted defibrillators (ICD); Pregnant; Breastfeeding women; (Caution: interfering signals may be visible in ECGs, \& EEGs with continuous recording).

ClinicalTrials.gov NCT05190718