Actively Recruiting

Age: 18Years +
All Genders
NCT05190718

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

Led by Karl Landsteiner University of Health Sciences · Updated on 2025-03-07

100

Participants Needed

1

Research Sites

263 weeks

Total Duration

On this page

Sponsors

K

Karl Landsteiner University of Health Sciences

Lead Sponsor

U

Universitätsklinikum Tulln

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of neurogenic dysphagia including ischemic and hemorrhagic strokes, polyradiculitis, Parkinson's disease, multiple sclerosis, dementia, traumatic brain injury, or post Covid-19
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Contraindication to nasogastric tube placement
  • Unstable cardiac or respiratory condition preventing nasogastric tube insertion
  • Presence of pacemakers or implanted defibrillators (ICD)
  • Pregnant or breastfeeding women
  • Possible interference with ECG or EEG recordings due to the device

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University Clinic Tulln

Tulln, Low Austria, Austria, 3430

Actively Recruiting

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Research Team

M

Michaela Trapl-Grundschober, MAS, MSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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