Actively Recruiting

Age: 18Years +
All Genders
ID05190718

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

56 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 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.

CONDITIONS

Brief 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 ischaemic or haemorrhagic stroke, polyradiculitis, Parkinson's disease, multiple sclerosis, dementia, traumatic brain injury, or post Covid-19
  • Age 18 years or older
  • Patients showing potential for rehabilitation
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - At least 3 consecutive days with up to 6 treatment sessions

Participants receive pharyngeal electrostimulation therapy via a nasogastric probe (Phagenyx®) as part of routine treatment for neurogenic dysphagia. Therapy sessions last 10 minutes daily for at least 3 consecutive days, with up to 6 treatments depending on therapy progress and patient assessment.

Daily treatment visits for at least 3 days

Long-term Monitoring

Duration - Until hospital discharge (variable duration)

Participants are monitored and re-examined using swallowing and neurological assessments before discharge to document long-term effects of the therapy.

1 final visit before discharge

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

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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Published Research Related To This Trial

Pharyngeal electrical stimulation for neurogenic dysphagia following stroke, traumatic brain injury or other causes: Main results from the PHADER cohort study.

Philip M Bath, Lisa J Woodhouse, Sonja Suntrup-Krueger...

https://pubmed.ncbi.nlm.nih.gov/33294818

Laryngeal Injury and Upper Airway Symptoms After Oral Endotracheal Intubation With Mechanical Ventilation During Critical Care: A Systematic Review.

Martin B Brodsky, Matthew J Levy, Erin Jedlanek...

https://pubmed.ncbi.nlm.nih.gov/30096101

Prevalence, Pathophysiology, Diagnostic Modalities, and Treatment Options for Dysphagia in Critically Ill Patients.

Martin B Brodsky, Joeke L Nollet, Peter E Spronk...

https://pubmed.ncbi.nlm.nih.gov/32304381

Design and implementation of Pharyngeal electrical Stimulation for early de-cannulation in TRACheotomized (PHAST-TRAC) stroke patients with neurogenic dysphagia: a prospective randomized single-blinded interventional study.

Rainer Dziewas, Satish Mistry, Shaheen Hamdy...

https://pubmed.ncbi.nlm.nih.gov/27807279

Pharyngeal electrical stimulation for early decannulation in tracheotomised patients with neurogenic dysphagia after stroke (PHAST-TRAC): a prospective, single-blinded, randomised trial.

Rainer Dziewas, Rebecca Stellato, Ingeborg van der Tweel...

https://pubmed.ncbi.nlm.nih.gov/30170898

Therapy of Dysphagia by Prolonged Pharyngeal Electrical Stimulation (Phagenyx) in a Patient with Brainstem Infarction.

Cristina Florea, Christine Bräumann, Christine Mussger...

https://pubmed.ncbi.nlm.nih.gov/32353976