NCT05190718 Register Study: Implementation of Pharyngeal Electrostimulation Therapy for the Treatment of Acute Neurogenic Dysphagia
| NCT ID | NCT05190718 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karl Landsteiner University of Health Sciences |
| Condition | Neurogenic Dysphagia |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-12-15 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2021-12-15 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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?
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Contraindication to nasogastric tube, * Unstable cardiac or respiratory condition that does not allow the insertion of the Nasogastric tube * Pacemakers * Implanted defibrillators (ICD) * Pregnant * Breastfeeding women (Caution: interfering signals may be visible in ECGs, \& EEGs with continuous recording).
Contact & Investigator
Walter Struhal, Prof. Dr.
STUDY CHAIR
University Clinic Tulln
Frequently Asked Questions
Who can join the NCT05190718 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neurogenic Dysphagia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05190718 currently recruiting?
Yes, NCT05190718 is actively recruiting participants. Contact the research team at michaela.trapl@tulln.lknoe.at for enrollment information.
Where is the NCT05190718 trial being conducted?
This trial is being conducted at Tulln, Austria.
Who is sponsoring the NCT05190718 clinical trial?
NCT05190718 is sponsored by Karl Landsteiner University of Health Sciences. The principal investigator is Walter Struhal, Prof. Dr. at University Clinic Tulln. The trial plans to enroll 100 participants.