Using Pharyngeal Electrostimulation to Treat Swallowing Difficulties from Neurological Conditions
Register Study: Implementation of Pharyngeal Electrostimulation Therapy for the Treatment of Acute Neurogenic Dysphagia
This study is testing a new device called Phagenyx® to see if it can help people with swallowing difficulties caused by neurological conditions like stroke or brain injury.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karl Landsteiner University of Health Sciences Academic / other |
| Locations | 1 site (Tulln, Low Austria) |
| Trial ID | NCT05190718 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the implementation of pharyngeal electrostimulation therapy for patients suffering from neurogenic dysphagia, a condition often resulting from neurological diseases such as stroke, traumatic brain injury, and long COVID-19. The study aims to evaluate the effectiveness of the Phagenyx® device, which has shown promise in improving swallowing function in patients who are difficult to treat with conventional methods. Participants will undergo standardized assessments to determine their eligibility and the impact of the therapy on their swallowing capabilities and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with neurogenic dysphagia resulting from conditions like stroke, traumatic brain injury, or Parkinson's disease.
Not a fit: Patients with unstable cardiac or respiratory conditions, or those who are pregnant or breastfeeding, may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve swallowing function and quality of life for patients with neurogenic dysphagia.
How similar studies have performed: Other studies have shown positive outcomes with pharyngeal electrostimulation, indicating that this approach is promising and not entirely novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Tulln, Low Austria
- University Clinic Tulln — Tulln, Low Austria, Austria (Recruiting)
Study contacts
- Study coordinator: Michaela Trapl-Grundschober, MAS, MSc
- Email: michaela.trapl@tulln.lknoe.at
- Phone: +43 2272900422393
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.