Swallowing rehabilitation for patients with multiple system atrophy
Effect of Comprehensive Swallowing Rehabilitation in Patients With Multiple System Atrophy: A Randomized Controlled Trial
This study is testing a swallowing rehabilitation program to see if it can help people with multiple system atrophy improve their swallowing safety and efficiency.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04782284 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of comprehensive swallowing rehabilitation on patients diagnosed with multiple system atrophy (MSA), a neurodegenerative disease that often leads to dysphagia. The rehabilitation program includes functional muscle training, compensatory swallowing maneuvers, and thermal-tactile stimulation, aimed at improving swallowing safety and efficiency. The study will assess the clinical impact of these interventions on patients with varying subtypes of MSA, regardless of their specific swallowing challenges. Participants will undergo a Videofluoroscopic Swallowing Study to evaluate their swallowing function before and after the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults over 19 years old, clinically diagnosed with MSA and dysphagia, and who have specific findings on a recent swallowing study.
Not a fit: Patients with moderate to severe cognitive dysfunction or other comorbidities affecting swallowing may not benefit from this study.
Why it matters
Potential benefit: If successful, this rehabilitation approach could significantly enhance the quality of life and safety for patients with MSA by reducing the risk of aspiration pneumonia.
How similar studies have performed: While swallowing rehabilitation has been applied in various conditions, few studies have specifically evaluated its effectiveness in MSA, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>19 years * Clinically diagnosed with MSA according to the guidelines of the 2nd consensus of the Gilman criteria * Clinically diagnosed to have dysphagia by a physiatrist * Two or more points on the Penetration-aspiration scale (PAS) from the Videofluoroscopic swallowing study (VFSS) conducted within 3 months Exclusion Criteria: * Moderate to severe cognitive dysfunction with Mini-mental State Examination score \< 19 * Comorbidities or structural abnormalities that may affect swallowing function * Other comorbidities that make it difficult to participate in the study
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Han Gil Seo, MD, PhD — Seoul National University Hospital
- Study coordinator: Han Gil Seo, MD, PhD
- Email: hgseo80@gmail.com
- Phone: 82-2-2072-1659
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.