ClinicalTrials.gov record NCT04782284
Comprehensive Swallowing Rehabilitation in Patients With MSA
Effect of Comprehensive Swallowing Rehabilitation in Patients With Multiple System Atrophy: A Randomized Controlled Trial
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This randomized trial compares a 6-week comprehensive swallowing rehabilitation program with a single-session swallowing education for people with Multiple System Atrophy who have swallowing problems. The rehabilitation arm receives twelve 30‑minute sessions over six weeks; the education arm receives one 30‑minute session after baseline assessment. Key outcomes are measured at 6 and 12 weeks using swallowing studies and breathing and voice tests.
What it is studying. The study compares a structured 6‑week comprehensive swallowing rehabilitation program with a single 30‑minute swallowing education session to assess effects on swallowing safety and function in people with Multiple System Atrophy.
What the researchers hope to learn. To evaluate whether comprehensive swallowing rehabilitation changes measures of swallowing safety and severity (Penetration‑Aspiration Scale and Videofluoroscopic Dysphagia Scale) and to collect respiratory and voice-related outcomes (peak cough flow, lung volumes, maximal inspiratory/expiratory pressures, maximal phonation time) and patient-reported swallowing questionnaires at 6 and 12 weeks.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
The purpose of this study is to investigate the effect of comprehensive swallowing rehabilitation in patients with multiple system atrophy.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- Comprehensive swallowing rehabilitation
- Swallowing education
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
Multiple system atrophy (MSA) is a rapidly progressive neurodegenerative disease characterized by parkinsonism, cerebellar syndrome, and autonomic failure. Dysphagia is a clinically significant symptom leading to pneumonia that causes death in patients with MSA. Although the symptoms of dysphagia in the two subtypes of MSA-the parkinsonian variant and the cerebellar variant- are different, there is no significant difference in the latency to onset of tube feeding. Therefore, effective intervention is needed to improve the safety and efficiency of swallowing regardless of the subtypes of MSA. Although swallowing rehabilitation has been widely applied for swallowing disorders in patients with MSA, few studies have reported the clinical effect of applying swallowing therapy. Comprehensive swallowing rehabilitation has focused on functional muscle training, compensatory swallowing maneuvers, and thermal-tactile stimulation, which is used to treat dysphagia from stroke, Parkinson's disease, and head and neck cancer. Therefore, this study aims to investigate the effect of comprehensive swallowing rehabilitation in patients with MSA.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
After a baseline evaluation, participants are randomly assigned to either comprehensive swallowing rehabilitation (30-minute sessions, 12 sessions over 6 weeks) or a single 30-minute swallowing education session given after baseline. Assessments include videofluoroscopic swallowing studies (VFSS) and the Penetration‑Aspiration Scale at 6 weeks (primary) and again at 12 weeks, plus breathing and voice tests (peak cough flow, lung volumes, respiratory pressures, maximal phonation time) and swallowing questionnaires at 6 and 12 weeks. Participation will require attending therapy or assessment visits and completing the tests and questionnaires listed above.
How the study is structured. Randomized, parallel two-group trial with single masking (outcomes assessors are masked). Participants are assigned to either 12 therapy sessions over 6 weeks or one 30‑minute education session. Assessments include videofluoroscopic swallowing studies and respiratory/voice measures at baseline, 6 weeks, and 12 weeks.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in South Korea. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on multiple system atrophy
Important dates
- Study start
- May 17, 2021
- Primary completion
- Oct 31, 2027 (estimated)
- Study completion
- Dec 31, 2027 (estimated)
- Target enrollment
- 24 participants (estimated)
- Last updated on registry
- Apr 27, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Seoul National University Hospital
- Principal investigator
- Han Gil Seo, Associate Professor
Seoul National University Hospital
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Han Gil Seo, MD, PhD 📞 82-2-2072-1659 ✉ hgseo80@gmail.com
Participating sites (1)
- Seoul National University HospitalRecruiting
Seoul, 03080 · South Korea
- Han Gil Seo, MD, PhD · 82-2-2072-1659 · hgseo80@gmail.com
Terms used on this page · explanations by MedicalUpdates.ai
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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