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RecruitingNCT04782284Updated Apr 27, 2026

Comprehensive Swallowing Rehabilitation in Patients With MSA

An interventional study of Comprehensive swallowing rehabilitation and Swallowing education in Multiple System Atrophy, sponsored by Seoul National University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2021; still recruiting 5 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

The purpose of this study is to investigate the effect of comprehensive swallowing rehabilitation in patients with multiple system atrophy.

Read the detailed description

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.

02

Conditions studied

  • Multiple System Atrophy

Keywords

  • Multiple System Atrophy
  • Dysphagia
  • Swallowing rehabilitation
  • Videofluoroscopic Swallowing Study
03

In context

Multiple System Atrophy

207 studies on the registry are indexed under Multiple System Atrophy; 73 are open to participants now.

This study's planned enrollment of 24 is below the median of 41 across 134 interventional studies indexed under Multiple System Atrophy.

Browse Multiple System Atrophy studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Moderate to severe cognitive dysfunction with score \< 19
  • Comorbidities or structural abnormalities that may affect swallowing function
  • Other comorbidities that make it difficult to participate in the study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Comprehensive swallowing rehabilitation

    Other: Comprehensive swallowing rehabilitation

  • Active comparator
    Swallowing education

    Other: Swallowing education

Interventions

  • OtherComprehensive swallowing rehabilitation

    The treatment time per session is 30 minutes. Total 12 sessions are provided for 6 weeks.

  • OtherSwallowing education

    The education is 30 minutes. Total 1 session is provided immediately after baseline evaluation.

06

What researchers measure

Primary outcomes

  1. Penetration-Aspiration Scale

    Time frame: at 6 weeks

  2. Videofluoroscopic dysphagia scale

    Time frame: at 6 weeks

Secondary outcomes

  1. Penetration-Aspiration Scale

    Time frame: at 12 weeks

  2. Videofluoroscopic dysphagia scale

    Time frame: at 12 weeks

  3. Peak Cough Flow

    Time frame: at 6 weeks, at 12 weeks

  4. Maximal Inspiratory Pressure

    Time frame: at 6 weeks, at 12 weeks

  5. Maximal Expiratory Pressure

    Time frame: at 6 weeks, at 12 weeks

  6. Forced vital capacity

    Time frame: at 6 weeks, at 12 weeks

  7. Forced expiratory volume

    Time frame: at 6 weeks, at 12 weeks

  8. Maximal phonation time

    Time frame: at 6 weeks, at 12 weeks

  9. Swallowing disturbance questionnaire

    Time frame: at 6 weeks, at 12 weeks

  10. Swallowing Quality of Life questionnaire

    Time frame: at 6 weeks, at 12 weeks

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04782284
Responsible party
Han Gil Seo (Associate Professor, Seoul National University Hospital) — Principal investigator
First posted
Mar 4, 2021
Start date
May 17, 2021
Primary completion
Oct 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Apr 27, 2026

Study contacts

Han Gil Seo, MD, PhD
Contact
hgseo80@gmail.com
82-2-2072-1659
Han Gil Seo, MD, PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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