Multiple System AtrophyNCT04782284
Comprehensive Swallowing Rehabilitation in Patients With MSA
A study testing Comprehensive swallowing rehabilitation and Swallowing education in people with Multiple System Atrophy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the effect of comprehensive swallowing rehabilitation in patients with multiple system atrophy. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Multiple System Atrophy
- What is being tested?
- Comprehensive swallowing rehabilitation and Swallowing education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 May 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Han Gil Seo, MD, PhD, 82-2-2072-1659, hgseo80@gmail.com
About this study
Official title: Effect of Comprehensive Swallowing Rehabilitation in Patients With Multiple System Atrophy: A Randomized Controlled Trial
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.
- Conditions
- Multiple System Atrophy
- Being tested
- Comprehensive swallowing rehabilitation, Swallowing education
- Keywords
- Multiple System Atrophy, Dysphagia, Swallowing rehabilitation, Videofluoroscopic Swallowing Study
- Medical subject headings
- Multiple System Atrophy, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive swallowing rehabilitationOther
The treatment time per session is 30 minutes. Total 12 sessions are provided for 6 weeks.
Swallowing educationOther
The education is 30 minutes. Total 1 session is provided immediately after baseline evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive swallowing rehabilitation | Experimental | Not described Receives: Other: Comprehensive swallowing rehabilitation |
| Swallowing education | Active comparator | Not described Receives: Other: Swallowing education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetration-Aspiration Scale
Measured: at 6 weeks
Videofluoroscopic dysphagia scale
Measured: at 6 weeks
Secondary outcomes (10)
Penetration-Aspiration Scale
Measured: at 12 weeks
Videofluoroscopic dysphagia scale
Measured: at 12 weeks
Peak Cough Flow
Measured: at 6 weeks, at 12 weeks
Maximal Inspiratory Pressure
Measured: at 6 weeks, at 12 weeks
Maximal Expiratory Pressure
Measured: at 6 weeks, at 12 weeks
Forced vital capacity
Measured: at 6 weeks, at 12 weeks
Forced expiratory volume
Measured: at 6 weeks, at 12 weeks
Maximal phonation time
Measured: at 6 weeks, at 12 weeks
Swallowing disturbance questionnaire
Measured: at 6 weeks, at 12 weeks
Swallowing Quality of Life questionnaire
Measured: at 6 weeks, at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start17 May 2021
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System AtrophyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Gil Seo, Seoul National University Hospital
- Investigators
- Han Gil Seo, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782284
- Sponsor's protocol ID
- MSA-swrehab-RCT
- Status last verified
- Apr 2026
- First submitted
- 1 Mar 2021
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Comprehensive Swallowing Rehabilitation in Patients With Multiple System Atrophy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04782284
- Acronym / sponsor ID
- MSA-swrehab-RCT
- Conditions
- Multiple System Atrophy
- Keywords
- Multiple System Atrophy, Dysphagia, Swallowing rehabilitation, Videofluoroscopic Swallowing Study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effect of comprehensive swallowing rehabilitation in patients with multiple system atrophy.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Comprehensive swallowing rehabilitation | Experimental | Other: Comprehensive swallowing rehabilitation |
| Swallowing education | Active comparator | Other: Swallowing education |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive swallowing rehabilitationThe treatment time per session is 30 minutes. Total 12 sessions are provided for 6 weeks. | Other | Comprehensive swallowing rehabilitation |
| Swallowing educationThe education is 30 minutes. Total 1 session is provided immediately after baseline evaluation. | Other | Swallowing education |
Primary outcome
Penetration-Aspiration Scale
Time frame: at 6 weeks
Videofluoroscopic dysphagia scale
Time frame: at 6 weeks
10 secondary outcomes
Penetration-Aspiration Scale
Time frame: at 12 weeks
Videofluoroscopic dysphagia scale
Time frame: at 12 weeks
Peak Cough Flow
Time frame: at 6 weeks, at 12 weeks
Maximal Inspiratory Pressure
Time frame: at 6 weeks, at 12 weeks
Maximal Expiratory Pressure
Time frame: at 6 weeks, at 12 weeks
Forced vital capacity
Time frame: at 6 weeks, at 12 weeks
Forced expiratory volume
Time frame: at 6 weeks, at 12 weeks
Maximal phonation time
Time frame: at 6 weeks, at 12 weeks
Swallowing disturbance questionnaire
Time frame: at 6 weeks, at 12 weeks
Swallowing Quality of Life questionnaire
Time frame: at 6 weeks, at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Han Gil Seo, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive swallowing rehabilitation and Swallowing education in people with Multiple System Atrophy, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Han Gil Seo, MD, PhD (82-2-2072-1659, hgseo80@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration-Aspiration Scale (time frame: at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.