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NCT Number: NCT04782284

Comprehensive Swallowing Rehabilitation in Patients With MSA

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Location status: Recruiting

Location contact

Han Gil Seo, MD, PhD

CONTACT

[email protected]

82-2-2072-1659

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive swallowing rehabilitation

Other

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

Swallowing education

Other

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Han Gil Seo, MD, PhD

CONTACT

[email protected]

82-2-2072-1659

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effect of Comprehensive Swallowing Rehabilitation in Patients With Multiple System Atrophy: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2021
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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