Comprehensive Swallowing Rehabilitation in Patients With MSA

• ClinicalTrials.gov Identifier: NCT04782284
• Recruitment Status: Recruiting
• First Posted: March 4, 2021
• Last Update Posted: October 26, 2022
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Han Gil Seo, Seoul National University Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Multiple System Atrophy	Other: Comprehensive swallowing rehabilitation; Other: Swallowing education	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A randomized controlled trial
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Comprehensive Swallowing Rehabilitation in Patients With Multiple System Atrophy: A Randomized Controlled Trial
• Actual Study Start Date: May 17, 2021
• Estimated Primary Completion Date: May 30, 2024
• Estimated Study Completion Date: June 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Comprehensive swallowing rehabilitation	Other: Comprehensive swallowing rehabilitation; The treatment time per session is 30 minutes. Total 12 sessions are provided for 6 weeks.
Active Comparator: Swallowing education	Other: Swallowing education; The education is 30 minutes. Total 1 session is provided immediately after baseline evaluation.

Outcome Measures

Primary Outcome Measures :

1. Penetration-Aspiration Scale [ Time Frame: at 6 weeks ]
2. Videofluoroscopic dysphagia scale [ Time Frame: at 6 weeks ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Han Gil Seo, MD, PhD; 82-2-2072-1659; hgseo80@gmail.com

Locations

Korea, Republic of

Seoul National University Hospital; Recruiting

Seoul, Korea, Republic of, 03080

Contact: Han Gil Seo, MD, PhD 82-2-2072-1659 hgseo80@gmail.com

Sponsors and Collaborators

Seoul National University Hospital

Investigators

• Principal Investigator: Han Gil Seo, MD, PhD; Seoul National University Hospital

More Information

• Responsible Party: Han Gil Seo, Associate Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT04782284
• Other Study ID Numbers: MSA-swrehab-RCT
• First Posted: March 4, 2021
• Last Update Posted: October 26, 2022
• Last Verified: October 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Han Gil Seo, Seoul National University Hospital:

Multiple System Atrophy; Dysphagia; Swallowing rehabilitation; Videofluoroscopic Swallowing Study

Additional relevant MeSH terms:

Multiple System Atrophy; Shy-Drager Syndrome; Atrophy; Pathological Conditions, Anatomical; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases