Comprehensive Swallowing Rehabilitation in Patients With MSA

Multiple System Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04782284
• Other study ID #: MSA-swrehab-RCT
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: Han Gil Seo, MD, PhD
• Phone: 82-2-2072-1659
• Email: hgseo80[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Multiple System Atrophy
• Shy-Drager Syndrome

Intervention

Other:
• Comprehensive swallowing rehabilitation
The treatment time per session is 30 minutes. Total 12 sessions are provided for 6 weeks.
• Swallowing education
The education is 30 minutes. Total 1 session is provided immediately after baseline evaluation.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Penetration-Aspiration Scale		at 6 weeks
Primary	Videofluoroscopic dysphagia scale		at 6 weeks
Secondary	Penetration-Aspiration Scale		at 12 weeks
Secondary	Videofluoroscopic dysphagia scale		at 12 weeks
Secondary	Peak Cough Flow		at 6 weeks, at 12 weeks
Secondary	Maximal Inspiratory Pressure		at 6 weeks, at 12 weeks
Secondary	Maximal Expiratory Pressure		at 6 weeks, at 12 weeks
Secondary	Forced vital capacity		at 6 weeks, at 12 weeks
Secondary	Forced expiratory volume		at 6 weeks, at 12 weeks
Secondary	Maximal phonation time		at 6 weeks, at 12 weeks
Secondary	Swallowing disturbance questionnaire		at 6 weeks, at 12 weeks
Secondary	Swallowing Quality of Life questionnaire		at 6 weeks, at 12 weeks