NCT04782284

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
19mo left

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
May 2021Dec 2027

First Submitted

Initial submission to the registry

March 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 17, 2021

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

6.5 years

First QC Date

March 1, 2021

Last Update Submit

April 22, 2026

Conditions

Multiple System Atrophy

Keywords

Multiple System AtrophyDysphagiaSwallowing rehabilitationVideofluoroscopic Swallowing Study

Outcome Measures

Primary Outcomes (2)

  • Penetration-Aspiration Scale

    at 6 weeks

  • Videofluoroscopic dysphagia scale

    at 6 weeks

Secondary Outcomes (10)

  • Penetration-Aspiration Scale

    at 12 weeks

  • Videofluoroscopic dysphagia scale

    at 12 weeks

  • Peak Cough Flow

    at 6 weeks, at 12 weeks

  • Maximal Inspiratory Pressure

    at 6 weeks, at 12 weeks

  • Maximal Expiratory Pressure

    at 6 weeks, at 12 weeks

  • +5 more secondary outcomes

Study Arms (2)

Comprehensive swallowing rehabilitation

EXPERIMENTAL
Other: Comprehensive swallowing rehabilitation

Swallowing education

ACTIVE COMPARATOR
Other: Swallowing education

Interventions

Comprehensive swallowing rehabilitationOTHER

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

Comprehensive swallowing rehabilitation
Swallowing educationOTHER

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

Swallowing education

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Multiple System AtrophyDeglutition Disorders

Condition Hierarchy (Ancestors)

Primary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Han Gil Seo, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Han Gil Seo, MD, PhD

CONTACT

82-2-2072-1659hgseo80@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 4, 2021

Study Start

May 17, 2021

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations

KR(1)