Multiple System Atrophy Multidisciplinary Clinic

This is a prospective cohort study to examine the disease burden of multiple system atrophy and the impact of multidisciplinary care on quality of life and caregiver burden. Data will be collected through valid rating scales completed by patients and caregivers at home or in the MSA clinic.

Study Overview

• Status: Recruiting
• Conditions: Multiple System Atrophy (MSA)

Detailed Description

Study Procedures:

Participants and caregivers will attend a multidisciplinary MSA clinic one day every four months. In addition to the standard of care, they will be asked to complete both online and paper questionnaires, including the following:

• UMSARS (Unified MSA Rating Scale)
• MSA QOL
• CES-D
• OHQ
• Compass-31
• BIC
• UPDRS
• SARA
• MDS Scale
• CGI
• MoCA

Participants will be part of the study as long as they are a patient of the MSA clinic, and will be contacted for follow-up information up to five years.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Amy Conger; Phone Number: 214-648-0214; Email: Amy.Conger@UTSouthwestern.edu
• Study Contact Backup: Name: Steve Hopkins, CCRC; Phone Number: 214-648-9275; Email: Steve.Hopkins@UTSouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern Medical Center
      • Contact: Amy Conger; Phone Number: 214-648-0214; Email: Amy.Conger@UTSouthwestern.edu
      • Contact: Steve Hopkins, CCRP; Phone Number: 214-648-9275; Email: Steve.Hopkins@UTSouthwestern.edu
      • Principal Investigator: Steven Vernino, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults 18 years or older with diagnosis of possible or probable MSA

Description

Inclusion Criteria:

• Subject must be a patient in the UT Southwestern MSA clinic and be able to attend the multidisciplinary clinic every 4 months
• Patients with possible or probable MSA based on established criteria
• Subjects must be 18 years or older

Exclusion Criteria:

• Patients that are unable to give consent
• Minor patients (younger than age 18)
• Non-English speaking patients
• Subjects that are diagnosed with dementia

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
MSA patients; patients diagnosed with possible or probable multiple system atrophy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multiple System Atrophy-Quality of Life (MSA-QoL)	The disease burden of MSA and impact of multidisciplinary care on the quality of life of patients as measured by the MSA-Quality of Life (QOL) questionnaire completed every four months by the patients. The scale measures how MSA affects a person's quality of life in day to day activities. The scale ranges from No problem to Extreme Problem. The More Extreme Problem sections selected the more their quality of life is affected by the disease.	at 5 year evaluation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unified Multiple System Atrophy Rating Scale (UMSARS)	The UMSARS completed every four months by the physician. The scale measures how MSA has progressed from baseline. The higher the score the higher the progression is.	at 5 year evaluation
Caregiver Burden Index/ The Zarit Burden Interview	The disease burden of MSA and impact of multidisciplinary care on caregiver burden as measured by the Burden Index of Caregivers (BIC) questionnaire and The Zarit Burden Interview completed every four months by the caregivers. The higher the higher the score the more burden the caregiver has.	at 5 year evaluation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Autonomic Symptom Score (CONPASS 31)	Compass 31 scale includes 31 questions and it will be used to assess autonomic symptoms that provides clinically relevant scores of autonomic symptom severity based. The higher the score the more autonomic symptoms present	at 5 year evaluation
Center for Epidemiologic Studies Depression Scale (CES-D)	The CES-D measures symptoms defined by the American Psychiatric Association' Diagnostic and Statistical Manual (DSM-V) for a major depressive episode. The higher the scores and indicative for depression present.	at 5 year evaluation
The Orthostatic Hypotension Questionnaire (OHQ)	The OHQ is used to assess the comprehensive symptom burden and severity of neurogenic orthostatic hypotension (NOH).	at 5 year evaluation

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Steven Vernino, M.D., University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (Actual): January 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Basal Ganglia Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Multiple System Atrophy
• Other Study ID Numbers: STU 082015-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO