Multiple System Atrophy Multidisciplinary Clinic

NCT03811808 | Recruiting

• 1 other identifier: STU 082015-008
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple System Atrophy (MSA)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Unified Multiple System Atrophy Rating Scale (UMSARS)

  at 5 year evaluation

• Caregiver Burden Index/ The Zarit Burden Interview

  at 5 year evaluation

Other Outcomes (3)

• Composite Autonomic Symptom Score (CONPASS 31)

  at 5 year evaluation

• Center for Epidemiologic Studies Depression Scale (CES-D)

  at 5 year evaluation

• The Orthostatic Hypotension Questionnaire (OHQ)

  at 5 year evaluation

Study Arms (1)

MSA patients

patients diagnosed with possible or probable multiple system atrophy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Multiple System Atrophy

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Steven Vernino, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Conger

CONTACT

214-648-0214; Amy.Conger@UTSouthwestern.edu

Steve Hopkins, CCRC

CONTACT

214-648-9275; Steve.Hopkins@UTSouthwestern.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: January 22, 2019
• Study Start: March 1, 2016
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)