Multiple System Atrophy (MSA)NCT03811808
Multiple System Atrophy Multidisciplinary Clinic
An observational study of Multiple System Atrophy (MSA), run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple System Atrophy (MSA)
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults 18 years or older with diagnosis of possible or probable MSA
Who may be able to join
- 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
Who cannot join
- Patients that are unable to give consent
- Minor patients (younger than age 18)
- Non-English speaking patients
- Subjects that are diagnosed with dementia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Amy Conger, 214-648-0214, Amy.Conger@UTSouthwestern.edu
Steve Hopkins, CCRP, 214-648-9275, Steve.Hopkins@UTSouthwestern.edu
About this study
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.
Read the 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.
- Conditions
- Multiple System Atrophy (MSA)
- Medical subject headings
- Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MSA patients | patients diagnosed with possible or probable multiple system atrophy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 5 year evaluation
Secondary outcomes (2)
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.
Measured: 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.
Measured: at 5 year evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study startMar 2016
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System Atrophy (MSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Vernino MD PhD, University of Texas Southwestern Medical Center
- Investigators
- Steven Vernino, M.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811808
- Sponsor's protocol ID
- STU 082015-008
- Status last verified
- May 2026
- First submitted
- 5 Dec 2017
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple System Atrophy Multidisciplinary Clinic
- ClinicalTrials.gov ID
- NCT03811808
- Acronym / sponsor ID
- STU 082015-008
- Conditions
- Multiple System Atrophy (MSA)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSA patients | – | –patients diagnosed with possible or probable multiple system atrophy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults 18 years or older with diagnosis of possible or probable MSA
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Patients that are unable to give consent
- Minor patients (younger than age 18)
- Non-English speaking patients
- Subjects that are diagnosed with dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Multiple System Atrophy-Quality of Life (MSA-QoL)
Time frame: at 5 year evaluation
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.
2 secondary outcomes
Unified Multiple System Atrophy Rating Scale (UMSARS)
Time frame: at 5 year evaluation
Caregiver Burden Index/ The Zarit Burden Interview
Time frame: at 5 year evaluation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven Vernino, M.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple System Atrophy (MSA), run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Conger (214-648-0214, Amy.Conger@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple System Atrophy-Quality of Life (MSA-QoL) (time frame: at 5 year evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.