Multiple System Atrophy Multidisciplinary Clinic

Multiple System Atrophy (MSA) Clinical Trial

Official title:

Multiple System Atrophy Multidisciplinary Clinic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03811808
• Other study ID #: STU 082015-008
• Status: Recruiting
• Start date: March 2016
• Est. completion date: March 2028

Study information

• Verified date: April 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Amy Conger
• Phone: 214-648-0214
• Email: Amy.Conger[@]UTSouthwestern.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Multiple System Atrophy
• Multiple System Atrophy (MSA)
• Shy-Drager Syndrome

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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