Multiple System Atrophy And Caregivers And What Constitutes Meaningful Change On The Umsars-I Scale

Overview

About this study

The purpose of this study is to generate qualitative insights from people with MSA (or caregivers of people with MSA) on their perspective of what constitutes meaningful change on the UMSARS–I scale across the range of disease severity (in mild, moderate, and severe Multiple System Atrophy).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria People with MSA:

  • Be an adult with a diagnosis of possible or probable Multiple Systems Atrophy (MSA) of the parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C).
  • Have an UMSARS-I score ≤32 (omitting item 11 on sexual function) or a mild to moderate overall level of motor and autonomic disability based on the judgement of the treating healthcare professional.
  • Have normal cognitive performance, as assessed by a healthcare professional.
  • Have speech unaffected or only mildly affected (i.e., no difficulties being understood).
  • Reside in the US .
  • Speak, write, and read fluently in English.
  • Be willing and able to provide informed consent or assent.
  • Be willing and able to maintain focus for one uninterrupted 60-minute telephone interview.
  • Have access to an internet-connected computer or mobile device.

Exclusion Criteria: People with MSA

  • Have evidence (clinically or on MRI) and/or history of any clinically significant disease or condition other than MSA (for example, serious neurological disorder, other intracranial disease, or systemic disease).
  • Have a current diagnosis of movement disorders that could mimic MSA (for example, Parkinson' disease, dementia with Lewy bodies, essential tremor, progressive supranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasal degeneration, or vascular, pharmacological, or post-encephalitic parkinsonism), per investigator discretion. Have qualified for, enrolled, and participated in the AMULET clinical trial beyond screening.

Caregiver Inclusion Criteria:

  • Be the caregiver of a person that has a diagnosis of possible or probable Multiple Systems Atrophy (MSA) of the parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C).
  • Be the caregiver of a person that meets at least one of the following criteria:
    • Has an UMSARS Part I score > 32 (omitting item 11 on sexual function) or severe overall level of motor and autonomic disability based on the judgement of the treating healthcare professional o Has been diagnosed with significant cognitive impairment;
    • Has speech more than mildly affected (i.e., has difficulties being understood).
  • Be an adult aged 18 or older.
  • Spend at least 2 hours per day, three days per week with the person with MSA to be able to discuss their observations of the person experience with MSA.
  • Reside in the US.
  • Speak, write, and read fluently in English.
  • Be willing and able to provide informed consent.
  • Be willing and able to maintain focus for one uninterrupted 60-minute telephone interview.
  • Have access to an internet-connected computer or mobile device.

Caregiver Exclusion Criteria:

  • Be the caregiver of a person that has evidence (clinically or on MRI) and/or history of any clinically significant disease or condition other than MSA (for example, serious neurological disorder, other intracranial disease, or systemic disease).
  • Be the caregiver of a person that has a current diagnosis of movement disorders that could mimic MSA (for example, Parkinson' disease, dementia with Lewy bodies, essential tremor, progressive supranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasal degeneration, or vascular, pharmacological, or post-encephalitic parkinsonism), per investigator discretion.
  • Have a cognitive impairment that would prevent them from completing a 60-minute telephone interview.
  • Be the caregiver of a person with MSA that has qualified for, enrolled, and participated in the AMULET clinical trial beyond screening.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/29/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Wolfgang Singer, M.D.

Closed for enrollment

Contact information:

Raelene Martini

(507) 284-0336

adc.research@mayo.edu

More information

Publications

Publications are currently not available