An Observational Study of Individuals With Isolated Dystonia

What is the Purpose of this Study?

This study focuses on people who have been diagnosed with a form of isolated (or primary) dystonia that involves one (focal) or more (segmental) areas of the body, including neck, face or limbs. Dystonia is a movement disorder that causes involuntary abnormal movements, sustained postures, or both; the condition may be painful and can affect the ability to complete daily tasks. The study will collect information to help researchers understand how dystonia impacts the patient’s life and how the condition has changed over time. The study may also help scientists to better understand clinical scales used as standard of care. Clinical scales are tools that examine how the patient is doing in various areas of life, such as the ability to control their movements, wellbeing, pain, relationships, social interactions, and progress over time. Participants will be asked to complete 2 study visits (Visit 1 and Visit 2). During Visit 1, they will be asked about their background, medical and dystonia history, and current health/medications. They will be asked to complete interview-based rating scales: the Burke-Fahn-Marsden (BFM) rating scale and Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS-2). The Clinical Global Impression-Severity (CGI-S) Rating Scale will be completed by their doctor. During Visit 2, participants will be asked about any changes to their health and dystonia symptoms and any medicines they are taking. They will also be asked to complete the same scales (BFM, TWSTRS-2); the CGI-S will be completed by their doctor.


Eligibility

  • * The participant is willing to sign an informed consent form indicating that he/she understands the purpose of the study; understands and can perform, complete, and comply with all the assessments that are required during the study; and is willing to participate in the study.
  • * The participant is a male or female between 12 and 65 years of age (inclusive).
  • * The participant has a clinical diagnosis of isolated (or primary) dystonia for at least one year prior to Visit 1 and meets the study definition of segmental/multifocal or generalized dystonia at Visit 1.
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

An Observational Study of Individuals with Isolated Dystonia

Study Details
Disease Type/Condition

Other

Principal Investigator

Tagliati, Michele

Age Group

Adult

Phase

Not Available

IRB Number

STUDY00004649

ClinicalTrials.gov ID

NCT07111663

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Tagliati, Michele

Age Group

Adult

Phase

Not Available

IRB Number

VIM0423-401

ClinicalTrials.gov ID

NCT07111663

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org