Status:
UNKNOWN
Observational Study of Digital Biomarkers of Myotonia and Gait in Adults and Children With Myotonic Dystrophy
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Biogen
Conditions:
Myotonic Dystrophy 1
Eligibility:
All Genders
12-90 years
Brief Summary
The goal of this observational study is to assess movement in individuals with Myotonic Dystrophy Type 1 (DM1) and Type 2 (DM2) using digital biomarker tools. The long-term aim of this study is to inc...
Eligibility Criteria
Inclusion
- Ability to provide informed consent
- Age 12-90 years old at the time of informed consent
- Genetic confirmation of DM1 or DM2
- Ability to comply with study assessments
- Clinically apparent myotonia equivalent to hand opening time of at least 2 seconds, in the opinion of the Investigator
- Ambulatory (orthoses allowed, canes and walkers not allowed) and able to walk at least 25 meters at screening
Exclusion
- Ongoing medical condition (e.g. wasting or cachexia, severe anemia) that would, in the opinion of the Investigator, interfere with the conduct or assessments of the study
- Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, suicidal ideation, suicide attempt, or untreated major depression ≤ 90 days of screening, which in the opinion of the Investigator may interfere with the study procedures
- Treatment with an investigational drug, biologic agent, or device within one month of screening, or 5 half-lives of investigational agent, whichever is longer
- Inability to comply with study requirements
- Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the participant unsuitable for enrolment
Key Trial Info
Start Date :
September 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 10 2024
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT06089018
Start Date
September 10 2022
End Date
September 10 2024
Last Update
October 18 2023
Active Locations (1)
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1
Stanford Universtiy
Palo Alto, California, United States, 94304