Monitoring Biomarker for Detecting Change in Physical Activity and Limb Function in Inclusion Body Myositis Over Time

NCT06153108 — Active not recruiting, 20 participants, University of Kansas Medical Center

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Registry	NCT06153108
Status	Active not recruiting
Study type	Observational
Enrollment	20 (Estimated)
Sponsor	University of Kansas Medical Center (Other); collaborators: BioSensics
Conditions	Inclusion Body Myositis
Interventions	PAMSys pendant PAMSys wrist sensors (Device)
Dates	start 2023-11-16, primary completion 2028-02-01 (estimated), completion 2028-02-01 (estimated), first posted 2023-12-01, last updated 2026-06-29
Locations	1 site in United States

-Summary

Inclusion-Body Myositis (IBM) results in weakness and the deterioration of distal arm muscles, the symptoms of which are currently assessed through expert examination at clinical visits. Such in-clinic assessments are time-consuming, subjective, of limited sensitivity, and only provide a snapshot of a patient's disease. In this project, the investigators will conduct clinical validation of monitoring digital biomarkers of upper limb function during activities of daily living using a wearable sensor platform that enables frequent, at-home monitoring of upper limb function health in IBM and could be incorporated into IBM trials.

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+Arms and interventions

PAMSys pendant PAMSys wrist sensors (Device): The PAMSysTM sensor consists of a 3-axis accelerometer, battery, and built-in memory for recording long-term data. Accelerometer data is recorded at a sampling frequency of 50 Hz

+Outcome measures

Primary outcomes

Investigate validity of PAMSys wrist sensor and pendant sensor as monitoring biomarker of upper and lower limb function and physical activity, including leg function, change in IBM patients. [Baseline, Month 6, Month 12]: will investigate if sensor-derived parameters measured by the PAMSys wrist sensors and pendant sensor can quantify disease severity and track subtle changes in upper and lower limb health and ambulation over time.

+Eligibility

Sex: All, ages: 45 Years to any

Inclusion Criteria:

1. Meet any of the European Neuromuscular Centre Inclusion Body Myositis research diagnostic criteria 2011 categories for IBM.
2. Able to provide informed consent.

Exclusion Criteria:

1. Unwillingness to follow study procedures.
2. Participation in an investigational drug research study within the past 30 days.

+Locations (1)

Facility	City	Country	Status
University of Kansas Medical Center	Kansas City, Kansas	United States

+Investigators

Mazen Dimachkie, MD, Principal investigator, University of Kansas Medical Center