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NCT06153108 Clinical Trial

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

Inclusion Body Myositis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06153108
Other study ID # Biosensics IBM
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 16, 2023
Est. completion date December 2024

Study information
Verified date November 2023
Source University of Kansas Medical Center
Contact Samantha Colgan
Phone 913-945-9938
Email scolgan@kumc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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, we 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers
Gender All
Age group 45 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• PAMSys pendant PAMSys wrist sensors
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

Locations
Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (2)
Lead Sponsor Collaborator
University of Kansas Medical Center BioSensics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 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. Baseline, Month 6, Month 12
See also
  Status Clinical Trial Phase
Completed NCT00769860 - Arimoclomol in Sporadic Inclusion Body Myositis Phase 2/Phase 3
Completed NCT01165008 - Anakinra in Myositis Phase 2/Phase 3
Recruiting NCT05890833 - The Risk of Falls Index for Patients With Neuromuscular Disorders
Active, not recruiting NCT05046821 - Sporadic Inclusion Body Myositis Natural History Study
Active, not recruiting NCT04659031 - A Phase 1 Study of ABC008 in Ascending (Single Ascending Dose/Multiple Ascending Dose) Study in Patients With (IBM) Phase 1
Completed NCT03440034 - Study of Pioglitazone in Sporadic Inclusion Body Myositis Phase 1
Terminated NCT04049097 - Arimoclomol in Sporadic Inclusion Body Myositis - Open Label Extension Trial Phase 3
Completed NCT00001261 - Intravenousimmunoglobulin (IVIg) for the Treatment of Inflammatory Myopathies Phase 2
Recruiting NCT05272969 - Pompe & Pain - Study to Assess Nociceptive Pain in Adult Patients With Pompe Disease
Completed NCT01734369 - Environmental Risk Factors for Myositis in Military Personnel
Active, not recruiting NCT04975841 - Inclusion Body Myositis Treatment With Celution Processed Adipose Derived Regenerative Cells N/A
Recruiting NCT00017914 - Adult and Juvenile Myositis
Completed NCT00917956 - Lithium in Inclusion Body Myositis (IBM) N/A
Completed NCT03633318 - Establishing Muscle Impedance Parameters With Electrical Impedance Myography
Recruiting NCT04789070 - Phase III Trial of Sirolimus in IBM Phase 3
Active, not recruiting NCT05721573 - A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis Phase 2/Phase 3
Recruiting NCT05032131 - Cell Therapy for IBM by Muscle Injection of ADSVF Phase 1
Completed NCT03299335 - Molecular Profile of the Evolution of Inclusion Body Myositis N/A
Completed NCT04421677 - Safety and Tolerability of Phenylbutyrate in Inclusion Body Myositis Phase 1
Completed NCT02753530 - Study of Arimoclomol in Inclusion Body Myositis (IBM) Phase 2