Inclusion Body MyositisNCT06153108
Monitoring Biomarker for Detecting Change in Physical Activity and Limb Function in Inclusion Body Myositis Over Time
An observational study of Inclusion Body Myositis, run by University of Kansas Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Inclusion Body Myositis
- What is being tested?
- PAMSys pendant PAMSys wrist sensors
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2023to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Adult, Older adult
Study population: Subjects with diagnosed inclusion body myositis
Who may be able to join
- Meet any of the European Neuromuscular Centre Inclusion Body Myositis research diagnostic criteria 2011 categories for IBM.
- Able to provide informed consent.
Who cannot join
- Unwillingness to follow study procedures.
- Participation in an investigational drug research study within the past 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
- Conditions
- Inclusion Body Myositis
- Being tested
- PAMSys pendant PAMSys wrist sensors
- Keywords
- Biomarker
- Medical subject headings
- Myositis, Inclusion Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAMSys pendant PAMSys wrist sensorsDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start16 Nov 2023
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inclusion Body MyositisStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- BioSensics
- Responsible party
- Sponsor
- Investigators
- Mazen Dimachkie, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153108
- Sponsor's protocol ID
- Biosensics IBM
- Status last verified
- Jun 2026
- First submitted
- 22 Nov 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Biomarker for Detecting Change in Physical Activity and Limb Function in Inclusion Body Myositis Over Time
- ClinicalTrials.gov ID
- NCT06153108
- Acronym / sponsor ID
- Biosensics IBM
- Conditions
- Inclusion Body Myositis
- Keywords
- Biomarker
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- BioSensics
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects with diagnosed inclusion body myositis
Key inclusion criteria (2 listed)
- Meet any of the European Neuromuscular Centre Inclusion Body Myositis research diagnostic criteria 2011 categories for IBM.
- Able to provide informed consent.
Key exclusion criteria (2 listed)
- Unwillingness to follow study procedures.
- Participation in an investigational drug research study within the past 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAMSys pendant PAMSys wrist sensorsThe 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 | Device | – |
Primary outcome
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.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Inclusion Body Myositis
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
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Imaging Assessment of Swallowing and Speech Muscles in Inclusion Body Myositis
IBM, Inclusion Body Myositis
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Adult and Juvenile Myositis
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Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
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The Aim of the Study is to Characterize Patients Exhibiting Muscular Atrophy and Weakness Who Require a Muscle Biopsy for Diagnosis (IBM vs Atypical MND), Through an Innovative Technique Which Enables the Evaluation of the Neuromuscular Junction Involvement in Each Condition
Inclusion Body Myositis (IBM), Motor Neuron Disease, Amyotrophic Lateral Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mazen Dimachkie, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inclusion Body Myositis, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline, Month 6, Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.