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Establishing Muscle Impedance Parameters With Electrical Impedance Myography

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Yale University

Status

Completed

Conditions

Inclusion Body Myositis
IBM

Treatments

Device: electrical impedance myography (EIM)

Study type

Observational

Funder types

Other

Identifiers

NCT03633318
2000023035

Details and patient eligibility

About

The primary aim of this study is to assess the changes in the impedance parameters of muscles in inclusion body myositis (IBM) through electrical impedance myography (EIM), an emerging non-invasive electrodiagnostic technology. Muscle impedance parameters can potentially serve as an objective biomarker reflecting disease progression and severity.

Full description

In this pilot study, the electrical impedance myography (EIM) parameters of individuals with inclusion body myositis (IBM) will be compared with age and sex matched normal data. Along with EIM parameters, clinical outcome measures will be obtained to understand how EIM data correlates with these parameters. A focused study to assess muscle health in IBM patients through EIM is essential to gather further insight into the potential application of this technology as a disease biomarker. Additionally, this investigation will provide critical data for the design of a subsequent biomarker validation study.

Enrollment

31 patients

Sex

All

Ages

46+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Clinico-pathologically defined IBM in the absence of any other significant neurological problem or cognitive dysfunction.
  • Healthy controls will be age and gender-matched to the enrolled IBM patients.

Exclusion Criteria for both IBM and control group:

  • Patients with decompensated congestive heart failure
  • Patients with chronic kidney disease on hemodialysis
  • Patients with active cancer on chemotherapy or radiotherapy
  • Patients with severe disease who are already wheel-chair bound

Trial design

31 participants in 2 patient groups

IBM Group
Description:
Participants in this arm will have Inclusion Body Myositis (IBM). All patients will have EIM measurements of selected muscles.
Treatment:
Device: electrical impedance myography (EIM)
Control Group
Description:
Participants in this arm will be healthy controls. All participants will have EIM measurements of selected muscles.
Treatment:
Device: electrical impedance myography (EIM)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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