Clinical trial NCT03633318: Establishing Muscle Impedance Parameters With Electrical Impedance Myography
Official title: Application of Electrical Impedance Myography (EIM) to Establish Muscle Impedance Parameters as a Potential Biomarker of Inclusion Body Myositis (IBM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IBM
Inclusion Body Myositis
Keywords: electrical impedance myography
EIM
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 31
Sex: ALL
Minimum age (years): 46
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with IBM compared with age and sex matched people of typical health with: no active neuromuscular disorders or known history of neuromuscular disorders; no sign or symptoms of muscle weakness; no family history of muscular dystrophies or ALS.

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Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: IBM-Functional Rating Scale
timeFrame: 45 Minutes
measure: Grip Strength
timeFrame: 45 Minutes
measure: Time to Stand
timeFrame: 45 Minutes
measure: Walking Distance
timeFrame: 45 Minutes
measure: Manual Muscle Testing (MMT) Global Score
timeFrame: 45 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Physicians Building
state: Connecticut
Study officials:
affiliation: Yale School of Medicine: Department of Neurology
name: Bhaskar Roy, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale School of Medicine: Department of Neurology
name: Richard J Nowak, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: