Establishing Muscle Impedance Parameters With Electrical Impedance Myography

NCT ID: NCT03633318

Last Updated: 2020-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-19

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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IBM Inclusion Body Myositis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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IBM Group

Participants in this arm will have Inclusion Body Myositis (IBM). All patients will have EIM measurements of selected muscles.

electrical impedance myography (EIM)

Intervention Type DEVICE

EIM is a measure of impedance. EIM is a measure of the obstruction of flow of current through the tissue. It is a completely painless assessment of muscle health.

Control Group

Participants in this arm will be healthy controls. All participants will have EIM measurements of selected muscles.

electrical impedance myography (EIM)

Intervention Type DEVICE

EIM is a measure of impedance. EIM is a measure of the obstruction of flow of current through the tissue. It is a completely painless assessment of muscle health.

Interventions

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electrical impedance myography (EIM)

EIM is a measure of impedance. EIM is a measure of the obstruction of flow of current through the tissue. It is a completely painless assessment of muscle health.

Intervention Type DEVICE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

46 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bhaskar Roy, MBBS

Role: PRINCIPAL_INVESTIGATOR

Yale School of Medicine: Department of Neurology

Richard J Nowak, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Yale School of Medicine: Department of Neurology

Locations

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Yale Physicians Building

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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2000023035

Identifier Type: -

Identifier Source: org_study_id

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