Muscle Health Measurements Using Electrical Impedance Myography

March 30, 2026 updated by: Pushpa Narayanaswami, Beth Israel Deaconess Medical Center

Convenient Quantification of Myopathic Change in Muscle Via Electrical Impedance Myography

This study is being done to further develop a device, the mScan, to measure muscle health as compared to measurements of muscle health using MRI (magnetic resonance imaging). This device is held against the skin and uses Electrical Impedance Myography (EIM). EIM uses a very small, noninvasive (e.g. no needles), brief (about 6 seconds), and painless electrical current to measure the muscle. The investigators will look at how the mScan predicts the muscle measurements seen on MRI in people with and without muscle disease. The investigators hope that this can be used in the future as a quick, convenient and less time-consuming way than MRI to assess muscle health. This could be used to measure how well treatments for different muscle disorders are working over a period of time.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Magnetic resonance imaging (MRI) is an important clinical tool for tracking skeletal muscle disease and response to therapy in a variety of conditions ranging from muscular dystrophy to myositis. MRI can serve as a surrogate measure of skeletal muscle pathology; it can quantify atrophy, edema, fatty infiltration, and myofiber disorganization, obviating the need for biopsy. There is little question that tracking MRI changes will speed therapeutic clinical trials in many muscle diseases; its use has been strongly encouraged. Although MRI can provide excellent assessment of muscle condition, MRI has many drawbacks including high cost, general inconvenience, need for the subject to lie flat without moving, limited evaluation of upper extremity muscles, need for detailed image analysis to distill complex imaging data down to a simple value for disease tracking, difficulty obtaining repeated measurements in a clinical trial, and challenges in standardization of protocols across institutions. These limitations prevent MRI from being an easily applied biomarker for assessment of muscle health and disease status. A technology that offers compositional information similar to MRI but that overcomes MRI's many drawbacks could serve as an extraordinary powerful biomarker in regular patient care and clinical therapeutic trials.

Electrical impedance myography (EIM) is such a technology. In fact, EIM is currently being used as biomarker in a number of neuromuscular disorders. In EIM, using a small handheld device, a weak, directionally focused, multi-frequency electrical current is applied to a muscle, resulting surface voltages are measured, and impedance values are derived. Alterations in these values provide insight into the condition of muscle, including atrophy, edema, fatty infiltration, and myofiber disorganization. In addition to ALS, EIM has already shown considerable value as a biomarker in a number of disorders including muscular dystrophy, myositis, and simple deconditioning. In sum, the investigators hypothesize that EIM has the potential to serve as a proxy for MRI, providing much of the same information but with far greater speed and convenience, lower cost, smaller size, greater flexibility and tolerability and without the need for cumbersome image analysis.

While much data has been acquired showing EIM is sensitive to muscle health, there is only sparse data relating EIM directly to MRI. Given the complexity of both EIM and MRI, applying machine learning approaches to these data sets can serve as a means for establishing a relationship between these two technologies. This would allow EIM to serve as an extremely convenient tool for tracking muscle health and potentially as a biomarker in future clinical therapeutic trials and day-to-day patient care.

Research Question: Can EIM supplement and potentially substitute for MRI in the assessment of primary diseases of skeletal muscle (myopathies)?

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
        • Principal Investigator:
          • Pushpa Narayanaswami, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients Diagnosed with Myopathies and Healthy Controls

Description

Inclusion Criteria:

  • Ages 18-89
  • Evidence of a primary myopathic condition as determined by detailed chart review, including results of genetic testing, serological data, or previous muscle biopsy

Exclusion Criteria:

  • Inability to lie flat or history of claustrophobia
  • >1+ lower extremity edema
  • Presence of multiple other pathologies affecting lower extremity muscles to be studied
  • Pregnancy
  • Contraindications for MRI scanning - e.g. MRI incompatible pacemaker, deep brain stimulator, or lower extremity hardware

  • Contraindications to undergo DXA Scan

    • Any studies/scans with a radioisotope within the past 15 days
    • Any imaging with radiographic contrast in the past 7 days
    • Weight greater than 450 lbs
    • Calcium supplements or antacids containing calcium in the past 24 hours
  • Severe obesity with BMI > 35 kg/m2, given difficulties fitting in MRI scanner and impact of severe obesity on EIM data
  • Chronic skin conditions with ulcerations which would interfere with EIM electrode contact or be uncomfortable for the participant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Control
Device: Electrical Impedance Myography
EIM is an impedance-based technology in which an imperceptible, high-, multi-frequency (e.g., 1 kHz to 10 MHz) electrical current is applied across two electrodes; the resulting voltage signals are measured across two sense electrodes
Myopathy
Participants with Myopathies
Device: Electrical Impedance Myography
EIM is an impedance-based technology in which an imperceptible, high-, multi-frequency (e.g., 1 kHz to 10 MHz) electrical current is applied across two electrodes; the resulting voltage signals are measured across two sense electrodes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathology-specific penalized regression development. Predictive algorithms connecting EIM data sets to MRI outcomes representative of muscle pathology, including muscle cross-sectional area, fat content, edema, and fiber disorganization.
Time Frame: Two years

A. EIM data preparation: Outputs including resistance, reactance, and phase values at 41 frequencies between 10 kHz to 10 MHz in both longitudinal and transverse directions, will be used. Raw EIM data will be filtered using an automated algorithm that deletes statistically defined errant individual frequency points.

B. MRI analysis of data after preparation C. Penalized regression approach-basic approach using least absolute shrinkage and selection operator (Lasso)21 for assessing the entire multifrequency set up to 10 MHz will be used to develop predictive models of EIM with further nested cross validation. D: This trained model will then be applied specifically to the remaining 20% of data which will serve as the test set and final values in RMSE will then be calculated for this second data set. The investigators will define success as achieving an R value 0.6 or greater, which is considered a moderate-to-strong association for most clinical outcomes
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Myolex, Inc

Investigators

  • Principal Investigator: Pushpa Narayanaswami, M.D., Beth Israel Deaconess Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24P000762
  • 1R44AR083316-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data which is not considered proprietary per SBIR allowances will be shared publicly through existing websites (such as the Dryad database). Investigators will include relevant clinical and demographic information (all deidentified). The Digital Object Identifier (DOI) will be referenced in any publication to allow the research community easy access to the exact data used in the publication. The results of the study will also be shared via publication and at national and international scientific meetings in the neurology and engineering fields as well as in conferences focused on primary neuromuscular diseases.

IPD Sharing Time Frame

Upon completion and primary analysis of the study

IPD Sharing Access Criteria

Public

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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