Muscle Health Measurements Using Electrical Impedance Myography

NCT07502989 | Recruiting

• 2 other identifiers: 24P0007621R44AR083316-01A1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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. We will be looking at how the mScan predicts the muscle measurements seen on MRI in people with and without muscle disease. We 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.

Conditions

Myopathy; Muscular Dystrophies; Myositis; Myofibrillar Myopathy; Congenital Myopathy; Distal Myopathy; Myopathies

Keywords

Muscle Health; Myopathy; Device; Healthy control; MRI; Electrical Impedance Myography; EIM

Outcome Measures

Primary Outcomes (1)

• Pathology-specific penalized regression development. We will develop predictive algorithms connecting EIM data sets to MRI outcomes representative of muscle pathology, including muscle cross-sectional area, fat content, edema, and fiber disorganization,

  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. We 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

Study Arms (2)

Healthy Control

Device: Electrical Impedance Myography

Myopathy

Participants with Myopathies

Device: Electrical Impedance Myography

Interventions

Electrical Impedance Myography DEVICE

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

Healthy Control; Myopathy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients Diagnosed with Myopathies and Healthy Controls

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• Myolex, Inc: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (29)

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Related Links

• Pre-Screening Survey
• Myolex EIM Information

MeSH Terms

Conditions

Muscular Diseases; Muscular Dystrophies; Myositis; Myofibrillar Myopathy; Myotonia Congenita; Distal Myopathies

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Muscular Disorders, Atrophic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Myotonic Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases

Study Officials

• Pushpa Narayanaswami, M.D.

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Chair of Clinical Operations; Professor of Neurology

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start: April 9, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon completion and primary analysis of the study
• Access Criteria: Public

Locations

US (1)