Recruiting

mScan

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT07502989

Conditions

Myopathy

Muscular Dystrophies

Myositis

Myofibrillar Myopathy

Congenital Myopathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Electrical Impedance Myography

Study Details

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. 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.

Conditions

Myopathy

Muscular Dystrophies

Myositis

Myofibrillar Myopathy

Congenital Myopathy

Study ID

NCT07502989

Start date

Apr 9, 2025

Status verified date

Feb, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Control

Myopathy

Participants with Myopathies

Interventions

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Amy Lewandowski

617-667-2545alewand2@bidmc.harvard.edu

Principal Investigator:

Pushpa Narayanaswami, M.D.

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Apr 3, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-04-03.