Muscle Health Measurements Using Electrical Impedance Myography (NCT07502989) | Clinical Trial Compass
RecruitingNot Applicable
Muscle Health Measurements Using Electrical Impedance Myography
United States150 participantsStarted 2025-04-09
Plain-language 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.
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.