An observational study in Myopathy, Muscular Dystrophies and Myositis, sponsored by Beth Israel Deaconess Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by Beth Israel Deaconess Medical Center · Observational
Among 99 studies in Muscular Diseases with a site in United States — 21 open to participants now, 29 under way, 5 of them phase 3. Muscular Diseases · United States.
Among the 99 studies in Muscular Diseases with a site in United States, this one is the 11th largest by planned enrollment of the 30 observational ones, is one of 6 that started in 2025, is one of 31 observational ones, reaches primary completion later than 7 of the 25 other live ones, and was the 96th registered.
232 studies on the registry are indexed under Muscular Diseases; 54 are open to participants now.
This study's planned enrollment of 150 is above the median of 95 across 85 observational studies indexed under Muscular Diseases.
Browse Muscular Diseases studies →21 of the 99 studies in Muscular Diseases with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 38 Muscular Diseases studies recruiting now, 21 (55%) set no upper age limit and 10 (26%) stop at 75 or younger; 15 take children under 18; 8 take healthy volunteers.
This study: 18 Years to 89 Years · all sexes · healthy volunteers too.
The full table on the hub →99 studies; the count open now beside each. This study's row is marked.
First in 1984; this study’s year is marked. 6 started in 2025.
Median enrollment 38 across the 66 interventional studies, 70 across the 30 observational. Of the 63 that completed or were terminated, 31 (49%) have results posted.
40 of 99 have an industry lead sponsor. The 10 most frequent:
Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 80 are open to participants now.
Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.
Beth Israel Deaconess Medical Center has 4 studies filed under Muscular Diseases — fewer than ten, so there is no comparison to draw.
8 of the studies in Muscular Diseases with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06599697University of Alabama at BirminghamThe MIGHT Trial - An Exploratory Clinical Trial of IVIG in Anti-HMGCR Immune Mediated Necrotizing Myopathy | 2026-12-30 |
| NCT06374719Clinic for Special ChildrenWiTNNess - TNNT1 Myopathy Natural History Study | 2027-01-01 |
| NCT06185764Vertex Pharmaceuticals IncorporatedA Phase 1/2 Study of VX-670 in Adult Participants With Myotonic Dystrophy 1 (DM1) | 2027-02-02 |
| NCT06916806AstraZenecaA Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis. | 2027-05-05 |
| NCT02842424University of NebraskaRamipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis | 2027-06 |
Among the 99 studies in Muscular Diseases with a site in United States, from their registry updates:
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.
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)?
Patients Diagnosed with Myopathies and Healthy Controls
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Contraindications to undergo DXA Scan
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Electrical Impedance Myography
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
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.
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
Time frame: Two years
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Upon completion and primary analysis of the study
Access criteria: Public
Started Apr 2025 (actual). Primary completion is estimated for Jun 2027, 25 months after the start.
Of 36 observational studies under Muscular Diseases, half reached primary completion within 75 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 159. This study's planned 25 months is below that.
How these figures are worked out, and which studies are left out of them.
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No contact was published for this record. The registry link below has the sponsor’s details.
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Beth Israel Deaconess Medical Center →