MyopathyNCT07502989
Muscle Health Measurements Using Electrical Impedance Myography
An observational study of Myopathy and Muscular Dystrophies, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopathy, Muscular Dystrophies, Myositis
- What is being tested?
- Electrical Impedance Myography
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2025to Sep 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients Diagnosed with Myopathies and Healthy Controls
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Amy Lewandowski, 617-667-2545, alewand2@bidmc.harvard.edu
Pushpa Narayanaswami, M.D.
About this study
Official title: 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.
Read the 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)?
- Conditions
- Myopathy, Muscular Dystrophies, Myositis, Myofibrillar Myopathy, Congenital Myopathy, Distal Myopathy
- Being tested
- Electrical Impedance Myography
- Keywords
- Muscle Health, Myopathy, Device, Healthy control, MRI, Electrical Impedance Myography, EIM
- Medical subject headings
- Muscular Diseases, Muscular Dystrophies, Myositis, Myofibrillar Myopathy, Myotonia Congenita, Distal Myopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Impedance MyographyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Not described Receives: Device: Electrical Impedance Myography | |
| Myopathy | Participants with Myopathies Receives: Device: Electrical Impedance Myography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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.
- 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
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start9 Apr 2025
- Primary completion1 Jun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for MyopathyStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Myolex, Inc
- Responsible party
- Principal investigator, Pushpa Narayanaswami, Beth Israel Deaconess Medical Center
- Investigators
- Pushpa Narayanaswami, M.D., Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502989
- Sponsor's protocol ID
- 24P000762
- Other IDs
- 1R44AR083316-01A1
- Status last verified
- Feb 2026
- First submitted
- 25 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Marty B, Baudin PY, Reyngoudt H, Azzabou N, Araujo EC, Carlier PG, de Sousa PL. Simultaneous muscle water T2 and fat fraction mapping using transverse relaxometry with stimulated echo compensation. NMR Biomed. 2016 Apr;29(4):431-43. doi: 10.1002/nbm.3459. Epub 2016 Jan 27.
PubMed 26814454Rutkove SB, Geisbush TR, Mijailovic A, Shklyar I, Pasternak A, Visyak N, Wu JS, Zaidman C, Darras BT. Cross-sectional evaluation of electrical impedance myography and quantitative ultrasound for the assessment of Duchenne muscular dystrophy in a clinical trial setting. Pediatr Neurol. 2014 Jul;51(1):88-92. doi: 10.1016/j.pediatrneurol.2014.02.015. Epub 2014 Feb 28.
PubMed 24814059McDonald CM, Henricson EK, Abresch RT, Florence J, Eagle M, Gappmaier E, Glanzman AM; PTC124-GD-007-DMD Study Group; Spiegel R, Barth J, Elfring G, Reha A, Peltz SW. The 6-minute walk test and other clinical endpoints in duchenne muscular dystrophy: reliability, concurrent validity, and minimal clinically important differences from a multicenter study. Muscle Nerve. 2013 Sep;48(3):357-68. doi: 10.1002/mus.23905. Epub 2013 Jul 17.
PubMed 23674289Narayanaswami P, Weiss M, Selcen D, David W, Raynor E, Carter G, Wicklund M, Barohn RJ, Ensrud E, Griggs RC, Gronseth G, Amato AA; Guideline Development Subcommittee of the American Academy of Neurology; Practice Issues Review Panel of the American Association of Neuromuscular & Electrodiagnostic Medicine. Evidence-based guideline summary: diagnosis and treatment of limb-girdle and distal dystrophies [RETIRED]: report of the guideline development subcommittee of the American Academy of Neurology and the practice issues review panel of the American Association of Neuromuscular & Electrodiagnostic Medicine. Neurology. 2014 Oct 14;83(16):1453-63. doi: 10.1212/WNL.0000000000000892.
PubMed 25313375Goemans N, Wong B, Van den Hauwe M, Signorovitch J, Sajeev G, Cox D, Landry J, Jenkins M, Dieye I, Yao Z, Hossain I, Ward SJ; Collaborative Trajectory Analysis Project (cTAP). Prognostic factors for changes in the timed 4-stair climb in patients with Duchenne muscular dystrophy, and implications for measuring drug efficacy: A multi-institutional collaboration. PLoS One. 2020 Jun 18;15(6):e0232870. doi: 10.1371/journal.pone.0232870. eCollection 2020.
PubMed 32555695Govindarajan R, Narayanaswami P. Evidence-based medicine for every day, everyone, and every therapeutic study. Muscle Nerve. 2018 Oct;58(4):486-496. doi: 10.1002/mus.26142. Epub 2018 May 18.
PubMed 29665019Pandeya SR, Nagy JA, Riveros D, Semple C, Taylor RS, Mortreux M, Sanchez B, Kapur K, Rutkove SB. Estimating myofiber cross-sectional area and connective tissue deposition with electrical impedance myography: A study in D2-mdx mice. Muscle Nerve. 2021 Jun;63(6):941-950. doi: 10.1002/mus.27240. Epub 2021 Apr 7.
PubMed 33759456Kapur K, Nagy JA, Taylor RS, Sanchez B, Rutkove SB. Estimating Myofiber Size With Electrical Impedance Myography: a Study In Amyotrophic Lateral Sclerosis MICE. Muscle Nerve. 2018 Nov;58(5):713-717. doi: 10.1002/mus.26187. Epub 2018 Sep 2.
PubMed 30175407Rutkove SB, Wu JS, Zaidman C, Kapur K, Yim S, Pasternak A, Madabusi L, Szelag H, Harrington T, Li J, Pacheck A, Darras BT. Loss of electrical anisotropy is an unrecognized feature of dystrophic muscle that may serve as a convenient index of disease status. Clin Neurophysiol. 2016 Dec;127(12):3546-3551. doi: 10.1016/j.clinph.2016.09.017. Epub 2016 Oct 13.
PubMed 27825055Garmirian LP, Chin AB, Rutkove SB. Discriminating neurogenic from myopathic disease via measurement of muscle anisotropy. Muscle Nerve. 2009 Jan;39(1):16-24. doi: 10.1002/mus.21115.
PubMed 19058193Esper GJ, Shiffman CA, Aaron R, Lee KS, Rutkove SB. Assessing neuromuscular disease with multifrequency electrical impedance myography. Muscle Nerve. 2006 Nov;34(5):595-602. doi: 10.1002/mus.20626.
PubMed 16881067Pons C, Borotikar B, Garetier M, Burdin V, Ben Salem D, Lempereur M, Brochard S. Quantifying skeletal muscle volume and shape in humans using MRI: A systematic review of validity and reliability. PLoS One. 2018 Nov 29;13(11):e0207847. doi: 10.1371/journal.pone.0207847. eCollection 2018.
PubMed 30496308Kornegay JN, Childers MK, Bogan DJ, Bogan JR, Nghiem P, Wang J, Fan Z, Howard JF Jr, Schatzberg SJ, Dow JL, Grange RW, Styner MA, Hoffman EP, Wagner KR. The paradox of muscle hypertrophy in muscular dystrophy. Phys Med Rehabil Clin N Am. 2012 Feb;23(1):149-72, xii. doi: 10.1016/j.pmr.2011.11.014.
PubMed 22239881Stevens AM, Sullivan KM, Nelson JL. Polymyositis as a manifestation of chronic graft-versus-host disease. Rheumatology (Oxford). 2003 Jan;42(1):34-9. doi: 10.1093/rheumatology/keg025.
PubMed 12509610Hamel J, Lee P, Glenn MD, Burka T, Choi IY, Friedman SD, Shaw DWW, McCalley A, Herbelin L, Dimachkie MM, Lemmers R, van der Maarel SM, Barohn RJ, Tawil R, Statland JM. Magnetic resonance imaging correlates with electrical impedance myography in facioscapulohumeral muscular dystrophy. Muscle Nerve. 2020 May;61(5):644-649. doi: 10.1002/mus.26792. Epub 2020 Jan 22.
PubMed 31884698
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convenient Quantification of Myopathic Change in Muscle Via Electrical Impedance Myography
- ClinicalTrials.gov ID
- NCT07502989
- Acronym / sponsor ID
- 24P000762
- Conditions
- Myopathy, Muscular Dystrophies, Myositis, Myofibrillar Myopathy, Congenital Myopathy, Distal Myopathy
- Keywords
- Muscle Health, Myopathy, Device, Healthy control, MRI, Electrical Impedance Myography, EIM
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Myolex, Inc
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | Device: Electrical Impedance Myography |
| Myopathy | – | Device: Electrical Impedance MyographyParticipants with Myopathies |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients Diagnosed with Myopathies and Healthy Controls
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Impedance MyographyEIM 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 | Device | Healthy Control, Myopathy |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Background: PubMed 26814454Marty B, Baudin PY, Reyngoudt H, Azzabou N, Araujo EC, Carlier PG, de Sousa PL. Simultaneous muscle water T2 and fat fraction mapping using transverse relaxometry with stimulated echo compensation. NMR Biomed. 2016 Apr;29(4):431-43. doi: 10.1002/nbm.3459. Epub 2016 Jan 27.
- Background: PubMed 24814059Rutkove SB, Geisbush TR, Mijailovic A, Shklyar I, Pasternak A, Visyak N, Wu JS, Zaidman C, Darras BT. Cross-sectional evaluation of electrical impedance myography and quantitative ultrasound for the assessment of Duchenne muscular dystrophy in a clinical trial setting. Pediatr Neurol. 2014 Jul;51(1):88-92. doi: 10.1016/j.pediatrneurol.2014.02.015. Epub 2014 Feb 28.
- Background: PubMed 23674289McDonald CM, Henricson EK, Abresch RT, Florence J, Eagle M, Gappmaier E, Glanzman AM; PTC124-GD-007-DMD Study Group; Spiegel R, Barth J, Elfring G, Reha A, Peltz SW. The 6-minute walk test and other clinical endpoints in duchenne muscular dystrophy: reliability, concurrent validity, and minimal clinically important differences from a multicenter study. Muscle Nerve. 2013 Sep;48(3):357-68. doi: 10.1002/mus.23905. Epub 2013 Jul 17.
- Background: PubMed 25313375Narayanaswami P, Weiss M, Selcen D, David W, Raynor E, Carter G, Wicklund M, Barohn RJ, Ensrud E, Griggs RC, Gronseth G, Amato AA; Guideline Development Subcommittee of the American Academy of Neurology; Practice Issues Review Panel of the American Association of Neuromuscular & Electrodiagnostic Medicine. Evidence-based guideline summary: diagnosis and treatment of limb-girdle and distal dystrophies [RETIRED]: report of the guideline development subcommittee of the American Academy of Neurology and the practice issues review panel of the American Association of Neuromuscular & Electrodiagnostic Medicine. Neurology. 2014 Oct 14;83(16):1453-63. doi: 10.1212/WNL.0000000000000892.
- Background: PubMed 32555695Goemans N, Wong B, Van den Hauwe M, Signorovitch J, Sajeev G, Cox D, Landry J, Jenkins M, Dieye I, Yao Z, Hossain I, Ward SJ; Collaborative Trajectory Analysis Project (cTAP). Prognostic factors for changes in the timed 4-stair climb in patients with Duchenne muscular dystrophy, and implications for measuring drug efficacy: A multi-institutional collaboration. PLoS One. 2020 Jun 18;15(6):e0232870. doi: 10.1371/journal.pone.0232870. eCollection 2020.
- Background: PubMed 29665019Govindarajan R, Narayanaswami P. Evidence-based medicine for every day, everyone, and every therapeutic study. Muscle Nerve. 2018 Oct;58(4):486-496. doi: 10.1002/mus.26142. Epub 2018 May 18.
- Background: PubMed 33759456Pandeya SR, Nagy JA, Riveros D, Semple C, Taylor RS, Mortreux M, Sanchez B, Kapur K, Rutkove SB. Estimating myofiber cross-sectional area and connective tissue deposition with electrical impedance myography: A study in D2-mdx mice. Muscle Nerve. 2021 Jun;63(6):941-950. doi: 10.1002/mus.27240. Epub 2021 Apr 7.
- Background: PubMed 30175407Kapur K, Nagy JA, Taylor RS, Sanchez B, Rutkove SB. Estimating Myofiber Size With Electrical Impedance Myography: a Study In Amyotrophic Lateral Sclerosis MICE. Muscle Nerve. 2018 Nov;58(5):713-717. doi: 10.1002/mus.26187. Epub 2018 Sep 2.
- Background: PubMed 27825055Rutkove SB, Wu JS, Zaidman C, Kapur K, Yim S, Pasternak A, Madabusi L, Szelag H, Harrington T, Li J, Pacheck A, Darras BT. Loss of electrical anisotropy is an unrecognized feature of dystrophic muscle that may serve as a convenient index of disease status. Clin Neurophysiol. 2016 Dec;127(12):3546-3551. doi: 10.1016/j.clinph.2016.09.017. Epub 2016 Oct 13.
- Background: PubMed 19058193Garmirian LP, Chin AB, Rutkove SB. Discriminating neurogenic from myopathic disease via measurement of muscle anisotropy. Muscle Nerve. 2009 Jan;39(1):16-24. doi: 10.1002/mus.21115.
- Background: PubMed 16881067Esper GJ, Shiffman CA, Aaron R, Lee KS, Rutkove SB. Assessing neuromuscular disease with multifrequency electrical impedance myography. Muscle Nerve. 2006 Nov;34(5):595-602. doi: 10.1002/mus.20626.
- Background: PubMed 30496308Pons C, Borotikar B, Garetier M, Burdin V, Ben Salem D, Lempereur M, Brochard S. Quantifying skeletal muscle volume and shape in humans using MRI: A systematic review of validity and reliability. PLoS One. 2018 Nov 29;13(11):e0207847. doi: 10.1371/journal.pone.0207847. eCollection 2018.
- Pre-Screening SurveyLink provided by the sponsor.
- Myolex EIM InformationLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pushpa Narayanaswami, M.D. principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopathy and Muscular Dystrophies, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07502989, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.