EIM Testing for Neuromuscular Disorders

Recruiting at 1 trial location

Overseen By Candida C Silva

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Disqualifiers: Diabetes, Kidney disease, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

275 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called Electrical Impedance Myography (EIM), which uses a mild, painless electrical current to evaluate muscle and nerve disorders. Researchers aim to understand EIM's effectiveness by comparing it with other standard tests. The trial includes both healthy volunteers and individuals with neuromuscular disorders, such as neuropathy (nerve damage) or myopathy (muscle disease), to gain a broad understanding of the device's effectiveness. Participants must be at least 2 years old and either healthy or have a neuromuscular condition to qualify for the study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future diagnostic tools for neuromuscular conditions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are a healthy volunteer, you cannot have medical conditions that require medications affecting the physiological measures being tested.

What prior data suggests that the EIM technique is safe for evaluating neuromuscular disorders?

Research has shown that electrical impedance myography (EIM) is a safe and painless method. It uses a gentle electrical current to assess muscle and nerve health. Studies have found that people tolerate this method well because it doesn't cause discomfort. Participants in past studies did not feel the electrical current during the test. EIM has been safely used on both healthy individuals and those with muscle and nerve conditions. Overall, EIM is considered a safe and comfortable way to test muscle health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Electrical Impedance Myography (EIM) for neuromuscular disorders because it offers a non-invasive and painless way to assess muscle health. Unlike traditional methods like muscle biopsies or nerve conduction studies, which can be uncomfortable or invasive, EIM simply involves placing sensors on the skin to measure how electrical currents flow through muscles. This innovative approach could allow for more frequent monitoring of disease progression and response to treatment without the need for more invasive procedures, making it a promising tool for both patients and healthcare providers.

What evidence suggests that the EIM device is effective for evaluating neuromuscular disorders?

Studies have shown that Electrical Impedance Myography (EIM), the investigational method tested in this trial, can help assess the severity of neuromuscular diseases. EIM sends a gentle electrical current through muscles to evaluate their health. It has monitored conditions like Amyotrophic Lateral Sclerosis (ALS) and Charcot-Marie-Tooth disease, serving as a potential biomarker—a measurable sign of a biological condition—for disease progression. Research indicates that EIM is noninvasive and painless, making it suitable for both children and adults. Early findings suggest that EIM could be a valuable tool in understanding and evaluating various muscle disorders. ^{2 6 7 8 9}

Who Is on the Research Team?

Tanya J Lehky, M.D.

Principal Investigator

National Institute of Neurological Disorders and Stroke (NINDS)

Are You a Good Fit for This Trial?

This trial is for healthy individuals and those with neuromuscular diseases, aged 2 years or older. Participants must be in good health as determined by medical history, willing to follow study procedures, and able to give informed consent. Children (7-18) and adults (18+) can join; however, NIH employees involved in EMG studies cannot participate.

Inclusion Criteria

I am over 18, in good health, willing to follow the study rules, and can sign the consent form.

I have a neuromuscular disorder, possibly undiagnosed, and am over 2 years old.

Exclusion Criteria

I do not have diabetes, kidney or liver disease, history of stroke, muscle disorders, peripheral neuropathy, spine surgery, or any neuromuscular disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Initial Testing

Participants will have a 2-3 hour clinic visit for EIM testing, possibly including ultrasound and nerve tests

1 session

1 visit (in-person)

Follow-up

Participants may have follow-up visits to establish reproducibility of EIM results

As needed

Repeat visits (in-person)

Long-term Monitoring

A cohort of pediatric healthy volunteers will be followed for two years for comparative data

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Electrical Impedance Myography

Trial Overview The trial tests Electrical Impedance Myography (EIM), a technique that measures how electrical currents travel through muscles. It's compared with other standard tests like muscle ultrasonography, nerve conduction studies, and Electromyography (EMG). The goal is to evaluate its effectiveness in diagnosing various neuromuscular disorders.

How Is the Trial Designed?

Group I: 1/All Subjects Experimental Treatment 4 Interventions

Healthy Volunteers and patients

Who Is Running the Clinical Trial?

National Institute of Neurological Disorders and Stroke (NINDS)

Lead Sponsor

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

Electrical impedance myography (EIM) is a noninvasive technique that uses electrical currents to assess muscle health, showing promise as a primary diagnostic tool for neuromuscular disorders based on studies in both animals and humans.

EIM requires minimal cooperation from subjects and limited training for evaluators, making it a practical method for obtaining accurate and repeatable data in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical Impedance Myography and Its Applications in Neuromuscular Disorders. Sanchez, B., Rutkove, SB.[2020]

Electrical impedance myography (EIM) can effectively differentiate between patients with inflammatory myopathy and healthy individuals, showing a 35% lower spatially averaged phase in myositis patients.

The EIM measurements correlate significantly with muscle strength, indicating its potential as a noninvasive tool for assessing muscle function in myopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical impedance myography in the bedside assessment of inflammatory myopathy. Tarulli, A., Esper, GJ., Lee, KS., et al.[2019]

Electrical impedance myography (EIM) is a promising technology for assessing muscle health in neuromuscular diseases, showing correlations with functional, imaging, and histological data across various disorders.

This review provides essential insights for clinicians on how to interpret EIM outcomes, including its technical considerations, strengths, and limitations, which are crucial for effective application in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical impedance myography: A critical review and outlook. Sanchez, B., Martinsen, OG., Freeborn, TJ., et al.[2022]

The study assessed the reproducibility of 50 kHz linear electrical impedance myography (EIM) on three muscles (biceps, quadriceps, and tibialis anterior) in 30 normal subjects aged 21 to 90 years, showing very high reproducibility with intraclass correlation coefficients above 0.93.

With an average variability of only 4.2% across measurements, 50 kHz linear-EIM is demonstrated to be a reliable, non-invasive method for evaluating muscle health, making it suitable for both clinical assessments and research applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Test-retest reproducibility of 50 kHz linear-electrical impedance myography. Rutkove, SB., Lee, KS., Shiffman, CA., et al.[2019]

Electrical impedance myography (EIM) is a noninvasive technique that quantitatively assesses muscle condition, aiding in the diagnosis and monitoring of diseases like amyotrophic lateral sclerosis and muscular dystrophy.

EIM has shown sensitivity to disease status and may allow for clinical trials to be conducted with fewer participants, making it a promising tool for evaluating muscle health and therapy effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical Impedance Methods in Neuromuscular Assessment: An Overview. Rutkove, SB., Sanchez, B.[2021]

Electrical impedance myography (EIM) is a promising non-invasive technique that evaluates neuromuscular diseases by measuring changes in muscle composition and architecture, such as myocyte atrophy and fat deposition.

EIM can help grade the severity of neuromuscular diseases and may be useful in clinical trials and monitoring treatment effectiveness, with ongoing research aimed at refining its methods and understanding the mechanisms behind impedance changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical impedance myography: Background, current state, and future directions. Rutkove, SB.[2021]

Electrical impedance myography (EIM) effectively differentiates between normal muscle function and muscle affected by radiculopathy, showing a significant average side-to-side difference in theta(avg) of 15.3% in patients with radiculopathy compared to only 0.64% in healthy subjects.

The study suggests that EIM could be a valuable tool for assessing localized neuromuscular diseases, as greater reductions in theta(avg) were observed in muscles with more severe chronic neurogenic changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical impedance myography in the detection of radiculopathy. Rutkove, SB., Esper, GJ., Lee, KS., et al.[2015]

The study involved 28 boys with Duchenne muscular dystrophy (DMD) aged 2-13 years, using electrical impedance myography (EIM) to assess muscle function while accounting for the impact of subcutaneous fat (SF).

An optimized 50/200kHz EIM phase ratio was found to significantly reduce the correlation with SF thickness, while improving the correlation with the 6-minute walk test (6MWT), indicating that this method enhances the evaluation of neuromuscular function in DMD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing electrical impedance myography measurements by using a multifrequency ratio: a study in Duchenne muscular dystrophy. Schwartz, S., Geisbush, TR., Mijailovic, A., et al.[2021]

Electrical impedance myography (EIM) is a reliable noninvasive technique for assessing muscle properties, showing good to excellent reliability in measurements of phase, reactance, and resistance among healthy volunteers, with an intraclass correlation coefficient (ICC) of 0.920 to 0.950.

The study found no correlation between EIM measurements and muscle thickness, suggesting that EIM provides unique insights into muscle physiology that may differ from traditional ultrasound assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical impedance myography in healthy volunteers. Offit, MB., Mohammad Khanli, H., Wu, T., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01900132

Electrical Impedance Myography: Natural History Studies ... In neuromuscular disorders, the EIM device will be used to understand the results in different types of neuromuscular disorders. A subset of subjects with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2824130/

Electrical Impedance Myography: Background, Current State ... With application of single-frequency electrical current, EIM can be used to help grade the severity of neuromuscular disease. Assessing electrical impedance ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923015179

Electrical Impedance Myography and Its Applications in ... Electrical impedance myography (EIM) refers to the specific application of electrical bioimpedance techniques for the assessment of neuromuscular disorders.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02011204

Study of Electrical Impedance Myography (EIM) in ALS This trial is studying Electrical Impedance Myography (EIM) for measuring muscle health. The trial is studying people with Amyotrophic Lateral Sclerosis ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6771359/

Electrical Impedance Methods in Neuromuscular Assessment EIM is currently being used as a potential biomarker of disease progression and drug efficacy in studies of polyneuropathy, including Charcot–Marie–Tooth ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7880888/

Electrical impedance myography: a critical review and ... Electrical impedance myography (EIM) technology is finding application in neuromuscular disease research as a tool to assess muscle health.

7. nature.com nature.com/articles/s41598-025-17137-4

A two-site collaborative study of electrical impedance ... The non-invasive technique of electrical impedance myography (EIM) has shown potential as an outcome measure in patients and mouse models of ...

8. neurology.org neurology.org/doi/10.1212/WNL.0000000000208739

Electrical Impedance Myography Captures Features of ... Electrical impedance myography (EIM) has been proposed as an efficient, noninvasive biomarker of muscle composition in facioscapulohumeral muscular dystrophy ( ...

9. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2021.740877/full

Electrical Impedance Myography in Health and Physical ... Electrical impedance myography (EIM) is a non-invasive method that provides information about muscle health and changes that occur within it.