EIM Testing for Neuromuscular Disorders

Recruiting at 1 trial location

Overseen By Candida 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?

Background: - Electrical impedance myography (EIM) is a new technique being studied to see if it is helpful in evaluating muscle disorders and nerve disorders. EIM looks at how a mild, painless electrical current travels through muscles. Researchers want to gain experience in using the EIM device. They will collect information on the results of using it on people with and without nerve and muscle diseases, and compare that with information from other standard tests. First, they will test the device on healthy people. Then they will test people with a variety of neuromuscular diseases. Because the test is noninvasive and not painful, researchers will test both children and adults. Objectives: - To gain experience using the EIM muscle testing device. Eligibility: * Healthy volunteers at least 2 years old. * Individuals at least 2 years old who have neuromuscular disease. Design: * Participants will be screened with a medical history and physical exam. * Participants will have one 2-3 hour clinic visit. Researchers may request follow-up visits. * Participants will be tested with the EIM device. The device and small electrodes will be placed on their skin. An electric current will pass through the device, but the participants will not feel this. * Participants may have an ultrasound test. A gel will be put on their skin, and a device will be moved over the skin. * Participants may have a nerve test. Electrodes will be placed on their skin, and they will feel a small shock. * Participants may have a test where a thin needle is inserted in their muscle.

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.

Is Electrical Impedance Myography (EIM) safe for humans?

Electrical Impedance Myography (EIM) is generally considered safe for humans as it is a non-invasive technique that uses a weak, high-frequency electrical current to assess muscle conditions. Studies have been conducted on both healthy volunteers and patients with neuromuscular disorders, supporting its safety and utility. ^{1 2 3 4 5}

How is the treatment Electrical Impedance Myography (EIM) different from other treatments for neuromuscular disorders?

Electrical Impedance Myography (EIM) is unique because it is a non-invasive technique that uses a weak, high-frequency electrical current to assess muscle health and detect changes in muscle composition. Unlike other treatments, EIM can be used as a diagnostic tool and a biomarker for monitoring disease progression and treatment effectiveness without requiring extensive patient cooperation or evaluator training. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Electrical Impedance Myography (EIM) for neuromuscular disorders?

Research shows that Electrical Impedance Myography (EIM) can help diagnose and monitor neuromuscular disorders by measuring changes in muscle health. It has been effective in tracking disease progression and assessing treatment benefits in conditions like muscular dystrophy and amyotrophic lateral sclerosis. ^{1 2 4 6 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 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 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) 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]

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) 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]

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]

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) 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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Electrical Impedance Methods in Neuromuscular Assessment: An Overview. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Electrical Impedance Myography and Its Applications in Neuromuscular Disorders. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Electrical impedance myography: A critical review and outlook. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Electrical impedance myography in the bedside assessment of inflammatory myopathy. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Optimizing electrical impedance myography measurements by using a multifrequency ratio: a study in Duchenne muscular dystrophy. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Electrical impedance myography in healthy volunteers. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Test-retest reproducibility of 50 kHz linear-electrical impedance myography. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Electrical impedance myography in the detection of radiculopathy. [2015]