Neuromuscular DiseaseNCT01900132
Electrical Impedance Myography: Natural History Studies inNeuromuscular Disorders and Healthy Volunteers
A study testing EIM testing, Nerve & muscle ultrasonography and Nerve conduction studies in people with Neuromuscular Disease and Motor Neuron Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Disease, Motor Neuron Disease, Inherited Neuromuscular Conditions
- What is being tested?
- EIM testing, Nerve & muscle ultrasonography and Nerve conduction studies
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2013to 1 Jun 2027
- Phase
- Interventional
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 2 to 110 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- HEALTHY VOLUNTEERS-ADULTS
- Healthy adults, male or female, aged 18 years old or older,
- In good general health as evidenced by medical history
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- HEALTHY VOLUNTEERS-PEDIATRIC
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- Healthy children, male or female, age 7-18,
- In good general health as evidenced by medical history
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Ability of subject or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.
- SUBJECTS WITH NEUROMUSCULAR DISEASE
- Adult and pediatric, male or female, patients with a neuromuscular disorder are eligible even if the exact etiology of the disorder is unknown at the time of enrollment into this study. This will include neuropathy, myopathy and motor neuron disorders. It is expected that the subjects are undergoing appropriate standard diagnostic and genetic work-up outside of this protocol that will later clarify the specific etiology of the disorder. Movement disorders will also be included because of the prior research done on dystonia and EIM.
- Suspected motor neuron disease or
- Suspected myopathy or
- Suspected neuropathy or
- Suspected movement disorders that impair intracortical processes
- Age of 2 years or older
- Ability of subject to sign a written informed consent document.
- NIH EMPLOYEES:
- NIH employees and staff may participate, however EMG Section, OCD, NINDS, employees may not participate.
Who cannot join
- HEALTHY VOLUNTEERS-ADULTS
- Medical conditions that require medications that affects the physiological measures being tested. Some conditions that may be excluded are diabetes, kidney and liver disease.
- History of stroke, muscle disorders, peripheral neuropathy or spine surgery
- HEALTHY VOLUNTEERS-PEDIATRIC
- Medical conditions that require medications that affects the physiological measures being tested. Some conditions that may be excluded are diabetes, kidney and liver disease.
- History of stroke, muscle disorders, peripheral neuropathy or spine surgery
- SUBJECTS WITH NEUROMUSCULAR DISEASE:
- No clinical evidence of a neuromuscular disorder on clinical evaluation.
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
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Electrical Impedance Myography: Natural History Studies in Neuromuscular Disorders and Healthy Volunteers
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.
Read more
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.
Read the detailed description
Study Description: This is a natural history study examining the utility of electrical impedance myography (EIM) device in the evaluation of neuromuscular disorders. This is a novel device so the initial step was to establish reproducibility of the data and expected normative values using the EIM device on healthy volunteers. In neuromuscular disorders, the EIM device will be used to understand the results in different types of neuromuscular disorders. A subset of subjects with neuromuscular disorders are studied serially as preliminary evaluation of its utility as a biomarker in clinical studies. The protocol includes both adult and pediatric subjects.
Objectives:
Primary objective: For subjects with neuromuscular disease, we aim to understand if EIM has utility in differentiating neuromuscular disorders in adult and pediatric subjects. Also, to perform preliminary serial studies to understand the EIM device potential use as biomarker in clinical studies.
For healthy volunteers, the primary objective is reproducibility of results and the range of normative values in adult and pediatric subjects.
Secondary objectives: The three parameters, phase, reactance, resistance will be followed serially as measures of change in pediatric population.
As exploratory outcome measures, we will explore correlations between EIM and ultrasound and other electrodiagnostic methods.
Endpoints:
Primary endpoint:
For healthy volunteers, intra and interrater reliability will be evaluated to determine the utility of EIM as a reproducible biomarker. Normative values will be developed using a range of ages, mixed gender, and race to be used as a basis of comparison with subjects with neuromuscular disorders.
For subjects with neuromuscular disorders, patterns of phase, resistance and reactance in different types of neuromuscular disorders will be evaluated and examined for patterns specific to type of neuromuscular disorder.
Secondary endpoint:
The three parameters, phase, reactance, resistance will be followed serially as measures of change. This will be evaluated in small groups of neuromuscular disorders that are referred to this protocol. A cohort of pediatric healthy volunteers will be followed for two years for comparative data with pediatric subjects with neuromuscular disorders.
Exploratory endpoint:
The EIM phase, muscle ultrasound and possibly MUNIX will be compared in healthy volunteers.
- Conditions
- Neuromuscular Disease, Motor Neuron Disease, Inherited Neuromuscular Conditions, Inherited Neuropathies
- Being tested
- EIM testing, Nerve & muscle ultrasonography, Nerve conduction studies, Electromyography (EMG)
- Keywords
- Electrophysiology, Neuromuscular Disease
- Medical subject headings
- Neuromuscular Diseases, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIM testingDevice
EIM device is placed on the muscle and a high frequency current is delivered to the skin.
Nerve & muscle ultrasonographyDevice
Ultrasound waves to examine the muscles and nerves
Nerve conduction studiesDevice
Small metal disk electrodes attached to wires onto skin to measure how fast nerves conduct electrical impulses and the strength of the connection between nerves and muscles.
Electromyography (EMG)Device
Thin needle placed into muscles to record electrical activity-adults only
| Study group | Role | What they receive |
|---|---|---|
| 1/All Subjects | Experimental | Healthy Volunteers and patients Receives: Device: EIM testing; Device: Nerve & muscle ultrasonography; Device: Nerve conduction studies; Device: Electromyography (EMG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients - EIM measures for a selection of muscles
Obtaining measures using EIM device in different types of neuromuscular disorders.
Measured: End of study
Healthy Volunteers - EIM measures for a selection of muscles with the aim of developing normative values for the NIH EMG lab
Obtaining measures using EIM device- reproducibility and normative data
Measured: End of study
Secondary outcomes (2)
Serial studies in pediatric patients
Serial measures of EIM in patients with neuromuscular disorders
Measured: End of study
Healthy Volunteers - exploratory correlations of ultrasound and electrodiagnostic methods such nerve conduction studies and less likely, EMG
Obtaining measures using EIM device and comparing with ultrasound and motor unit number estimation techniques.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study start20 Jun 2013
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Tanya J Lehky, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900132
- Sponsor's protocol ID
- 130165
- Other IDs
- 13-N-0165
- Status last verified
- 21 Sep 2026
- First submitted
- 11 Jul 2013
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is no formalized plan to make IPD available of a website. The data from this protocol would be available in anonomyzed format in relationship to publications.
Publications
Nichols C, Jain MS, Meilleur KG, Wu T, Collins J, Waite MR, Dastgir J, Salman A, Donkervoort S, Duong T, Keller K, Leach ME, Lott DJ, McGuire MN, Nelson L, Rutkowski A, Vuillerot C, Bonnemann CG, Lehky TJ. Electrical impedance myography in individuals with collagen 6 and laminin alpha-2 congenital muscular dystrophy: a cross-sectional and 2-year analysis. Muscle Nerve. 2018 Jan;57(1):54-60. doi: 10.1002/mus.25629. Epub 2017 Apr 25.
PubMed 28224647Schwartz DP, Dastgir J, Salman A, Lear B, Bonnemann CG, Lehky TJ. Electrical impedance myography discriminates congenital muscular dystrophy from controls. Muscle Nerve. 2016 Mar;53(3):402-6. doi: 10.1002/mus.24770. Epub 2015 Aug 13.
PubMed 26179210Offit MB, Wu T, Floeter MK, Lehky TJ. Electrical impedance myography (EIM) in a natural history study of C9ORF72 mutation carriers. Amyotroph Lateral Scler Frontotemporal Degener. 2020 Aug;21(5-6):445-451. doi: 10.1080/21678421.2020.1752247. Epub 2020 Apr 21.
PubMed 32312103