ClinicalTrials.gg
RecruitingNCT01900132Updated Oct 16, 2026

Electrical Impedance Myography: Natural History Studies inNeuromuscular Disorders and Healthy Volunteers

An interventional study of EIM testing and Nerve & muscle ultrasonography in Neuromuscular Disease, Motor Neuron Disease and Inherited Neuromuscular Conditions, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Recruiting at 1 site in United States. Open to participants aged 2 Years to 110 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.

Primary conditionMotor Neuron DiseaseRegistry: Neuromuscular DiseasesReclassifiedWhy we changed it
Registry
Neuromuscular Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Motor Neuron Disease
Why
  1. The study's listed conditions name Motor Neuron Disease, a narrower term within Neuromuscular Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Jun 2013; still recruiting 13 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
275
Allocation
Not applicable
Ages
2 Years to 110 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies in Motor Neuron Disease by National Institute of Neurological Disorders and Stroke (NINDS) — 5 open to participants now, 5 under way, none of them phase 3. Motor Neuron Disease · National Institute of Neurological Disorders and Stroke (NINDS).

Started
2013
with 1 other
No phase
Only one
of the 20
Registered
14th of 20
by date

Among the 20 studies in Motor Neuron Disease by National Institute of Neurological Disorders and Stroke (NINDS), this one is one of 2 that started in 2013, is the only one with no phase, and was the 14th registered.

Motor Neuron Disease

203 studies on the registry are indexed under Motor Neuron Disease; 61 are open to participants now.

Browse Motor Neuron Disease studies →

Open to participants now

5 of the 20 studies in Motor Neuron Disease by National Institute of Neurological Disorders and Stroke (NINDS) are open now, in 2 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 43 Motor Neuron Disease studies recruiting now, 29 (67%) set no upper age limit and 2 (5%) stop at 75 or younger; 10 take children under 18; 16 take healthy volunteers.

This study: 2 Years to 110 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 20 studies in Motor Neuron Disease by National Institute of Neurological Disorders and Stroke (NINDS), or all of them as a file.
02

Study 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. 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.
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.

03

Conditions studied

  • Neuromuscular Disease
  • Motor Neuron Disease
  • Inherited Neuromuscular Conditions
  • Inherited Neuropathies

Browse trials for

Keywords

  • Electrophysiology
  • Neuromuscular Disease
04

In context

Motor Neuron Disease Reclassified

203 studies on the registry are indexed under Motor Neuron Disease; 61 are open to participants now.

This study's planned enrollment of 275 is above the median of 30 across 104 interventional studies indexed under Motor Neuron Disease.

Browse Motor Neuron Disease studies →

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS) is the lead sponsor of 601 studies on the registry; 56 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.

Compared within Motor Neuron Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neuromuscular Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
2 Years to 110 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

  • INCLUSION CRITERIA:

HEALTHY VOLUNTEERS-ADULTS

  1. Healthy adults, male or female, aged 18 years old or older,
  2. In good general health as evidenced by medical history
  3. Stated willingness to comply with all study procedures and availability for the duration of the study.
  4. Ability of subject to understand and the willingness to sign a written document.

HEALTHY VOLUNTEERS-PEDIATRIC

  1. Healthy children, male or female, age 7-18,
  2. In good general health as evidenced by medical history
  3. Stated willingness to comply with all study procedures and availability for the duration of the study
  4. 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.

Inclusion criteria

  1. Suspected motor neuron disease or
  2. Suspected myopathy or
  3. Suspected neuropathy or
  4. Suspected movement disorders that impair intracortical processes
  5. Age of 2 years or older
  6. 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.

EXCLUSION CRITERIA:

HEALTHY VOLUNTEERS-ADULTS

  1. Medical conditions that require medications that affects the physiological measures being tested. Some conditions that may be excluded are diabetes, kidney and liver disease.
  2. History of stroke, muscle disorders, peripheral neuropathy or spine surgery

HEALTHY VOLUNTEERS-PEDIATRIC

  1. Medical conditions that require medications that affects the physiological measures being tested. Some conditions that may be excluded are diabetes, kidney and liver disease.
  2. History of stroke, muscle disorders, peripheral neuropathy or spine surgery

SUBJECTS WITH NEUROMUSCULAR DISEASE:

No clinical evidence of a neuromuscular disorder on clinical evaluation.

Terms in these criteria, in plain language(1)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

06

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
275 participants (estimated)

Study arms

  • Experimental
    1/All Subjects

    Healthy Volunteers and patients

    Device: EIM testing · Device: Nerve & muscle ultrasonography · Device: Nerve conduction studies · Device: Electromyography (EMG)

Interventions

  • DeviceEIM testing

    EIM device is placed on the muscle and a high frequency current is delivered to the skin.

  • DeviceNerve & muscle ultrasonography

    Ultrasound waves to examine the muscles and nerves

  • DeviceNerve conduction studies

    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.

  • DeviceElectromyography (EMG)

    Thin needle placed into muscles to record electrical activity-adults only

07

What researchers measure

Primary outcomes

  1. Patients - EIM measures for a selection of muscles

    Obtaining measures using EIM device in different types of neuromuscular disorders.

    Time frame: End of study

  2. 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

    Time frame: End of study

Secondary outcomes

  1. Serial studies in pediatric patients

    Serial measures of EIM in patients with neuromuscular disorders

    Time frame: End of study

  2. 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.

    Time frame: End of study

08

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contactccopr@nih.gov · 800-411-1222
09

References and documents

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 28224647 ↗
  • Schwartz 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 26179210 ↗
  • Offit 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 ↗

Individual participant data

Plan to share: 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.

10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2013 (actual). Primary completion is estimated for Jun 2027, 167 months after the start.

Of 32 interventional studies with no phase under Motor Neuron Disease, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 77. This study's planned 167 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 11, 2013
First posted
Jul 16, 2013
StartActual
Jun 20, 2013
Primary completionEst.
Jun 1, 2027
CompletionEst.
Jun 1, 2027
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT01900132
Responsible party
Sponsor
First posted
Jul 16, 2013
Start date
Jun 20, 2013
Primary completion
Jun 1, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Oct 16, 2026

Study contacts

Candida C Silva
Contact
candida.silva@nih.gov
(301) 496-7428
Tanya J Lehky, M.D.
Contact
lehkyt@ninds.nih.gov
(301) 496-7428
Tanya J Lehky, M.D.
principal investigator · National Institute of Neurological Disorders and Stroke (NINDS)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion