Recruiting

Observational Study

Sponsor:

National Institute of Neurological Disorders and Stroke (NINDS)

Code:

NCT01900132

Conditions

Neuromuscular Disease

Motor Neuron Disease

Inherited Neuromuscular Conditions

Inherited Neuropathies

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Accepted

Interventions

EIM testing

Nerve & muscle ultrasonography

Nerve conduction studies

Electromyography (EMG)

Study Details

Brief 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.

Conditions

Neuromuscular Disease

Motor Neuron Disease

Inherited Neuromuscular Conditions

Inherited Neuropathies

Study ID

NCT01900132

Start date

Jun 20, 2013

Status verified date

Jul 13, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Accepted

  • 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 informed consent 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 disorder 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.

Study Design

Enrollment

275 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 1/All Subjects

Healthy Volunteers and patients

Interventions

EIM testing

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

Nerve & muscle ultrasonography

Ultrasound waves to examine the muscles and nerves

Nerve 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.

Electromyography (EMG)

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

Primary outcome measure

  • Patients - EIM measures for a selection of muscles [ Time Frame: End of study ]
  • Healthy Volunteers - EIM measures for a selection of muscles with the aim of developing normative values for the NIH EMG lab [ Time Frame: End of study ]

Central Contacts and Locations

Central contacts

Candida C Silva

(301) 496-7428candida.silva@nih.gov

Tanya J Lehky, M.D.

(301) 496-7428lehkyt@ninds.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Last update posted

Sep 1, 2026

Last verified

Jul 13, 2026

Keywords

  • Electrophysiology
  • Neuromuscular Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Neurological Disorders and Stroke (NINDS) on 2026-09-01.