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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Study ID
NCT01900132
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
2 Years - 110 Years
Healthy Volunteers
Accepted

Interventions

  • EIM testing — DEVICE
    EIM device is placed on the muscle and a high frequency current is delivered to the skin.
  • Nerve & muscle ultrasonography — DEVICE
    Ultrasound waves to examine the muscles and nerves
  • Nerve conduction studies — DEVICE
    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 Details

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.

Key Dates

Start date
Jun 20, 2013
Status verified
Mar 2026
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
275 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 1/All Subjects
    Healthy Volunteers and patients

Primary Outcome Measure

Patients - EIM measures for a selection of muscles [ Time Frame: End of study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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