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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-110
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

275 Participants
are divided into 1 treatment group
Group A: 1/All SubjectsExperimental treatment 4 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

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