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 volunteersQualifiers
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
Single group
Treatments tested in this trial
EIM testing
DeviceEIM device is placed on the muscle and a high frequency current is delivered to the skin.
Nerve & muscle ultrasonography
DeviceUltrasound waves to examine the muscles and nerves
Nerve conduction studies
DeviceSmall 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)
DeviceThin needle placed into muscles to record electrical activity-adults only
Treatment groups
Trial outcomes
Primary outcomes
Patients - EIM measures for a selection of muscles
Obtaining measures using EIM device in different types of neuromuscular disorders.
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
Secondary outcomes
Serial studies in pediatric patients
Serial measures of EIM in patients with neuromuscular disorders
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.
Sponsors and contacts
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