Electrical Impedance Myography: Natural History Studies inNeuromuscular Disorders and Healthy Vol… (NCT01900132) | Clinical Trial Compass
RecruitingNot Applicable
Electrical Impedance Myography: Natural History Studies inNeuromuscular Disorders and Healthy Volunteers
United States275 participantsStarted 2013-06-20
Plain-language 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.
Who can participate
Age range
2 Years – 110 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Healthy children, male or female, age 7-18,
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patients - EIM measures for a selection of muscles
Timeframe: 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
Timeframe: End of study
Trial details
NCT IDNCT01900132
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
. Ability of subject or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.
Exclusion criteria
. 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