This study is currently recruiting participants.
Number
13-N-0165
Sponsoring Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 2 Years Max Age: 110 Years
Referral Letter Required
No
Population Exclusion(s)
None
Keywords
Electrophysiology; Neuromuscular Disease
Recruitment Keyword(s)
Condition(s)
Neuromuscular Disease; Motor Neuron Disease; Inherited Neuromuscular Conditions; Inherited Neuropathies
Investigational Drug(s)
Investigational Device(s)
Electrical Impedance Myography
Intervention(s)
Device: EIM testing Device: Nerve & muscle ultrasonography Device: Nerve conduction studies Device: Electromyography (EMG)
Supporting Site
National Institute of Neurological Disorders and Stroke
- 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.
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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.
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,
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:
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.
Principal Investigator
Referral Contact
For more information: