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

Launched by NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) · Jul 11, 2013

Keywords

ClinConnect Summary

This clinical trial is studying a new technique called Electrical Impedance Myography (EIM) to see how it can help evaluate muscle and nerve disorders. EIM works by using a mild, painless electrical current to assess how well electricity moves through muscles. Researchers want to gather experience with this device by testing it on both healthy individuals and those with various neuromuscular diseases. The trial will include participants aged 2 years and older, including children and adults, who are either healthy or have a neuromuscular condition, such as motor neuron disease or inherited neuropathies.

Participants in the trial will undergo a thorough medical history review and a physical exam during a clinic visit that lasts about 2-3 hours. They will have the EIM device applied to their skin, which will not cause any discomfort, along with possible additional tests like ultrasounds and nerve assessments. This study is noninvasive, meaning it does not involve any painful procedures. Overall, this trial aims to learn more about using EIM in testing muscle and nerve health, which could lead to better evaluations and treatments in the future.

Gender

ALL

Eligibility criteria

• * 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.