Evaluating a new device for assessing muscle and nerve disorders
Electrical Impedance Myography: Natural History Studies in Neuromuscular Disorders and Healthy Volunteers
This study is testing a new device that uses electrical signals to see if it can help diagnose muscle and nerve disorders in both healthy people and those with neuromuscular diseases.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 275 (estimated) |
| Ages | 2 Years to 110 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT01900132 on ClinicalTrials.gov |
What this trial studies
This study examines the use of electrical impedance myography (EIM) to evaluate neuromuscular disorders in both healthy volunteers and individuals with various neuromuscular diseases. The research aims to establish normative values and assess the device's ability to differentiate between different types of neuromuscular disorders. Participants will undergo non-invasive testing, including EIM, nerve and muscle ultrasonography, and other electrodiagnostic methods. The study includes both adults and children, allowing for a comprehensive understanding of the device's utility across age groups.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals aged 2 years and older, as well as patients with neuromuscular disorders of any etiology.
Not a fit: Patients without neuromuscular disorders or those who are unable to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, non-invasive method for diagnosing and monitoring neuromuscular disorders.
How similar studies have performed: While the use of electrical impedance myography is a novel approach, similar studies have shown promise in evaluating muscle and nerve conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Tanya J Lehky, M.D. — National Institute of Neurological Disorders and Stroke (NINDS)
- Study coordinator: Candida C Silva
- Email: candida.silva@nih.gov
- Phone: (301) 496-7428
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.