Evaluating a new device for assessing muscle and nerve disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

* 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 disorders 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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.