Using ultrasound to study nerves and muscles

Investigational Use of Neuromuscular Ultrasound

This study is testing how ultrasound can help us learn more about the health of nerves and muscles in both healthy adults and those with neuromuscular disorders.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years to 110 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT05237973 on ClinicalTrials.gov

What this trial studies

This observational study aims to improve the understanding of nerve and muscle health by utilizing advanced ultrasound imaging techniques. Researchers will evaluate healthy adults and those with neuromuscular disorders to gather normative data on muscle and nerve structure and function. Participants will undergo medical history reviews and physical exams during outpatient visits, where various ultrasound modalities will be employed to assess nerve and muscle characteristics. The goal is to identify reliable biomarkers that can enhance clinical evaluations of neuromuscular diseases.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18 and older, as well as adults with diagnosed neuromuscular disorders or symptoms of nerve or muscle dysfunction.

Not a fit: Patients with a history of stroke, significant nerve or muscular disorders, or spine surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic tools for neuromuscular disorders, enhancing patient care and treatment outcomes.

How similar studies have performed: While the use of ultrasound in neuromuscular evaluations is established, this specific approach to defining biomarkers through advanced imaging techniques is relatively novel.

Eligibility criteria

* INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. 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, medical conditions under control such as hypertension acceptable.
   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.
2. Participants with neuromuscular disorders

   1. Adults, male or female, aged 18 years old or older,
   2. Diagnosed with a neuromuscular disorder or have signs and symptoms of nerve or muscle disorder or neuromuscular diaphragm dysfunction.
   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.

EXCLUSION CRITERIA:

1. Healthy Volunteers-Adults

   History of stroke, muscle disorders, peripheral neuropathy, or spine surgery
2. Participants with neuromuscular disorders

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

Conditions Muscular Dystrophy; Peripheral Neuropathy; Motor Neuron Disorder; Normal Physiology; Neuromuscular; Ultrasound; Elastography; Muscle