Investigational Use of Neuromuscular Ultrasound

NCT05237973 | Recruiting

• 2 other identifiers: 10000625000625-N
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Current techniques used to measure the health and function of a person s nerves and muscles are generally effective, but they do have limits. Researchers are looking for ways to improve the ability to observe nerves and muscles and how they function in this natural history protocol. Objective: To study the use of ultrasound (sound waves) to learn more about nerves and muscles. Eligibility: Healthy adults, aged 18 and older, with no history of stroke, nerve or muscular disorders, or spine surgery are also needed. A smaller population of adults aged 18 and older who have a neuromuscular disorder or show symptoms of nerve or muscle disorder will also be evaluated. Design: Participants will be screened with a medical record review. Participants will have up to 5 outpatient clinic visits. Most participants will have 1 or 2 visits. Visits will last for less than 3-4 hours each. During each visit, participants will give a brief medical history and have a physical exam. Participants will have ultrasounds to get pictures and measurements of their nerves and muscles. Gel will be applied to their skin. A probe will be placed on the skin surface. Sound waves sent through the probe will be used to create pictures. Participants may have nerve conduction studies. Wires will be taped to the skin surface near a muscle or nerve in the arm or leg. The nerve will be stimulated with a small electric current that feels like a rubber band flick. The response will be recorded through the wires.

Conditions

Muscular Dystrophy; Peripheral Neuropathy; Normal Physiology; Motor Neuron Disorder

Keywords

Neuromuscular; Ultrasound; Elastography; Muscle; Nerve; Natural History

Outcome Measures

Primary Outcomes (2)

• To collect normal values of M-mode diaphragm imaging during quiet and deep breathing and voluntary sniff testing in a population of health controls to establish normal values.

  Normative values for M-mode imaging of the diaphragm in a population of healthy controls.

  ongoing

• To acquire normative values for B-mode imaging of nerves (fascicle count) and muscles (quantitative echotexture measurement) and shear wave elastography data on muscle and nerve stiffness/speed of sound in a population of healthy volunteers.

  Normative values for muscle and nerve shear wave elastography in a population of normal volunteers Normative values for nerve fascicular count in a population of normal volunteers

  ongoing

Secondary Outcomes (2)

• To determine the reproducibility of specialized techniques involving ultrasound of muscle and nerve: shear wave elastography in muscles and nerves, nerve fascicle counts

  ongoing

• To determine the presence or absence of low flow microvascular flow within nerves of a population of healthy volunteers

  ongoing

Study Arms (2)

Neuromuscular disorders

Diagnosed with a neuromuscular disorder such as motor neuron disorder, myopathy or have findings consistent with a peripheral neuropathy.

Normal volunteers

No known abnormal muscle or nerve disorders

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community and participants on other NIH protocols that have neuromuscular disorders.

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Healthy Volunteers-Adults
• Healthy adults, male or female, aged 18 years old or older,
• In good general health as evidenced by medical history, medical conditions under control such as hypertension acceptable.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Ability of subject to understand and the willingness to sign a written informed consent document.
• Participants with neuromuscular disorders
• Adults, male or female, aged 18 years old or older,
• Diagnosed with a neuromuscular disorder or have signs and symptoms of nerve or muscle disorder or neuromuscular diaphragm dysfunction.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Ability of subject to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Healthy Volunteers-Adults
• History of stroke, muscle disorders, peripheral neuropathy, or spine surgery
• Participants with neuromuscular disorders
• No clinical evidence of a neuromuscular disorder on clinical evaluation.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (3)

• Creze M, Nordez A, Soubeyrand M, Rocher L, Maitre X, Bellin MF. Shear wave sonoelastography of skeletal muscle: basic principles, biomechanical concepts, clinical applications, and future perspectives. Skeletal Radiol. 2018 Apr;47(4):457-471. doi: 10.1007/s00256-017-2843-y. Epub 2017 Dec 9.

  PMID: 29224123 BACKGROUND

• Saade DN, Neuhaus SB, Foley AR, Bonnemann CG. The Use of Muscle Ultrasound in the Diagnosis and Differential Diagnosis of Congenital Disorders of Muscle in the Age of Next Generation Genetics. Semin Pediatr Neurol. 2019 Apr;29:44-54. doi: 10.1016/j.spen.2019.01.001. Epub 2019 Jan 16.

  PMID: 31060725 BACKGROUND

• Hobson-Webb LD. Emerging technologies in neuromuscular ultrasound. Muscle Nerve. 2020 Jun;61(6):719-725. doi: 10.1002/mus.26819.

  PMID: 32012298 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Muscular Dystrophies; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Tanya J Lehky, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Candida C Silva

CONTACT

(301) 496-7428; candida.silva@nih.gov

Tanya J Lehky, M.D.

CONTACT

(301) 496-7428; lehkyt@ninds.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 14, 2022
• Study Start: April 18, 2022
• Primary Completion: August 3, 2026
• Study Completion: August 3, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04-17

Locations

US (1)