Muscular DystrophyNCT05237973
Investigational Use of Neuromuscular Ultrasound
An observational study of Muscular Dystrophy and Peripheral Neuropathy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscular Dystrophy, Peripheral Neuropathy, Motor Neuron Disorder
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2022to 3 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community and participants on other NIH protocols that have neuromuscular disorders.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
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.
Read more
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.
Read the detailed description
Study Description:
Currently there are a limited number of biomarkers that can provide quantitative, reliable information about nerve and muscle function and structure in patients with neuromuscular diseases. This protocol aims to investigate and define specific ultrasound imaging techniques of nerves and muscles that may be useful as biomarkers in clinical trials. For nerve studies, we aim to evaluate the use of high resolution ultrasound probes for B-mode imaging including cross sectional area, diameter and nerve fascicle counts. Additional imaging modalities will be evaluated including shear wave elastography and low flow microvascular imaging. Ultrasound modalities for muscle imaging will include B-mode imaging, muscle thickness, echo-intensity and or shear wave imaging and low flow microvascular imaging. The hypothesis for incorporating these ultrasound imaging modalities into neuromuscular evaluations is these techniques can provide unique quantitative, reproducible data about the structure of nerves and muscles. This information can be used to compare patients with controls and measure change in these modalities in neuromuscular disease states and determine if these measures can serve as a reliable biomarker in neuromuscular diseases.
Objectives:
Primary Objectives:
- To acquire normative values for elastography of muscle in a population of healthy volunteers
- To acquire normative values for elastography of nerve in a population of healthy volunteers
- To acquire normative values of nerve fascicular count in a population of healthy volunteers
- 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.
Secondary Objectives:
- To determine the reproducibility of specialized techniques involving ultrasound of muscle and nerve: shear wave elastography in muscles and nerves, nerve fascicle counts
- To determine the presence or absence of low flow microvascular flow within nerves of a population of healthy volunteers
Exploratory Objectives:
- To compare shear wave elastography values (kPa, meters/second) with standard nerve conduction values; amplitude and nerve conduction velocities in healthy controls and participants with neuromuscular diseases.
- To compare shear wave elastography values with muscle thickness, echotexture and Heckmatt Scale values
- To compare shear wave elastography values (kPa, meters/second), nerve fascicle count and microvascular flow between volunteers with participants with neuromuscular disorders
- To compare B-mode quantitative measures of muscle in healthy controls and participants with neuromuscular diseases.
- To compare M-mode imaging values of diaphragm (excursion of movement) during quiet and deep breathing and voluntary sniff tests in healthy controls and patients with neuromuscular diseases.
- To quantitate the low flow microvascularity in nerves and muscles in healthy volunteers
- To develop a method for automated analysis of peripheral nerves that would allow for reproducible and refined imaging of nerves.
Endpoints:
Primary Endpoint:
- Muscle (deltoid, triceps, bicep, flexor carpi radialis, extensor digitorum communis, first dorsal interossei, rectus femoris, semimembranosus, tibialis anterior, medial gastrocnemius)elastography (m/s)
- Nerve (median and ulnar in the forearm, tibial in the calf) elastography (m/s)
- Nerve fascicular count (median and ulnar at wrist, tibial at ankle) in a population of normal volunteers (binary)
- M-mode diaphragm imaging during quiet and deep breathing and voluntary sniff testing in a population of health volunteers
Secondary Endpoints:
- Reproducibility
- Muscle elastography (m/s)
- Nerve elastography (m/s)
- Nerve fascicle counts (#)
- Presence of low flow microvascularity in nerves (binary value)
Exploratory Endpoint:
- Amplitude (mV) and conduction velocity (m/s) obtained from standard nerve conduction studies and nerve elastography values (m/s) obtained from specialized techniques (median, ulnar, tibial)
- Ultrasound data on muscle thickness (mm) and Heckmatt Scale values (1-4)
- Nerve elastography (m/s), fascicular count (#), and microvascular flow (binary-yes/no)
- Muscle elastography (m/s), thickness (mm), Heckmatt scale
- M-mode imaging values of diaphragm (excursion of movement) during quiet and deep breathing and voluntary sniff tests
- Quantitative values of low flow microvascularity in muscles and nerves
- Reproducible ability to identify nerve and/or nerve associated structures using automated analysis
- Keywords
- Neuromuscular, Ultrasound, Elastography, Muscle, Nerve, Natural History
- Medical subject headings
- Muscular Dystrophies, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Reproducibility of muscle and nerve shear wave elastography (meters/sec or kPa ) Reproducibility of nerve fascicle counts
Measured: ongoing
To determine the presence or absence of low flow microvascular flow within nerves of a population of healthy volunteers
Presence of low flow microvascularity in nerves in healthy volunteers
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start18 Apr 2022
- Primary completion3 Aug 2027 (estimated)
- Study completion3 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Muscular DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Tanya J Lehky, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237973
- Sponsor's protocol ID
- 10000625
- Other IDs
- 000625-N
- Status last verified
- 15 Sep 2026
- First submitted
- 9 Feb 2022
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Specific plan to make the IPD has not be made. This will have to be considered if the data is involved in a publication or other larger analysis.
Publications
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.
PubMed 29224123Saade 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.
PubMed 31060725Hobson-Webb LD. Emerging technologies in neuromuscular ultrasound. Muscle Nerve. 2020 Jun;61(6):719-725. doi: 10.1002/mus.26819.
PubMed 32012298
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigational Use of Neuromuscular Ultrasound
- ClinicalTrials.gov ID
- NCT05237973
- Acronym / sponsor ID
- 10000625
- Keywords
- Neuromuscular, Ultrasound, Elastography, Muscle, Nerve, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 3 Aug 2027 (estimated)
- Study completion
- 3 Aug 2027 (estimated)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Description:
Currently there are a limited number of biomarkers that can provide quantitative, reliable information about nerve and muscle function and structure in patients with neuromuscular diseases. This protocol aims to investigate and define specific ultrasound imaging techniques of nerves and muscles that may be useful as biomarkers in clinical trials. For nerve studies, we aim to evaluate the use of high resolution ultrasound probes for B-mode imaging including cross sectional area, diameter and nerve fascicle counts. Additional imaging modalities will be evaluated including shear wave elastography and low flow microvascular imaging. Ultrasound modalities for muscle imaging will include B-mode imaging, muscle thickness, echo-intensity and or shear wave imaging and low flow microvascular imaging. The hypothesis for incorporating these ultrasound imaging modalities into neuromuscular evaluations is these techniques can provide unique quantitative, reproducible data about the structure of nerves and muscles. This information can be used to compare patients with controls and measure change in these modalities in neuromuscular disease states and determine if these measures can serve as a reliable biomarker in neuromuscular diseases.
Objectives:
Primary Objectives:
- To acquire normative values for elastography of muscle in a population of healthy volunteers
- To acquire normative values for elastography of nerve in a population of healthy volunteers
- To acquire normative values of nerve fascicular count in a population of healthy volunteers
- 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.
Secondary Objectives:
- To determine the reproducibility of specialized techniques involving ultrasound of muscle and nerve: shear wave elastography in muscles and nerves, nerve fascicle counts
- To determine the presence or absence of low flow microvascular flow within nerves of a population of healthy volunteers
Exploratory Objectives:
- To compare shear wave elastography values (kPa, meters/second) with standard nerve conduction values; amplitude and nerve conduction velocities in healthy controls and participants with neuromuscular diseases.
- To compare shear wave elastography values with muscle thickness, echotexture and Heckmatt Scale values
- To compare shear wave elastography values (kPa, meters/second), nerve fascicle count and microvascular flow between volunteers with participants with neuromuscular disorders
- To compare B-mode quantitative measures of muscle in healthy controls and participants with neuromuscular diseases.
- To compare M-mode imaging values of diaphragm (excursion of movement) during quiet and deep breathing and voluntary sniff tests in healthy controls and patients with neuromuscular diseases.
- To quantitate the low flow microvascularity in nerves and muscles in healthy volunteers
- To develop a method for automated analysis of peripheral nerves that would allow for reproducible and refined imaging of nerves.
Endpoints:
Primary Endpoint:
- Muscle (deltoid, triceps, bicep, flexor carpi radialis, extensor digitorum communis, first dorsal interossei, rectus femoris, semimembranosus, tibialis anterior, medial gastrocnemius)elastography (m/s)
- Nerve (median and ulnar in the forearm, tibial in the calf) elastography (m/s)
- Nerve fascicular count (median and ulnar at wrist, tibial at ankle) in a population of normal volunteers (binary)
- M-mode diaphragm imaging during quiet and deep breathing and voluntary sniff testing in a population of health volunteers
Secondary Endpoints:
- Reproducibility
- Muscle elastography (m/s)
- Nerve elastography (m/s)
- Nerve fascicle counts (#)
- Presence of low flow microvascularity in nerves (binary value)
Exploratory Endpoint:
- Amplitude (mV) and conduction velocity (m/s) obtained from standard nerve conduction studies and nerve elastography values (m/s) obtained from specialized techniques (median, ulnar, tibial)
- Ultrasound data on muscle thickness (mm) and Heckmatt Scale values (1-4)
- Nerve elastography (m/s), fascicular count (#), and microvascular flow (binary-yes/no)
- Muscle elastography (m/s), thickness (mm), Heckmatt scale
- M-mode imaging values of diaphragm (excursion of movement) during quiet and deep breathing and voluntary sniff tests
- Quantitative values of low flow microvascularity in muscles and nerves
- Reproducible ability to identify nerve and/or nerve associated structures using automated analysis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community and participants on other NIH protocols that have neuromuscular disorders.
Key inclusion criteria (11 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Healthy Volunteers-Adults
- Participants with neuromuscular disorders
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: ongoing
Normative values for M-mode imaging of the diaphragm in a population of healthy controls.
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.
Time frame: ongoing
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
2 secondary outcomes
To determine the reproducibility of specialized techniques involving ultrasound of muscle and nerve: shear wave elastography in muscles and nerves, nerve fascicle counts
Time frame: ongoing
To determine the presence or absence of low flow microvascular flow within nerves of a population of healthy volunteers
Time frame: ongoing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 29224123Creze 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.
- Background: PubMed 31060725Saade 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.
- Background: PubMed 32012298Hobson-Webb LD. Emerging technologies in neuromuscular ultrasound. Muscle Nerve. 2020 Jun;61(6):719-725. doi: 10.1002/mus.26819.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Specific plan to make the IPD has not be made. This will have to be considered if the data is involved in a publication or other larger analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tanya J Lehky, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscular Dystrophy and Peripheral Neuropathy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Candida C Silva ((301) 496-7428, candida.silva@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: ongoing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05237973, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.