An observational study in Muscular Dystrophy, Peripheral Neuropathy and Motor Neuron Disorder, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Recruiting at 1 site in United States. Open to participants aged 18 Years to 110 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Observational
Among 127 studies in Muscular Dystrophies with a site in United States — 32 open to participants now, 43 under way, 2 of them phase 3. Muscular Dystrophies · United States.
Among the 127 studies in Muscular Dystrophies with a site in United States, this one is the 20th largest by planned enrollment of the 44 observational ones that give a count, is one of 13 that started in 2022, is one of 45 observational ones, reaches primary completion later than 12 of the 41 other live ones, and was the 90th registered.
224 studies on the registry are indexed under Muscular Dystrophies; 48 are open to participants now.
Browse Muscular Dystrophies studies →32 of the 127 studies in Muscular Dystrophies with a site in United States are open now. Recruiting first, the newest first:
Johns Hopkins University · Sites in United States
Virginia Commonwealth University · Sites in United States
University of Florida · Sites in United States
Vanderbilt University Medical Center · Sites in United States
National Institutes of Health Clinical Center (CC) · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 38 Muscular Dystrophies studies recruiting now, 14 (37%) set no upper age limit and 15 (39%) stop at 75 or younger; 24 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 110 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
127 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 24 · Phase 2 27 · Phase 3 16 · Phase 4 2
First in 1978; this study’s year is marked. 13 started in 2022.
This study's planned enrollment of 150 is above the median of 111 across 74 observational studies indexed under Muscular Dystrophies.
Median enrollment 41 across the 80 interventional studies, 109 across the 44 observational. Of the 76 that completed or were terminated, 28 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
46 of 127 have an industry lead sponsor. The 10 most frequent:
National Institute of Neurological Disorders and Stroke (NINDS) is the lead sponsor of 601 studies on the registry; 56 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.
National Institute of Neurological Disorders and Stroke (NINDS) has 5 studies filed under Muscular Dystrophies — fewer than ten, so there is no comparison to draw.
13 of the studies in Muscular Dystrophies with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06290713University of FloridaVasodilator and Exercise Study for DMD (VASO-REx) | 2026-11 |
| NCT06185764Vertex Pharmaceuticals IncorporatedA Phase 1/2 Study of VX-670 in Adult Participants With Myotonic Dystrophy 1 (DM1) | 2027-02-02 |
| NCT07287189Satellos Bioscience, Inc.Phase 2 Study of SAT-3247 in Pediatric Ambulatory Patients | 2027-03-31 |
| NCT05854433Wake Forest University Health SciencesBrain Structure and Clinical Endpoints in Myotonic Dystrophy Type 2 | 2027-06 |
| NCT07502989Beth Israel Deaconess Medical CenterMuscle Health Measurements Using Electrical Impedance Myography | 2027-06-01 |
Among the 127 studies in Muscular Dystrophies with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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:
Secondary Objectives:
Exploratory Objectives:
Endpoints:
Primary Endpoint:
Secondary Endpoints:
Reproducibility
Exploratory Endpoint:
Community and participants on other NIH protocols that have neuromuscular disorders.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
EXCLUSION CRITERIA:
Healthy Volunteers-Adults
History of stroke, muscle disorders, peripheral neuropathy, or spine surgery
No clinical evidence of a neuromuscular disorder on clinical evaluation.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnosed with a neuromuscular disorder such as motor neuron disorder, myopathy or have findings consistent with a peripheral neuropathy.
No known abnormal muscle or nerve disorders
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.
Time frame: 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
Time frame: ongoing
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
Time frame: 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
Time frame: ongoing
Plan to share: 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.
Started Apr 2022 (actual). Primary completion is estimated for Aug 2027, 63 months after the start.
Of 37 observational studies under Muscular Dystrophies, half reached primary completion within 113 months of starting (the median), counting those still running; a quarter within 38. This study's planned 63 months is below that.
How these figures are worked out, and which studies are left out of them.
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National Institute of Neurological Disorders and Stroke (NINDS) →