NCT05237973 Investigational Use of Neuromuscular Ultrasound
| NCT ID | NCT05237973 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Neurological Disorders and Stroke (NINDS) |
| Condition | Muscular Dystrophy |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2022-04-18 |
| Primary Completion | 2027-08-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2022-04-18 with a primary completion date of 2027-08-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Tanya J Lehky, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)
Frequently Asked Questions
Who can join the NCT05237973 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 110 Years, studying Muscular Dystrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05237973 currently recruiting?
Yes, NCT05237973 is actively recruiting participants. Contact the research team at candida.silva@nih.gov for enrollment information.
Where is the NCT05237973 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT05237973 clinical trial?
NCT05237973 is sponsored by National Institute of Neurological Disorders and Stroke (NINDS). The principal investigator is Tanya J Lehky, M.D. at National Institute of Neurological Disorders and Stroke (NINDS). The trial plans to enroll 150 participants.