Investigational Use of Neuromuscular Ultrasound
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-110
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Healthy Volunteers-Adults
Participants with neuromuscular disorders
Trial population
Community and participants on other NIH protocols that have neuromuscular disorders.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 2 trial groupsGroup A: Neuromuscular disorders
Group B: Normal volunteers
Trial outcomes
Primary outcomes
1
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
ongoing2
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
ongoingSecondary outcomes
1
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
ongoing2
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
ongoingSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov