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Protocol Details

Investigational use of Neuromuscular Ultrasound

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000625-N

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 110 Years

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Muscular Dystrophy;
Peripheral neuropathy;
Motor neuron disorder;
Normal Physiology

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

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.

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Eligibility

INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

a. 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.

b. 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:

a. Healthy Volunteers-Adults

History of stroke, muscle disorders, peripheral neuropathy, or spine surgery

b. Participants with neuromuscular disorders

No clinical evidence of a neuromuscular disorder on clinical evaluation.


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Citations:

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Contacts:

Principal Investigator

Referral Contact

For more information:

Tanya J. Lehky, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
NIHBC 10 - CRC BG RM 7-5680
10 CENTER DR
BETHESDA MD 20892
(301) 496-7428
lehkyt@ninds.nih.gov

Candida Silva
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7-5680
10 Center Drive
Bethesda, Maryland 20892
(301) 496-7428
candida.silva@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT05237973

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