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Protocol Details

Electrical Impedance Myography: Natural History Studies in Neuromuscular Disorders and Healthy Volunteers

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-N-0165

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 2
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Electrophysiology;
Neuromuscular Disease

Recruitment Keyword(s)

None

Condition(s)

Neuromuscular Disease;
Motor Neuron Disease;
Inherited Neuromuscular Conditions;
Inherited Neuropathies

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Device: EIM testing
Device: Nerve & muscle ultrasonography
Device: Nerve conduction studies
Device: Electromyography (EMG)

Supporting Site

National Institute of Neurological Disorders and Stroke

Background:

- Electrical impedance myography (EIM) is a new technique being studied to see if it is helpful in evaluating muscle disorders and nerve disorders. EIM looks at how a mild, painless electrical current travels through muscles. Researchers want to gain experience in using the EIM device. They will collect information on the results of using it on people with and without nerve and muscle diseases, and compare that with information from other standard tests. First, they will test the device on healthy people. Then they will test people with a variety of neuromuscular diseases. Because the test is noninvasive and not painful, researchers will test both children and adults.

Objectives:

- To gain experience using the EIM muscle testing device.

Eligibility:

- Healthy volunteers at least 2 years old.

- Individuals at least 2 years old who have neuromuscular disease.

Design:

- Participants will be screened with a medical history and physical exam.

- Participants will have one 2-3 hour clinic visit. Researchers may request follow-up visits.

- Participants will be tested with the EIM device. The device and small electrodes will be placed on their skin. An electric current will pass through the device, but the participants will not feel this.

- Participants may have an ultrasound test. A gel will be put on their skin, and a device will be moved over the skin.

- Participants may have a nerve test. Electrodes will be placed on their skin, and they will feel a small shock.

- Participants may have a test where a thin needle is inserted in their muscle.

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Eligibility

INCLUSION CRITERIA:

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

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.

HEALTHY VOLUNTEERS-PEDIATRIC

1. Healthy children, male or female, age 7-18,

2. In good general health as evidenced by medical history

3. Stated willingness to comply with all study procedures and availability for the duration of the study

4. Ability of subject or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.

SUBJECTS WITH NEUROMUSCULAR DISEASE

Adult and pediatric, male or female, patients with a neuromuscular disorder are eligible even if the exact etiology of the disorder is unknown at the time of enrollment into this study. This will include neuropathy, myopathy and motor neuron disorders. It is expected that the subjects are undergoing appropriate standard diagnostic and genetic work-up outside of this protocol that will later clarify the specific etiology of the disorder. Movement disorder will also be included because of the prior research done on dystonia and EIM.

Inclusion criteria

1. Suspected motor neuron disease or

2. Suspected myopathy or

3. Suspected neuropathy or

4. Suspected movement disorders that impair intracortical processes

5. Age of 2 years or older

6. Ability of subject to sign a written informed consent document.

NIH EMPLOYEES:

NIH employees and staff may participate, however EMG Section, OCD, NINDS, employees may not participate.

EXCLUSION CRITERIA:

HEALTHY VOLUNTEERS-ADULTS

1. Medical conditions that require medications that affects the physiological measures being tested. Some conditions that may be excluded are diabetes, kidney and liver disease.

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

HEALTHY VOLUNTEERS-PEDIATRIC

1. Medical conditions that require medications that affects the physiological measures being tested. Some conditions that may be excluded are diabetes, kidney and liver disease.

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

SUBJECTS WITH NEUROMUSCULAR DISEASE:

No clinical evidence of a neuromuscular disorder on clinical evaluation.


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Citations:

Nichols C, Jain MS, Meilleur KG, Wu T, Collins J, Waite MR, Dastgir J, Salman A, Donkervoort S, Duong T, Keller K, Leach ME, Lott DJ, McGuire MN, Nelson L, Rutkowski A, Vuillerot C, B(SqrRoot)(Delta)nnemann CG, Lehky TJ. Electrical impedance myography in individuals with collagen 6 and laminin -2 congenital muscular dystrophy: a cross-sectional and 2-year analysis. Muscle Nerve. 2018 Jan;57(1):54-60. doi: 10.1002/mus.25629. Epub 2017 Apr 25.

Schwartz DP, Dastgir J, Salman A, Lear B, B(SqrRoot)(Delta)nnemann CG, Lehky TJ. Electrical impedance myography discriminates congenital muscular dystrophy from controls. Muscle Nerve. 2016 Mar;53(3):402-6. doi: 10.1002/mus.24770. Epub 2015 Aug 13.

Offit MB, Wu T, Floeter MK, Lehky TJ. Electrical impedance myography (EIM) in a natural history study of <i>C9ORF72</i> mutation carriers. Amyotroph Lateral Scler Frontotemporal Degener. 2020 Aug;21(5-6):445-451. doi: 10.1080/21678421.2020.1752247. Epub 2020 Apr 21. PMID: 32312103; PMCID: PMC8340645.

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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)
BG 10-CRC RM 7-5680
10 CENTER DR
BETHESDA MD 20814
(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) 496-8295
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: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT01900132

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