Electrical Impedance Myography: Natural History Studies inNeuromuscular Disorders and Healthy Volunteers
2 other identifiers
interventional
275
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 20, 2013
CompletedFirst Submitted
Initial submission to the registry
July 11, 2013
CompletedFirst Posted
Study publicly available on registry
July 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
May 5, 2026
March 20, 2026
13 years
July 11, 2013
May 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Patients - EIM measures for a selection of muscles
Obtaining measures using EIM device in different types of neuromuscular disorders.
End of study
Healthy Volunteers - EIM measures for a selection of muscles with the aim of developing normative values for the NIH EMG lab
Obtaining measures using EIM device- reproducibility and normative data
End of study
Secondary Outcomes (2)
Serial studies in pediatric patients
End of study
Healthy Volunteers - exploratory correlations of ultrasound and electrodiagnostic methods such nerve conduction studies and less likely, EMG
End of study
Study Arms (1)
1/All Subjects
EXPERIMENTALHealthy Volunteers and patients
Interventions
EIM device is placed on the muscle and a high frequency current is delivered to the skin.
Ultrasound waves to examine the muscles and nerves
Small metal disk electrodes attached to wires onto skin to measure how fast nerves conduct electrical impulses and the strength of the connection between nerves and muscles.
Thin needle placed into muscles to record electrical activity-adults only
Eligibility Criteria
You may qualify if:
- HEALTHY VOLUNTEERS-ADULTS
- Healthy adults, male or female, aged 18 years old or older,
- In good general health as evidenced by medical history
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- HEALTHY VOLUNTEERS-PEDIATRIC
- Healthy children, male or female, age 7-18,
- In good general health as evidenced by medical history
- Stated willingness to comply with all study procedures and availability for the duration of the study
- 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.
- Suspected motor neuron disease or
- Suspected myopathy or
- Suspected neuropathy or
- +5 more criteria
You may not qualify if:
- HEALTHY VOLUNTEERS-ADULTS
- Medical conditions that require medications that affects the physiological measures being tested. Some conditions that may be excluded are diabetes, kidney and liver disease.
- History of stroke, muscle disorders, peripheral neuropathy or spine surgery
- HEALTHY VOLUNTEERS-PEDIATRIC
- Medical conditions that require medications that affects the physiological measures being tested. Some conditions that may be excluded are diabetes, kidney and liver disease.
- History of stroke, muscle disorders, peripheral neuropathy or spine surgery
- SUBJECTS WITH NEUROMUSCULAR DISEASE:
- No clinical evidence of a neuromuscular disorder on clinical evaluation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (3)
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, Bonnemann CG, Lehky TJ. Electrical impedance myography in individuals with collagen 6 and laminin alpha-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.
PMID: 28224647BACKGROUNDSchwartz DP, Dastgir J, Salman A, Lear B, Bonnemann 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.
PMID: 26179210BACKGROUNDOffit MB, Wu T, Floeter MK, Lehky TJ. Electrical impedance myography (EIM) in a natural history study of C9ORF72 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: 32312103BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tanya J Lehky, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2013
First Posted
July 16, 2013
Study Start
June 20, 2013
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
May 5, 2026
Record last verified: 2026-03-20