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Electrical Impedance Myography: Natural History Studies inNeuromuscular Disorders and Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01900132
Recruitment Status : Recruiting
First Posted : July 16, 2013
Last Update Posted : February 7, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

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.

Condition or disease Intervention/treatment Phase
Neuromuscular Disease Motor Neuron Disease Inherited Neuromuscular Conditions Inherited Neuropathies Device: EIM testing Device: Nerve & muscle ultrasonography Device: Nerve conduction studies Device: Electromyography (EMG) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 275 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Electrical Impedance Myography: Natural History Studies in Neuromuscular Disorders and Healthy Volunteers
Actual Study Start Date : June 20, 2013
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024


Arm Intervention/treatment
Experimental: 1/All Subjects
Healthy Volunteers and patients
Device: EIM testing
EIM device is placed on the muscle and a high frequency current is delivered to the skin.

Device: Nerve & muscle ultrasonography
Ultrasound waves to examine the muscles and nerves

Device: Nerve conduction studies
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.

Device: Electromyography (EMG)
Thin needle placed into muscles to record electrical activity-adults only




Primary Outcome Measures :
  1. Patients - EIM measures for a selection of muscles [ Time Frame: End of study ]
    Obtaining measures using EIM device in different types of neuromuscular disorders.

  2. Healthy Volunteers - EIM measures for a selection of muscles with the aim of developing normative values for the NIH EMG lab [ Time Frame: End of study ]
    Obtaining measures using EIM device- reproducibility and normative data


Secondary Outcome Measures :
  1. Serial studies in pediatric patients [ Time Frame: End of study ]
    Serial measures of EIM in patients with neuromuscular disorders

  2. Healthy Volunteers - exploratory correlations of ultrasound and electrodiagnostic methods such nerve conduction studies and less likely, EMG [ Time Frame: End of study ]
    Obtaining measures using EIM device and comparing with ultrasound and motor unit number estimation techniques.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01900132


Contacts
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Contact: Candida Silva (301) 496-7428 candida.silva@nih.gov
Contact: Tanya J Lehky, M.D. (301) 496-7428 lehkyt@ninds.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY dial 711    ccopr@nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Tanya J Lehky, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
Additional Information:
Publications:
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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT01900132    
Other Study ID Numbers: 130165
13-N-0165
First Posted: July 16, 2013    Key Record Dates
Last Update Posted: February 7, 2023
Last Verified: January 31, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: .There is no formalized plan to make IPD available of a website. The data from this protocol would be available in anonomyzed format in relationship to publications.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Electrophysiology
Neuromuscular Disease
Additional relevant MeSH terms:
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Neuromuscular Diseases
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Neurodegenerative Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases