Electrical Impedance Myography: Exploratory Studies in Normal Subjects and Patients With Neuromuscular Disorders

Study Purpose:

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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS, Healthy Volunteer

Study Type:

Interventional Trial

Study Category:

Device

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Tanya J Lehky, M.D. National Institute of Neurological Disorders and Stroke (NINDS)

Clinicaltrials.gov ID (11 digit #):

NCT01900132

Neals Affiliated?

No

Coordinating Center Contact Information

National Institutes of Health Clinical Center
Candida Silva / .(JavaScript must be enabled to view this email address) / 301-496-8295
Tanya J Lehky, M.D. / .(JavaScript must be enabled to view this email address) / 301-496-7428
Bethesda, Maryland 20892 United States

Full Study Summary:

Objective: This is an observational exploratory protocol for the use of electrical impedance myography (EIM) device in the study of neuromuscular disorders. The aim is to gain proficiency in the use of EIM device initially with healthy volunteers and try to correlate its use with other modalities such as muscle ultrasound and electrodiagnostic techniques. We will extend this into the investigation of subjects with a variety of neuromuscular disease.

Study: 125 healthy volunteers and 150 subjects with neuromuscular disease. The subjects will be adults and children, healthy volunteers and subjects with neuromuscular disease. Initially, we will evaluate the EIM in healthy volunteers. Since the advantage of the EIM is that it is noninvasive and nonpainful, we will be evaluating pediatric population.

Design: The studies will be performed in the outpatient clinic. For the healthy volunteers we will be evaluating EIM along with possible ultrasound and electrodiagnostic methods. A single session will be 3 hours or less. Repeat studies may be performed to establish reproducibility after the initial studies are completed. For subjects with neuromuscular disease, the studies will be conducted in a single outpatient session of 3 hours or less, unless a follow-up study is requested by the primary team. For children, the session will be 2 hours or less.

Outcome measures: This is an exploratory protocol for the use of the EIM device. We aim to develop lab normative values for EIM using healthy volunteers. We have developed lab normative values for EIM using healthy volunteers for our older EIM sensors but are still collecting data for our new EIM sensor. For subjects with neuromuscular disease we aim to understand the value of EIM as a type of biomarker for different neuromuscular disorders. Eventually, we would like to incorporate EIM into clinical trials as a biomarker though this is not within the scope of the current protocol. As secondary outcome measures, we will explore correlations between EIM and ultrasound and other electrodiagnostic methods.

Study Sponsor:

National Institute of Neurological Disorders and Stroke (NINDS)

Participant Duration:

Estimated Enrollment:

275

Estimated Study Start Date:

06/06/2013

Estimated Study Completion Date:

01/01/2023

Posting Last Modified Date:

10/19/2020

Date Study Added to alsconsortium.org:

10/19/2020
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    2

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    HEALTHY VOLUNTEERS-ADULTS

    INCLUSION CRITERIA:

    Healthy adults, aged 18- or older, willing to participate

    EXCLUSION CRITERIA:

    Medical conditions that require medications that affect 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 who are unable to provide informed consent

    HEALTHY VOLUNTEERS-PEDIATRIC

    INCLUSION CRITERIA:

    Healthy children, age 7-18, willing to participate

    EXCLUSION CRITERIA:

    Medical conditions that require medications that affect 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 who are unable to provide informed consent or assent

    SUBJECTS WITH NEUROMUSCULAR DISEASE

    INCLUSION CRITERIA:

    Suspected motor neuron disease or
    Suspected myopathy or
    Suspected neuropathy or
    Suspected movement disorders that impair intracortical processes
    Age of 2 years or older
    Subjects who are unable to provide consent may be included if they have the appropriate Durable Power of Attorney (DPA).

    EXCLUSION CRITERIA:

    You may not be eligible for this study if we are unable to obtain informed consent.

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

  • Site Contact Information

    National Institutes of Health Clinical Center
    .(JavaScript must be enabled to view this email address) / 800-411-1222 ext TTY8664111010
    Bethesda, Maryland 20892
    United States