Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance Myography

Study Overview
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Brief Summary
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The purpose of this protocol is to test a new Electrical Impedance Myography (EIM) device and study its reliability and ability to differentiate ALS patients from healthy controls.

Detailed Description
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Investigators will study 10 ALS patients and at least 10 age-matched healthy controls between the ages of 21 and 85 years old. For all subjects, EIM measurements will be performed on four muscles: two in the upper and two in the lower extremities, using 8 different EIM sensors. Measurements will be repeated one time.

Official Title
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Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance Myography

Conditions
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Amyotrophic Lateral Sclerosis (ALS)

Intervention / Treatment
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* Device: EIM Measurements


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of probable or definite ALS by the El Escorial Criteria Exclusion Criteria: History of superimposed generalized neuromuscular disease Primary lateral sclerosis or other atypical motor neuron disorders Forced vital capacity of less than 50% Presence of disease for greater than 5 years since symptom onset

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ALS Subjects<br>EIM measurements will be taken on two upper and two lower extremity muscles with several different electrode arrays. The ALSFRS-R will also be administered. Subcutaneous fat measurement will also be performed on all four muscles using skinfold calipers. | Device: EIM Measurements<br>* EIM measurements are taken by applying saline to the skin and placing a sensor on patients' muscles that will record electrical activity. Electrical current is generated by this machine, but patients will not be able to feel it. The electrical activity recorded is returned to the machine and analyzed by a computer.<br>* Other names: Electrical Impedance Myography Measurements;|
| Healthy Subjects<br>EIM measurements will be taken on two upper and two lower extremity muscles with several different electrode arrays. Subcutaneous fat measurement will also be performed on all four muscles using skinfold calipers. | Device: EIM Measurements<br>* EIM measurements are taken by applying saline to the skin and placing a sensor on patients' muscles that will record electrical activity. Electrical current is generated by this machine, but patients will not be able to feel it. The electrical activity recorded is returned to the machine and analyzed by a computer.<br>* Other names: Electrical Impedance Myography Measurements;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle health as captured by EIM measurements | EIM measurements will be performed with several electrode arrays at one visit per patient. The data captured from ALS and healthy subjects will be used to refine and finalize electrode array design development for the EIM system. | One time visit - Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALS, EIM