Amyotrophic Lateral Sclerosis (ALS)
Conditions
Keywords
ALS, EIM
Brief summary
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
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.
Interventions
DEVICEEIM Measurements
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.
Sponsors
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Skulpt, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle health as captured by EIM measurements | One time visit - Day 1 | 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. |
Countries
United States
Outcome results
None listed