Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance Myography
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Sponsor
- Skulpt, Inc.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Muscle health as captured by EIM measurements
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Muscle health as captured by EIM measurements
Time Frame: 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.