Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance Myography

Completed

• Conditions: Amyotrophic Lateral Sclerosis (ALS)
• Interventions: Device: EIM Measurements

• Registration Number: NCT01803386
• Lead Sponsor: Skulpt, Inc.

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-28
• Study First Submitted QC: 2013-03-01
• Study First Posted: 2013-03-04
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-21
• Last Update Posted: 2015-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ALS Subjects	EIM Measurements	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.
Healthy Subjects	EIM Measurements	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Convergence Medical Devices; 🇺🇸 Boston, Massachusetts, United States