Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance Myography

Study Purpose:

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.

Study Status:

Not recruiting


Amyotrophic Lateral Sclerosis (ALS)

Study Type:


Type of Intervention:


Intervention Name:






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

Erik Ensrud, MD, VA Boston Healthcare System ID:


Neals Affiliated?


Coordinating Center Contact Information

Convergence Medical Devices

Boston, Massachusetts, 02210 United States

Full Study Summary:

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 Sponsor:

Skulpt, Inc.

Participant Duration:

One Visit

Estimated Enrollment:


Estimated Study Start Date:

12 / 31 / 2012

Estimated Study Completion Date:

03 / 01 / 2015

Posting Last Modified Date:

07 / 22 / 2015

Date Study Added to

03 / 04 / 2013

Minimum Age:

21 Years

Maximum Age:

85 Years

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

Convergence Medical Devices

Boston, Massachusetts 02210
United States