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
Disease:
Amyotrophic Lateral Sclerosis (ALS)
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Erik Ensrud, MD, VA Boston Healthcare System
Clinicaltrials.gov ID:
Neals Affiliated?
No
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:
20
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 neals.org:
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