Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance Myography

Amyotrophic Lateral Sclerosis (ALS) Clinical Trial

Official title:

Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance Myography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01803386
• Other study ID #: EIM-002-2011-4
• Secondary ID: 2R44NS070385-02A
• Status: Completed
• Phase: N/A
• First received: February 28, 2013
• Last updated: July 21, 2015
• Start date: January 2013
• Est. completion date: March 2015

Study information

• Verified date: July 2015
• Source: Skulpt, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 85 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Amyotrophic Lateral Sclerosis (ALS)
• Neuromuscular Diseases

Intervention

Device:
• EIM 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.

Locations

Country	Name	City	State
United States	Convergence Medical Devices	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Skulpt, Inc.	National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle health as captured by EIM measurements	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.	One time visit - Day 1	No

External Links

•   Convergence Medical Devices Website