Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance Myography

July 21, 2015 updated by: Skulpt, Inc.
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02210
        • Convergence Medical Devices

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ALS Patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ALS Subjects
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.
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.
Other Names:
  • Electrical Impedance Myography Measurements
Healthy Subjects
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.
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.
Other Names:
  • Electrical Impedance Myography Measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One time visit - Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Skulpt, Inc.

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Erik Ensrud, MD, VA Boston Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

February 28, 2013

First Submitted That Met QC Criteria

March 1, 2013

First Posted (Estimate)

March 4, 2013

Study Record Updates

Last Update Posted (Estimate)

July 22, 2015

Last Update Submitted That Met QC Criteria

July 21, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EIM-002-2011-4
  • 2R44NS070385-02A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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