Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance Myography

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Skulpt, Inc.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Skulpt, Inc.
ClinicalTrials.gov Identifier:
NCT01803386
First received: February 28, 2013
Last updated: March 1, 2013
Last verified: March 2013
  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.


Condition Intervention
Amyotrophic Lateral Sclerosis (ALS)
Device: EIM Measurements

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance Myography

Resource links provided by NLM:


Further study details as provided by Skulpt, Inc.:

Primary Outcome Measures:
  • Muscle health as captured by EIM measurements [ Time Frame: One time visit - Day 1 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: Electrical Impedance Myography Measurements

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.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

ALS Patients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803386

Contacts
Contact: Laura Freedman, MSN 888.382.8824 ext 108 musclestudy@cmdevices.com
Contact: Jose Bohorquez, PhD 888.382.8824 ext 100 musclestudy@cmdevices.com

Locations
United States, Massachusetts
Convergence Medical Devices Recruiting
Boston, Massachusetts, United States, 02210
Contact: Laura Freedman, MSN    888-382-8824 ext 108    musclestudy@cmdevices.com   
Sponsors and Collaborators
Skulpt, Inc.
Investigators
Principal Investigator: Erik Ensrud, MD VA Boston Healthcare System
  More Information

Additional Information:
No publications provided

Responsible Party: Skulpt, Inc.
ClinicalTrials.gov Identifier: NCT01803386     History of Changes
Other Study ID Numbers: EIM-002-2011-4, 2R44NS070385-02A1
Study First Received: February 28, 2013
Last Updated: March 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Skulpt, Inc.:
ALS
EIM

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Neuromuscular Diseases
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014