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Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance Myography

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ClinicalTrials.gov Identifier: NCT01803386
Recruitment Status : Completed
First Posted : March 4, 2013
Last Update Posted : July 22, 2015
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Skulpt, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis (ALS) Device: EIM 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.
Study Design
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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance Myography
Study Start Date : January 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

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Groups and Cohorts
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803386


Locations
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United States, Massachusetts
Convergence Medical Devices
Boston, Massachusetts, United States, 02210
Sponsors and Collaborators
Skulpt, Inc.
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Erik Ensrud, MD VA Boston Healthcare System
More Information
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Additional Information:

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Responsible Party: Skulpt, Inc.
ClinicalTrials.gov Identifier: NCT01803386    
Other Study ID Numbers: EIM-002-2011-4
2R44NS070385-02A1 ( U.S. NIH Grant/Contract )
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: July 2015
Keywords provided by Skulpt, Inc.:
ALS
EIM
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neuromuscular Diseases
Neurodegenerative Diseases
Nervous System Diseases
 Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases