Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance Myography

NCT01803386 | Completed DMC

• 2 other identifiers: EIM-002-2011-42R44NS070385-02A1
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Keywords

ALS; EIM

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

EIM Measurements DEVICE

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.

Also known as: Electrical Impedance Myography Measurements

ALS Subjects; Healthy Subjects

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ALS Patients

You may qualify if:

• Diagnosis of probable or definite ALS by the El Escorial Criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Skulpt, Inc.: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Convergence Medical Devices

Boston, Massachusetts, 02210, United States

Location

Related Links

• Convergence Medical Devices Website

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Erik Ensrud, MD

  VA Boston Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: March 4, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 22, 2015

Record last verified: 2015-07

Locations

US (1)