Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance Myography

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Convergence Medical Devices

Boston, Massachusetts, 02210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Electrical Impedance Myography Measurements

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Skulpt, Inc.

Industry

Collaborators

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

Registry information

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Mar 4, 2013
Registry last updated: Jul 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed