Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance Myography

Skulpt

Status: Completed

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Treatments: Device: EIM Measurements

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT01803386

2R44NS070385-02A1 (U.S. NIH Grant/Contract)

EIM-002-2011-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 21 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

ALS Subjects

Description:

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.

Treatment:

Device: EIM Measurements

Healthy Subjects

Description:

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.

Treatment:

Device: EIM Measurements