Status:
COMPLETED
Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance Myography
Lead Sponsor:
Skulpt, Inc.
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Amyotrophic Lateral Sclerosis (ALS)
Eligibility:
All Genders
21-85 years
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.
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...
Eligibility Criteria
Inclusion
- Diagnosis of probable or definite ALS by the El Escorial Criteria
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01803386
Start Date
January 1 2013
End Date
March 1 2015
Last Update
July 22 2015
Active Locations (1)
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1
Convergence Medical Devices
Boston, Massachusetts, United States, 02210