Study Purpose:
This trial is studying Electrical Impedance Myography (EIM) for measuring muscle health. The trial is studying people with Amyotrophic Lateral Sclerosis (ALS), other neuromuscular diseases, and healthy volunteers to see if the EIM device can measure disease in muscle tissue.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis , Motor Neuron Disease , Charcot-Marie-Tooth Disease , Multiple Sclerosis
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Jeremy Shefner, MD, PhD, State University of New York - Upstate Medical University
Clinicaltrials.gov ID:
Neals Affiliated?
Yes
Coordinating Center Contact Information
Mass General Hospital
165 Cambridge Street
Boston, Massachusetts, 02114 United States
Full Study Summary:
1. Determine EIM device's ability to discriminate between ALS and "look-alike" non-fatal, motor-predominant syndromes;
2. Track EIM progression over time and determine the best summary EIM measure that could serve as an endpoint in future clinical trials and individual patient care; and,
3. Determine whether EIM progression is predictive of a combined outcome of survival and progression as measured by ALS Functional Rating Scale, Revised (ALSFRS-R), Hand-held Dynamometry (HHD) and Vital Capacity (VC) measures.
Study Sponsor:
Skulpt, Inc.
Participant Duration:
9 months
Estimated Enrollment:
106
Estimated Study Start Date:
10 / 31 / 2013
Estimated Study Completion Date:
03 / 01 / 2016
Posting Last Modified Date:
05 / 11 / 2016
Date Study Added to neals.org:
12 / 13 / 2013
Minimum Age:
35 Years
Maximum Age:
80 Years
Early ALS Inclusion Criteria:- Sporadic or familial ALS (as defined by revised El Escorial criteria)
- Onset of weakness or spasticity due to ALS ≤ 36 months prior to the Screening/Baseline Visit.
- Slow vital capacity (SVC) ≥60% of predicted for gender, height, and age
Early ALS Exclusion Criteria:
- The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, or a history of active substance abuse within the prior year.
ALS Disease Mimics Inclusion Criteria:
- Diagnosis of one of the following:
a. Pure Lower Motor Neuron Disease (LMND) mimics: i. Multi-focal motor neuropathy ii. Autoimmune motor neuropathy iii. Cervical or lumbosacral radiculopathies with weakness involving more than one extremity or more than a single myotome if restricted to one extremity.
iv. Multiple peripheral mononeuropathies with clinical weakness v. Charcot-Marie-Tooth Disease vi. Any condition that produces generalized or localized weakness without concomitant sensory symptoms, including myasthenia gravis or myopathy, that the evaluating physician deems mimics ALS.
b. Pure Upper Motor Neuron Disease (UMND) mimics: i. Cervical myelopathy ii. Multiple sclerosis iii. Hereditary spastic paraparesis
ALS Disease Mimics Exclusion Criteria:
- Diagnosis of possible, probable, probable-laboratory supported, or definite ALS
- Presence of positive family history of ALS.
- The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, or a history of active substance abuse within the prior year.
Healthy Volunteer Inclusion Criteria:
- Absence of a known neurological disorder.
Healthy Volunteer Exclusion Criteria:
- History of ALS, myopathy, neuropathy, ALS mimic disorder or other neurodegenerative disease.
- Presence of positive family history of ALS.
- The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, or a history of active substance abuse within the prior year.
*Please note that this is not a complete listing on all eligibility criteria.*
St. Joseph's Hospital & Medical Center
Phoenix, Arizona
85013
United States
University of Miami Miller School of Medicine
Miami, Florida
33136
United States
Massachusetts General Hospital
Boston, Massachusetts
02114
United States
Skulpt, Inc
Boston, Massachusetts
02210
United States
SUNY Upstate Medical University
Syracuse, New York
13210
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina
27157
United States