An observational study in Amyotrophic Lateral Sclerosis, Motor Neuron Disease and Charcot-Marie-Tooth Disease, sponsored by Skulpt, Inc.. Completed at 6 sites in United States. Open to participants aged 35 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-11.
Sponsored by Skulpt, Inc. · Observational
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.
This is a multicenter, 9-month study evaluating the effectiveness of electrical impedance myography (EIM) as a diagnostic and disease-tracking tool. In addition, the following will be studied:
116 studies on the registry are indexed under Tooth Diseases; 14 are open to participants now.
This study's enrollment of 106 is close to the median of 106 across 33 observational studies indexed under Tooth Diseases.
Browse Tooth Diseases studies →Skulpt, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
People with ALS People diagnosed with early ALS (possible, probable, probable- laboratory supported or definite ALS according to El Escorial criteria)
Other Neurological Diseases People with a diagnosis of a disease that mimics ALS
Healthy Controls Healthy Volunteers that do not have ALS or another neurological disease that mimics ALS.
Early ALS Inclusion Criteria:
Early ALS Exclusion Criteria:
ALS Disease Mimics Inclusion Criteria:
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:
Healthy Volunteer Inclusion Criteria:
Healthy Volunteer Exclusion Criteria:
*Please note that this is not a complete listing on all eligibility criteria.*
People diagnosed with early ALS (possible, probable, probable-laboratory supported or definite ALS according to El Escorial criteria) Intervention: Electrical Impedance Myography (EIM).
Device: Electrical impedance myography (EIM)
People with a diagnosis of a disease that mimics ALS
Device: Electrical impedance myography (EIM)
Healthy Volunteers that do not have ALS or another neurological disease that mimics ALS.
Device: Electrical impedance myography (EIM)
In EIM, high-frequency alternating electrical current is applied to localized areas of muscle via surface electrodes and the consequent surface voltage patterns analyzed. EIM is very sensitive to the compositional and structural elements of muscle. Data from both human subjects and animal disease models, including ALS, spinal muscular atrophy (SMA), and Duchenne muscular dystrophy (DMD), show that EIM may be sensitive to a variety of pathological states. It is anticipated that EIM will thus likely be able to assist in quantifying the severity of the disease affecting various muscle groups as well as in measuring changes in the disease over time.
Also known as: EIM1102 device
Discrimination between Groups
Determine EIM device's ability to discriminate between ALS and "look-alike" non-fatal, motor-predominant syndromes
Time frame: Duration of the Study (9 months for Group A, one visit for Groups B and C)
Tracking Progression
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
Time frame: Duration of Study, (9 months for Group A, one visit for Groups B and C)
Correlation with Outcome Measures
Determine whether EIM progression is predictive of a combined outcome of survival and progression as measured by ALSFRS-R, HHD and VC.
Time frame: Duration of Study (9 months for Group A, one visit for Groups B and C)
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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