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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People with ALS | People diagnosed with early ALS (possible, probable, probable-laboratory supported or definite ALS according to El Escorial criteria) Intervention: Electrical Impedance Myography (EIM). |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical impedance myography (EIM) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Discrimination between Groups | Determine EIM device's ability to discriminate between ALS and "look-alike" non-fatal, motor-predominant syndromes | Duration of the Study (9 months for Group A, one visit for Groups B and C) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Duration of Study, (9 months for Group A, one visit for Groups B and C) |
| Correlation with Outcome Measures |
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Early ALS Inclusion Criteria:
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:
Healthy Volunteer Inclusion Criteria:
- Absence of a known neurological disorder.
Healthy Volunteer Exclusion Criteria:
*Please note that this is not a complete listing on all eligibility criteria.*
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy Shefner, MD, PhD | State University of New York - Upstate Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital & Medical Center | Phoenix | Arizona | 85013 | United States | ||
| University of Miami Miller School of Medicine |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| D016472 | Motor Neuron Disease |
| D002607 | Charcot-Marie-Tooth Disease |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
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Determine whether EIM progression is predictive of a combined outcome of survival and progression as measured by ALSFRS-R, HHD and VC. |
| Duration of Study (9 months for Group A, one visit for Groups B and C) |
| 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 |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D015417 | Hereditary Sensory and Motor Neuropathy |
| D009421 | Nervous System Malformations |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |