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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44NS070385-02A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALS Subjects | 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. |
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| Healthy Subjects | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EIM Measurements | Device | EIM measurements are taken by applying saline to the skin and placing a sensor on patients' muscles that will record electrical activity. Electrical current is generated by this machine, but patients will not be able to feel it. The electrical activity recorded is returned to the machine and analyzed by a computer. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle health as captured by EIM measurements | EIM measurements will be performed with several electrode arrays at one visit per patient. The data captured from ALS and healthy subjects will be used to refine and finalize electrode array design development for the EIM system. | One time visit - Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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ALS Patients
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| Name | Affiliation | Role |
|---|---|---|
| Erik Ensrud, MD | VA Boston Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Convergence Medical Devices | Boston | Massachusetts | 02210 | United States |
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| Label | URL |
|---|---|
| Convergence Medical Devices Website | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 16, 2018 | |
| Reset | Jun 14, 2018 | |
| Release | May 8, 2020 | |
| Reset | May 22, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 16, 2018 | Jun 14, 2018 | |||
| May 8, 2020 |
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| May 22, 2020 |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |