Trials / Completed
CompletedNCT02011204
Study of Electrical Impedance Myography (EIM) in ALS
Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 106 (actual)
- Sponsor
- Skulpt, Inc. · Industry
- Sex
- All
- Age
- 35 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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: 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2016-03-01
- Completion
- 2016-03-01
- First posted
- 2013-12-13
- Last updated
- 2016-05-11
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02011204. Inclusion in this directory is not an endorsement.