EIM Via the Myolex mScan as an ALS Biomarker
NCT06491732 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80
Last updated 2026-04-22
Summary
Amyotrophic lateral sclerosis (ALS) has been traditionally considered incurable and untreatable. But starting in the 1990s with the introduction of Riluzole, therapies are being discovered and ultimately approved for slowing disease progression. Many pharmaceutical companies continue to seek new therapeutic approaches. One critical aspect of all clinical trials is the need track to progression sensitively to identify the impact of therapy. Tools to track ALS progression must be convenient, objective, require minimal training, be easily standardized, cost-efficient, and have the potential to be applied effectively at home. There has been a push to identify accurate, objective biomarkers of ALS progression. In this study, the investigators propose to use Electrical impedance myography (EIM) to evaluate the progression of the disease. Work has shown that the EIM 50 kilohertz (kHz) phase value from one or more muscles, followed sequentially, can serve as an effective overall biomarker for assessing the rate of ALS progression for a single person.
Conditions
Interventions
- DEVICE
-
Electrical Impedance Myography
EIM is an impedance-based technology in which an imperceptible, high-, multi-frequency (e.g., 1 kHz to 10 MHz) electrical current is applied across two electrodes; the resulting voltage signals are measured across two sense electrodes
Sponsors & Collaborators
-
United States Department of Defense
collaborator FED -
Beth Israel Deaconess Medical Center
lead OTHER
Principal Investigators
-
Seward Rutkove, MD · Beth Israel Deaconess Medical Center
-
Masumeh Hatami, MD · Beth Israel Deaconess Medical Center
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-01
- Primary Completion
- 2027-05-30
- Completion
- 2027-05-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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