Actively Recruiting
EIM Via the Myolex mScan as an ALS Biomarker
Led by Beth Israel Deaconess Medical Center · Updated on 2026-04-22
80
Participants Needed
6
Research Sites
117 weeks
Total Duration
On this page
Sponsors
B
Beth Israel Deaconess Medical Center
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
EIM Via the Myolex mScan as an ALS Biomarker
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria
- Able to provide informed consent and comply with study procedures
- ALS symptom onset 36 months or less ago
- Vital Capacity of 40% or more of predicted capacity measured by forced or slow vital capacity
- Must have a study partner for home visits
- Access to the internet for data upload
- Age 18 years or older
You will not qualify if you...
- Clinically significant unstable medical condition (other than ALS) affecting participation
- Patient with pure upper motor neuron disease (PLS)
- Known history of unstable psychiatric disease, cognitive impairment, dementia, or active substance abuse
- Significant pitting edema (2+ or more) interfering with EIM measures
- Active cancer or history of cancer treated with chemotherapy and/or radiation
- Body mass index (BMI) greater than 35
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02110
Actively Recruiting
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
5
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
Actively Recruiting
6
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
G
Giulia Cenci
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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