Actively Recruiting

Age: 18Years +
All Genders
NCT06491732

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here