EIM Via the Myolex mScan as an ALS Biomarker

Recruiting now

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID: NCT06491732
Run by: Beth Israel Deaconess Medical Center
People needed: 80
Starts: 2025-03-01
Expected to finish: 2027-05-30
Last updated by the study team: 2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or deﬁnite ALS deﬁned by revised El Escorial criteria
Capable of providing informed consent and complying with study procedures in the investigator's opinion
Time since ALS symptom onset ≤36 months
Vital Capacity of ≥40% of predicted capacity as measured by forced vital capacity 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 may not qualify if…

Clinically signiﬁcant unstable medical condition (other than ALS) that would affect the participant's ability to participate, according to the investigator's judgment
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) that would interfere with EIM measures
Active cancer or history of cancer treated with chemotherapy and/or radiation
BMI >35

Where it is running

Barrow Neurological Institute — Phoenix, Arizona, United States (enrolling)
Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
University of Michigan — Ann Arbor, Michigan, United States (enrolling)
Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
Atrium Health Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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