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EIM Via the Myolex mScan as an ALS Biomarker

Electrical Impedance Myography Via the Myolex mScan as an ALS Biomarker

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

About the study

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.

What is being tested

• Electrical Impedance Myography (device)

Sponsor: Beth Israel Deaconess Medical Center · Participants: 80 · Started: Mar 1, 2025

Contact the study team

• Giulia Cenci · Phone: 617-667-3056

Official record on ClinicalTrials.gov — NCT06491732

Locations in the U.S.

Conditions

• Amyotrophic Lateral Sclerosis

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.