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NCT06491732Recruiting

EIM Via the Myolex mScan as an ALS Biomarker

Electrical Impedance Myography Via the Myolex mScan as an ALS Biomarker

Source: ClinicalTrials.gov · Last updated 22 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
80 (estimated)
First submitted
1 Jul 2024
Start date
1 Mar 2025
Primary completion date
30 May 2027
Lead sponsor
Beth Israel Deaconess Medical Center
NCT number
NCT06491732

What you commit to

  • Study type: Observational
  • Planned participants: 80
  • From 1 Mar 2025 to the primary completion date, 30 May 2027
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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
  • Active cancer or history of cancer treated with chemotherapy and/or radiation

Other

  • Significant pitting edema (2+ or more) that would interfere with EIM measures
  • BMI \>35

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Michigan
Coordinator of this site? Confirm its status
Ann ArborUnited StatesRecruiting
Beth Israel Deaconess Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Massachusetts General Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Dartmouth Hitchcock Medical Center
Coordinator of this site? Confirm its status
LebanonUnited StatesRecruiting
Barrow Neurological Institute
Coordinator of this site? Confirm its status
PhoenixUnited StatesRecruiting
Atrium Health Wake Forest Baptist Medical Center
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.