EIM Via the Myolex MScan As an ALS Biomarker

Description

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

Amyotrophic Lateral Sclerosis

Study Overview

Study Details

Study overview

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.

Electrical Impedance Myography Via the Myolex MScan As an ALS Biomarker

EIM Via the Myolex MScan As an ALS Biomarker

Condition
Amyotrophic Lateral Sclerosis
Intervention / Treatment

-

Contacts and Locations

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 ≥50% of predicted capacity as measured by forced vital capacity
  • * Must have a study partner for home visits
  • * Access to the internet for data upload
  • * Age 18 years or older
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Beth Israel Deaconess Medical Center,

Seward Rutkove, MD, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center

Masumeh Hatami, MD, STUDY_DIRECTOR, Beth Israel Deaconess Medical Center

Study Record Dates

2026-09-30