RECRUITING

EIM Via the Myolex MScan As an ALS Biomarker

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Electrical Impedance Myography Via the Myolex MScan As an ALS Biomarker

Quick Facts

Study Start:2025-03-01
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06491732

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria
  2. * Capable of providing informed consent and complying with study procedures in the investigator's opinion
  3. * Time since ALS symptom onset ≤36 months
  4. * Vital Capacity of ≥50% of predicted capacity as measured by forced vital capacity
  5. * Must have a study partner for home visits
  6. * Access to the internet for data upload
  7. * Age 18 years or older
  1. * Clinically significant unstable medical condition (other than ALS) that would affect the participant's ability to participate, according to the investigator's judgment
  2. * Patient with pure upper motor neuron disease (PLS)
  3. * Known history of unstable psychiatric disease, cognitive impairment, dementia, or active substance abuse
  4. * Significant pitting edema (2+ or more) that would interfere with EIM measures
  5. * Active cancer or history of cancer treated with chemotherapy and/or radiation
  6. * BMI \>35

Contacts and Locations

Study Contact

Giulia Cenci
CONTACT
617-667-3056
gcenci@bidmc.harvard.edu

Principal Investigator

Seward Rutkove, MD
PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Masumeh Hatami, MD
STUDY_DIRECTOR
Beth Israel Deaconess Medical Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-01
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2025-03-01
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • Amyotrophic Lateral Sclerosis
  • Electrical Impedance Myography
  • Biomarker

Additional Relevant MeSH Terms

  • Amyotrophic Lateral Sclerosis