Electrical Impedance Myography Via the Myolex mScan as an ALS Biomarker

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Contact Information
Primary
Giulia Cenci
gcenci@bidmc.harvard.edu
617-667-3056
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 80
Treatments
Amyotrophic Lateral Sclerosis
Patients diagnosed with ALS
Sponsors
Collaborators: United States Department of Defense
Leads: Beth Israel Deaconess Medical Center

This content was sourced from clinicaltrials.gov