Using Electrical Impedance Myography to Track ALS Progression
Electrical Impedance Myography Via the Myolex mScan as an ALS Biomarker
This study is testing if a new method using Electrical Impedance Myography can help track how ALS progresses in patients to improve future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 6 sites (Phoenix, Arizona and 5 other locations) |
| Trial ID | NCT06491732 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the progression of Amyotrophic Lateral Sclerosis (ALS) using Electrical Impedance Myography (EIM) as a biomarker. The study focuses on patients diagnosed with ALS who can provide informed consent and comply with study procedures. By measuring the EIM phase value from muscles, the researchers hope to establish a convenient and objective method for tracking disease progression, which could enhance the effectiveness of future therapeutic approaches. The study emphasizes the need for tools that are easy to use, standardized, and cost-efficient, potentially allowing for home application.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 years or older with a diagnosis of sporadic or familial ALS and a symptom onset of 36 months or less.
Not a fit: Patients with pure upper motor neuron disease or significant unstable medical conditions unrelated to ALS may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable biomarker for tracking ALS progression, improving patient care and the evaluation of new therapies.
How similar studies have performed: While there have been various approaches to tracking ALS progression, the use of Electrical Impedance Myography as a biomarker is relatively novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Phoenix, Arizona and 5 other locations
- Barrow Neurological Institute — Phoenix, Arizona, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States (Recruiting)
- Atrium Health Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Seward Rutkove, MD — Beth Israel Deaconess Medical Center
- Study coordinator: Giulia Cenci
- Email: gcenci@bidmc.harvard.edu
- Phone: 617-667-3056
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.