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
- Diseases
- ALS (motor neurone disease)
- 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
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Recruiting |
| Barrow Neurological Institute Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Atrium Health Wake Forest Baptist Medical Center Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.