An observational study in Amyotrophic Lateral Sclerosis, sponsored by Beth Israel Deaconess Medical Center. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Beth Israel Deaconess Medical Center · Observational
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.
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. Given ALS's uniquely devastating nature, the fact that it is considered an "orphan disease", and uncertainties about its complex pathogenesis, many pharmaceutical companies continue to seek new therapeutic approaches. In fact, despite a relatively poor track record of success, there are a plethora of new studies starting up or planned in the near future. 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 (i.e. not influenced by patient or evaluator mood or engagement), require minimal training, be easily standardized, and be cost-efficient. Moreover, ideally, such measures, also called biomarkers, could also be used flexibly for improving individual patient care and could be applied effectively at home. Most ALS studies over the past two decades have relied on the ALS functional rating scale-revised (ALSFRS-R). Yet, it is relatively insensitive to change, altering, on average, less than 1 point per month, and requiring a large sample size to detect a drug effect, as demonstrated by several recent trials that have used it. 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 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.
Aim 1: To evaluate the sensitivity of EIM 50 kHz phase values to ALS progression, as measured by the Myolex mScan device, such that it may be able to serve as a monitoring, prognostic, or pharmacodynamic biomarker in future studies of ALS.
Aim 2: To evaluate the potential for additional at-home assessments to improve sensitivity to change/deterioration in ALS and to assess general acceptability to patients/caregivers of doing these measurements at home.
Aim 3: To utilize the full set of multifrequency parameters to assess disease progression overtime via the application of machine learning analytics to increase the power of EIM as an ALS biomarker.
981 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 283 are open to participants now.
This study's planned enrollment of 80 is below the median of 106 across 265 observational studies indexed under Amyotrophic Lateral Sclerosis.
Browse Amyotrophic Lateral Sclerosis studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with ALS
Exclusion Criteria:
Patients diagnosed with ALS
Device: Electrical Impedance Myography
EIM is an impedance-based technology in which an imperceptible, high-, multi-frequency (e.g., 1 kHz to 10 MHz) electrical current is applied across two electrodes; the resulting voltage signals are measured across two sense electrodes
Also known as: Myolex mScan
EIM phase change over time
Mean and standard deviation in rate of change in EIM phase values compared to mean and standard deviation in rate of change in ALSFRS-R over 8 months
Time frame: 8 months
Plan to share: Yes — All de-identified data will be shared publicly through existing websites (such as the Pooled Resource Open-Access ALS Clinical Trials database). We will include relevant clinical and demographic information (all de-identified). The Digital Object Identifier (DOI) will be referenced in any publication to allow the research community easy access to the exact data used in the publication. The results of the study will also be shared via publication in open-access journals and at national and international ALS meetings (e.g., at the international ALS Motor Neuron Diseases meeting).
Supporting information: Study protocol, Sap, Icf
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Amyotrophic Lateral Sclerosis→
Beth Israel Deaconess Medical Center