Electrical Impedance Myography Via the Myolex mScan as an ALS Biomarker
Beth Israel Deaconess Medical Center
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.
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. 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 futur…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 con…
Interventions
- DeviceElectrical 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
Locations (6)
- Barrow Neurological InstitutePhoenix, Arizona
- Massachusetts General HospitalBoston, Massachusetts
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- University of MichiganAnn Arbor, Michigan
- Dartmouth Hitchcock Medical CenterLebanon, New Hampshire
- Atrium Health Wake Forest Baptist Medical CenterWinston-Salem, North Carolina