EIM Via the Myolex mScan as an ALS Biomarker

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeth Israel Deaconess Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients diagnosed with ALS

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Electrical Impedance Myography

    Device

    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

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Amyotrophic Lateral Sclerosis1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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Beth Israel Deaconess Medical Center

Lead sponsor

United States Department of Defense

Collaborator