Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study
Sponsor: PathMaker Neurosystems Inc. • ClinicalTrials.gov ID: NCT06649955
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Following completion of the ALS Early Feasibility Study of the MyoRegulator® device for treatment of ALS (NCT06165172), the CALM study will further assess the feasibility of the MyoRegulator® device to treat ALS in an expanded number of individuals with ALS. CALM will gather additional preliminary evidence of clinical safety and potential effectiveness in this patient population with a longer follow-up period and additional secondary endpoints in a single-arm study prior to commencing a larger sham-controlled pivotal trial.
Interventions
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Multi-site direct current stimulation (DCS)
(Device)
The MyoRegulator® treatment is a non-invasive intervention that suppresses motor neuron hyperexcitability and activates protein degradation pathways through the use of multi-site direct current stimulation (multi-site DCS).
Eligibility criteria
Conditions
Locations
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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