Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: Early Feasibility Study of the MyoRegulator� for Treatment of ALS
Brief Summary:
This is a single-center, single-arm, open-label study aiming to assess the safety and feasibility of the MyoRegulator� device when used to treat individuals with amyotrophic lateral sclerosis (ALS).
This study is the first use of the MyoRegulator� device to treat individuals with ALS.
The main objective of this study is to confirm that individuals with ALS can tolerate the study treatment regimen without any evidence of serious adverse events related to the use of the device.
The MyoRegulator� device is a non-significant risk (NSR) investigational non-invasive neuromodulation device that uses multi-site direct current (multi-site DCS) stimulation.
It has been used in two completed clinical trials evaluating its efficacy to treat post-stroke muscle spasticity and is currently being evaluated in a third trial in this post-stroke population.