Clinical Trials
Ongoing clinical trials
Feasibility Study of the MyoRegulator® Device to Treat ALS
PathMaker Neurosystems is the sponsor of the Feasibility Study of the MyoRegulator® Device to Treat ALS, a US single-site feasibility study funded by Muscular Dystrophy Association (MDA) that is evaluating treatment using the MyoRegulator® device for motor neuron hyperexcitability suppression in people with amyotrophic lateral sclerosis (ALS). Those interested in potential participation in this ALS trial can contact the clinical investigators at the below link:
RECOVER Trial in Post-stroke Upper-Limb Spasticity
PathMaker Neurosystems is the sponsor of the RECOVER trial, a US multi-center pivotal trial funded by NIH that is evaluating treatment using the MyoRegulator® device in people with post-stroke upper-limb spasticity. The purpose of this study is to determine whether the treatment provided by the MyoRegulator® device for motor neuron hyperexcitability suppression can reduce chronic upper-limb spasticity following stroke. Those interested in potential participation in this stroke trial can contact the clinical investigators at the below link:
Completed clinical trials
SPAST Trial in Post-stroke Lower-Limb Spasticity
The SPAST trial is the European pivotal trial that evaluated treatment using the MyoRegulator® device in people with post-stroke lower-limb spasticity. The SPAST trial was sponsored by France’s INSERM (Institut National de la Santé Et de la Recherche Médicale), and was conducted at the Paris Brain Institute (ICM). The purpose of this study was to evaluate the performance and safety of the treatment provided by the MyoRegulator® device for motor neuron hyperexcitability suppression in reducing chronic lower-limb spasticity following stroke. Results of this successful clinical trial are being published in a forthcoming paper.
Effect of Treatment with the MyoRegulator® Device in Patients with Severe Hand Spasticity after Stroke
A US single-site clinical study was conducted to evaluate treatment using the MyoRegulator® device in people with post-stroke upper-limb spasticity. The purpose of this study was to evaluate whether treatment provided by the MyoRegulator® device for motor neuron hyperexcitability suppression could significantly reduce spasticity of the wrist and hand following stroke. Results of this successful clinical trial have been published.