PathMaker Neurosystems has announced initiation of its US multicentre clinical trial to evaluate MyoRegulator for the non-invasive treatment of post-stroke upper-limb spasticity. The trial is funded by a US$4.9 million Cooperative Research to Enable and Advance Translational Enterprises for Devices (CREATE Devices) grant from the National Institute of Neurological Disorders and Stroke (NINDS) and is being conducted with the Spaulding Rehabilitation Hospital in Charlestown, USA.
MyoRegulator is a first-in-class, non-invasive neuromodulation device using PathMaker’s proprietary DoubleStim technology—which delivers simultaneous stimulation at spinal and peripheral sites. According to the company, it is the first and only neuromodulation device treating muscle spasticity without the need for drugs or surgery. It has been designated by the US Food and Drug Administration (FDA) as a Breakthrough Device and has been utilised in two completed clinical studies in the USA and in Europe.
This pivotal trial is designed as a multicentre, randomised, double-blind, sham-controlled trial that will evaluate the efficacy and safety of the treatment of post-stroke lower-limb spasticity with MyoRegulator in active versus sham-treated patients, with expected enrolment of 76 subjects.
“There is a pressing need for novel therapeutic options that do not involve drugs or surgery for the treatment of spasticity,” said study site principal investigator Jorge Leon Morales-Quezada (Spaulding Rehabilitation Hospital, Charlestown, USA). “The MyoRegulator device represents potential new hope for millions of patients living with this disorder around the world. We are thrilled to be involved in this trial with PathMaker and explore bringing this technology closer to clinical practice.”