MyoRegulator: A non-invasive neuromodulation device for treatment of spasticity in stroke patients

PROJECT SUMMARYABSTRACT Stroke affects overmillion patients in the U Swith an estimatedadditional cases of stroke occurring each yearOverof stroke survivors have spasticitya disorder of muscle tone that can cause striking impairments in functional movementPharmacologicalsurgical and physical treatments to manage spasticity haveat bestshort term efficacy and are confounded by side effectsIn this NINDS CREATE Device projectwe propose translational activities that will advance through multi site Phase II clinical trials and regulatory submission a recently developed neuromodulation device that non invasively treats spasticity using a novel approach that combines trans spinal direct current stimulationtsDCSwith simultaneous peripheral nerve stimulationThe implications of the current project are far reaching changes in clinical practice for treating spasticity using an entirely novel approach based on non invasive neuromodulationPathMaker Neurosystems Incis a clinical stage neuromodulation company developing a first in class treatment for treating stroke patients with spasticityOur objective for this NINDS CREATE Device project is to carry out key translational activities that will be essential for advancing this technology through multi site Phase II clinical trials and regulatory approval as a safe and efficacious new treatment for spasticityThe project consists ofSpecific AimsIn Specific Aimwe will implement a GMP compliant version of the deviceMyoRegulatorfor use in a Phase II pivotal clinical study in strokeIn Specific Aimwe will implement a compliant Quality Management SystemQMSIn Specific Aimwe will complete preparations for a Phase II clinical studyIn Specific Aimwe will complete a multi site double blind controlled human clinical studyIn Specific Aimwe will submit De Novokfor regulatory approval for MyoRegulatorThese Specific Aims will lay the essential groundwork allowing our novelNIH funded technology to move rapidly through human clinical trials and to regulatory approvalAs our company works to translate the groundbreaking academic studies that have resulted in a novel approach to the treatment of spasticityNINDS CREATE Device support will advance this breakthrough treatment towards the market and enable an entirely new treatment option for stroke patients with spasticity PROJECT NARRATIVE Spasticity is a muscle tone disorder found in patients with stroke that causes striking impairments in functional movementPharmacologicalsurgical and physical treatments to manage spasticity haveat bestshort term efficacy and are confounded by side effectsOur company has developed a novel approach to non invasively modulating spinal circuits and descending pathways using non invasive neuromodulation of the spinal cord and peripheral nervesPathMaker Neurosystems Incis a clinical stage neuromodulation company developing a first in class non invasive treatment for stroke patients with spasticityand the NINDS CREATE Device project will enable crucial translational activities needed to take this therapy through engineering and human clinical trials