US-based clinical-stage neurotechnology company PathMaker Neurosystems has commenced the first human clinical trial in collaboration with Northwell Health and the Feinstein Institute for Medical Research to assess the safety and efficacy of MyoRegulator to treat spasticity.
Spasticity is a common occurrence in many patients who have suffered from a stroke or who have cerebral palsy, multiple sclerosis, spinal cord injury, brain injury and other neurological conditions.
The disabling condition is characterised by tight or stiff muscles and an inability to control those muscles.
More than 15 million patients worldwide say they are being affected by spasticity.
Feinstein Institute Laboratory of Biomedical Science investigator and lead investigator of the study Bruce Volpe said: "I see patients who can no longer open doors or feed themselves as a result of suffering from spasticity.
"It is my hope that at the conclusion of this trial, we will see that MyoRegulator is a safe and effective treatment option."
Approved by Institutional Review Board (IRB), the MyoRegulator clinical trials have also been confirmed as a non-significant risk (NSR) device study by the US Food and Drug Administration (FDA).
An NSR designation allows the pursuit of a clinical trial without an approval of Investigational Device Exemption (IDE).
MyoRegulator is a non-invasive device used to treat spasticity afflicted patients leveraging on Pathmaker’s proprietary DoubleStim technology for multi-site neurostimulation.
Patients with spasticity have damaged neural pathways that create hyperexcitable spinal circuits and can be addressed by the DoubleStim technology which has been shown in published animal studies to be able to suppress the hyperexcitability, thereby leading to reduced muscle spasticity.
However, MyoRegulator is an investigational device and is limited by the US law for investigational use only.