PathMaker Neurosystems has reported positive results from a clinical trial evaluating its MyoRegulator device as a non-invasive treatment for upper extremity spasticity in chronic stroke patients.
Spasticity occurs in many patients who have had a stroke, cerebral palsy, multiple sclerosis, spinal cord injury, traumatic brain injury, and other neurological conditions.
The chronic condition is characterised by painful muscle contractions. It is commonly managed using pharmacological agents and injected botulinum neurotoxins.
MyoRegulator has been developed to non-invasively suppress hyperexcitable spinal neurons involved with the condition.
The device uses PathMaker’s DoubleStim technology, which allows simultaneous anodal trans-spinal direct current stimulation (tsDCS) and peripheral nerve direct current stimulation (pDCS).
PathMaker conducted the single-blind, sham-controlled, crossover clinical trial to assess the device’s ability to mitigate chronic upper extremity spasticity.
The study enrolled 20 patients suffering from upper limb hemiparesis and wrist spasticity at least six months following their initial stroke.
Participants received five consecutive 20-minute daily sham stimulation treatments followed by five consecutive 20-minute daily active stimulation treatments. These treatment periods were separated by a one-week washout period.
The order of the sham and active stimulation varied in the trial arms. Investigators monitored clinical and objective measures for spasticity and motor function at baseline, at the last session, and then weekly following the active stimulation.
Findings showed significant group mean decrease from baseline in Modified Tardieu Scale scores and muscle resistance at the wrist flexor with active treatment versus sham treatment.
Active stimulation also led to significant motor function improvement, even without further prescribed activity or training. The effect of this treatment was observed to be durable for the five-week follow-up.
PathMaker Neurosystems scientific founder Zaghloul Ahmed said: “Current pharmacological approaches to managing spasticity have, at best, short-term efficacy, are confounded by adverse effects, and are often unpleasant for the patient.
“The initial study results demonstrate the potential of a novel, non-invasive treatment to reduce spasticity and improve functional recovery in patients with upper motor neuron syndrome after stroke.”
The company signed an agreement with WeHealth by Servier in January for the exclusive distribution of MyoRegulator globally, except in the US and Japan.
WeHealth also agreed to fund the device’s clinical trials in Europe. PathMaker plans to further study MyoRegulator in a separate study in the US next year.