scientists are the first to publish clinical trial results of an investigational, non-invasive medical device for the treatment of spasticity in patients having experienced a stroke. As published in Springer Nature’s , trans-spinal direct current stimulation and peripheral nerve direct current stimulation significantly reduced upper limb spasticity in participants who experienced a stroke.
Nearly 40 percent of stroke survivors will have their movement constrained by spasticity, a residual inability of the brain to control muscle tone. Patients experience increased muscle stiffness that inhibits movement of the hands and arms and legs. Even face and throat muscles can be affected, altering or impairing speech. Spasticity sometimes causes pain.
Financial costs for stroke survivors with spasticity are four times greater than those without it. Efforts to treat upper limb spasticity have focused on intensive, repetitive, activity-dependent learning; however, it is common to experience residual spasticity despite aggressive therapy. When spasticity continues to worsen and causes pain, the standard-of-care is botox (botulinum toxin) injection.
“Spasticity is a persistent and common inhibitor of movement in patients with chronic stroke, and it has been a great hurdle as we continue to use intensive training to assist motor recovery,” said, professor at the Feinstein Institutes and lead author of the paper. “The surprise in these clinical results were the improved motor functions that apparently occurred with the focused treatment only of spasticity. We are eager to start a trial that couples motor training and anti-spasticity treatment.”
The treatment involves passing a direct electrical current across the spinal cord with a skin surface electrode, known as trans-spinal direct current stimulation (tsDCS), and adding a peripheral direct current stimulation (pDCS) in the paralyzed upper limb. There are additional benefits to patients when tsDCS is combined with pDCS.
Dr. Volpe, along with a team that includes Johanna Chang, MS, Alexandra Paget-Blanc, BS, and Maira Saul, MD, employed this device in patients with chronic stroke and hemiparesis to test whether treatment would decrease upper limb spasticity. The trial was a single-blind cross-over design study. Twenty six participants were treated with five consecutive days of 20 minutes of active, paired tsDCS+pDCS. The participants received both active and sham stimulation conditions, but were not told the order of stimulation. The device used in the trial was PathMaker Neurosystems Inc.’s MyoRegulator®, which is a first-in-class, non-invasive device that provides simultaneous, non-invasive stimulation intended to suppress hyperexcitable spinal neurons involved with spasticity.
The results demonstrated that the active treatment condition significantly reduced upper limb spasticity for up to five weeks and these patient responders saw significant improvements in motor function.
“Dr. Volpe is a leader in robotic rehabilitative medicine, and these new findings are a significant advance in usingto improve mobility,” said , president and CEO of the Feinstein Institutes.
is a new approach to treating and diagnosing disease and injury that has emerged from the Feinstein Institutes' labs. It represents a convergence of molecular medicine, neuroscience and bioengineering. Bioelectronic medicine uses device technology to read and modulate the electrical activity within the body’s nervous system, opening new doors to real-time diagnostics and treatment options for patients.