Nerve-stimulation device can help stroke patients regain motor function
A first-of-its-kind nerve stimulation treatment for people who have problems moving their arms after a stroke has been approved by the U.S. Food and Drug Administration.
“People who have lost mobility in their hands and arms due to ischemic stroke are often limited in their treatment options for regaining motor function,” said Dr. Christopher Loftus, acting director of the FDA’S Center for Devices and Radiological Health’s Office of Neurological and Physical Medicine Devices. An ischemic stroke is caused by blocked blood flow to the brain.
“(The) approval of the Vivistim Paired VNS System offers the first stroke rehabilitation option using vagus nerve stimulation (VNS),” Loftus said in a release. “Used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke.”
The Vivistim System is a prescription therapy for ischemic stroke patients who have moderate to severe difficulty moving their arms and hands. The system electrically stimulates the vagus nerve, which runs from the brain to the abdomen.
An implantable generator that produces a mild electrical pulse is implanted just under the skin in the chest of the patient. A wire that’s attached to the generator is also implanted under the skin and sends pulses to electrodes that are placed on the left side of the neck, where the vagus nerve is located, the FDA explained.
The FDA approval was based on a clinical trial of 108 stroke patients in the U.S. and United Kingdom. Patients were asked to complete physical therapy exercises, but only the treatment group received an appropriate level of vagus nerve stimulation. A “control group” received a low level of stimulation.
After three months of follow-up, the trial found that stroke survivors treated appropriately with the system gained greater increases in the use of their arms and hands.
Side effects of using the system included difficulty speaking, bruising, falling, hoarseness, low mood, fracture, rash, throat irritation and urinary tract infection, according to the FDA.