Last week, the United States Food and Drug Administration (FDA) approved a first-of-its-kind stroke rehabilitation system. This is exciting news for rehabilitation specialists and stroke survivors. Every year, close to 800,000 individuals in the United States suffer from a stroke, which means that someone is having a stroke every 40 seconds. Individuals who survive a stroke are often faced with new daily challenges and months to years of rehabilitation to regain control of various bodily functions.
For the past few years, researchers from various organizations have worked collectively on a novel approach called the Vivistim System, which uses vagus nerve stimulation for treating moderate to severe upper extremity mobility loss. This upper limb loss is commonly seen after ischemic stroke. Dr. Christopher M. Loftus, the acting director of the FDA’s Center for Devices and Radiological Health Office of Neurological and Physical Medicine Devices, states that, “people who have lost mobility in their hands and arm due to ischemic stroke are often limited in their treatment options […]. [The] approval of the Vivistim System offers the first stroke rehabilitation using vagus nerve stimulation.”
The Vivistim System works by electrically stimulating the vagus nerve. The vagus nerve is the longest and one of the most complex cranial nerves of the body. It carries information from the brain to many organ systems of the body and is involved in a vast array of bodily functions. The Vivistim System, utilizes a small implantable pulse generator that is placed under the skin of a patient with a wire lead that wraps around the vagus nerve to send electrical signals.
In a recent clinical trial testing the device, researchers studied patients who suffered from a stroke and were then implanted with the device. The researchers found that the patients implanted with the Vivistim System, in conjunction with common stroke rehabilitation, showed clinically meaningful improvements in upper extremity motor function and quality of life scores. The Vivistim System is an important and novel drug-free rehabilitation that has the potential to improve the lives of many stroke survivors.