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Trial Testing Nerve Stimulation for Stroke Rehab

Device and vagus nerve position

Diagram shows position of implanted device and vagus nerve (Microtransponder Inc. and Ohio State University)

3 May 2018. A clinical trial is recruiting participants to test an implanted device that electronically stimulates a key nerve pathway for restoring use of a person’s arm after suffering a stroke. One of the sites for the late-stage trial is Ohio State University in Columbus, along with 14 other locations in the U.S. and United Kingdom.

Stroke occurs when blood flow to the brain is interrupted, cutting the oxygen needed by brain cells to function. The vast majority (85%) of strokes are caused by blood clots, while many other strokes are caused by blood vessel leakage in the brain. Nearly 800,000 people in the U.S. have a stroke each year, with paralysis and weakness in the limbs among the results. Recovery, often in rehabilitation clinics, can take months or years of continuous exercises.

The device tested in the trial, called Vivistim, is developed by Microtransponder Inc. in Austin, Texas. Vivistim is implanted under the skin near the chest wall and connects to the vagus nerve, in a key pathway that extends from the brain stem to the abdomen, connecting other major organs including the heart, esophagus, and lungs. In this case, the electronic pulses sent through the vagus nerve are designed to help reconnect circuits in the brain associated with motor functions. The mild electronic pulses are triggered by a rehabilitation specialist, who pairs the nerve stimulation with exercises performed by the patient.

“This nerve stimulation is like turning on a switch making the patient’s brain more receptive to therapy,” says rehabilitation researcher Marcie Bockbrader in a university statement. “The goal is to see if we can improve motor recovery in people who have what is, in effect, a brain pacemaker implanted in their body.” Bockbader, a professor of physical medicine and rehabilitation at Ohio State, is leading the university’s participation in the project.

The clinical trial is enrolling 120 adult participants at the 15 sites up to age 79 who suffered a stroke and at least partial loss of at least one arm. All participants receive a Vivistim device, but are randomly assigned to receive a full course of stimulation with their rehab exercises, or just a single stimulation early in their rehabilitation for comparison. After 6 weeks, participants who received only the initial stimulation will begin receiving the full use of the Vivistim device. All participants will be instructed on using the device on their own at home for 30 minutes a day, and will be evaluated quarterly for up to a year after the start of therapy.

An earlier clinical study of Vivistim tested the device with 21 participants in the U.K. While the results show little difference between the full Vivistim recipients and comparison groups after 6 weeks of treatment, the differences became more noticeable, to the point of statistical reliability, after extending the treatments for 60 days.

Stimulating the vagus nerve is attracting more attention as a way to treat a number of disorders. As reported in Science & Enterprise, FDA last year approved a vagus nerve stimulation device for treating epilepsy in children, and in March 2018, a clinical trial began testing vagus nerve stimulation to treat rheumatoid arthritis.

Bockbrader and a participant in the trial tell more about the project in the following video.

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