University of Oklahoma researchers over a six-month period studied the effects of London-based Parasym‘s noninvasive neurostimulation device on roughly 50 paroxysmal AFib patients — half receiving vagus nerve stimulation through the external ear’s tragus and the other half receiving sham treatment on the ear lobe. The researchers trained each participant in the sham-controlled, double-blind, randomized clinical trial to use the Parasym device, which they used for one hour every day for six months.
After six months, the Parasym device reduced atrial fibrillation burden among patients actively using it by 85% compared to those receiving sham treatment.“Our clinical trial introduces a novel self-administered, non-invasive therapy for patients newly diagnosed with atrial fibrillation. There are cases when drug therapy or surgery are not the optimal options, so this has the potential to serve as another approach for patients,” said the study’s lead author, Dr. Stavros Stavrakis of the University of Oklahoma Health Sciences Center.
“It was encouraging to see the significant reduction in AF burden and that the device was well received in terms of adherence rate. This approach opens the door to a new way of thinking about AF management and showcases that we can push boundaries to help advance patient care,” Stavrakis said in a news release.
The study excluded patients with other serious heart problems — including an LV ejection fraction of less than 40%, significant valvular disease, recent stroke or myocardial infarction, severe heart failure, recurrent vaso-vagal syncopal episodes, and unilateral or bilateral vagotomy.
Stavrakis and his colleagues want trials in a multi-center setting with larger populations. They hope to pinpoint which AFib patients would benefit the most from noninvasive neurostimulation through the ear.