Vagal Nerve Stimulation for Acute Stroke Treatment Trial Fully Enrolled

A phase 2 study of noninvasive vagal nerve stimulation (nVNS) for the acute treatment of stroke has achieved full enrollment. The TR-VENUS study (NCT03733431) recruited 60 participants with ischemic stroke and 8 with hemorrhagic stroke. 

The small, portable nVNS device (gammaCore Sapphire; Electrocore, Basking Ridge, NJ) can be used soon after the onset of stroke. When placed on a over the vagus nerve at the neck, the device stimulates afferent fibers. nVNS is known to reduce pain, and preclinical studies suggest vagus nerve stimulation (VNS) may have a protective effect against ischemic brain injury. 

The primary objective of this double-blind randomized trial is to assess the safety of nVNS in acute stroke by evaluating whether nVNS treatment decreases arterial blood pressure and severe bradycardia, affects progression of neurologic deficits, or reduces death. Poststroke neurologic deficits and infarct growth will also be evaluated. 

“We are very pleased to have successfully completed enrollment of this phase 2 trial to assess the safety and feasibility of nVNS for the acute treatment of stroke,” said Ethem Murat Arsava, MD, and Mehmet Akif Topcuoglu, MD, department of neurology, Hacettepe University, Ankara, Turkey. “We are hopeful that nVNS might be a viable option to improve the treatment of acute stroke.”