Relative Ischemic Lesion Growth Decreased More with nVNS for Treatment of Acute Stroke

Data presented at the American Heart Associations’ 2022 International Stroke Conference suggests safety and feasibility of noninvasive vagus nerve stimulation (nVNS)(electroCore, Rockaway, NJ) in the acute treatment of stroke.

The randomized sham-controlled study TR-VENUS (NCT03733431) had an intent-to-treat (ITT) population of 69 participants (61 ischemic stroke and 8 intracerebral hemorrhage) distributed into 3 treatment arms. Sham (n=25), standard-dose nVNS (7 stimulations over 1 hour; n=19), and high-dose nVNS (7 stimulations in hour 1 and hour 5; n=25). 

Relative infarct growth, measured by diffusion weighted imaging, in the high dose nVNS group (63.3%) was lower than in the sham group (185.8%; P=.05) compared with baseline. 

Dr. Murat Arasava, one of the primary investigators of the TR-VENUS study and professor of Neurology at the Hacettepe University in Ankara, Turkey commented, “We are pleased to have successfully completed this first trial of nVNS as a possible treatment for acute stroke and believe our data suggests that nVNS may be safe and feasible in both ischemic and hemorrhagic stroke. The efficacy signal suggested by the reduction in relative infarct growth rate in the ischemic population, which needs to be confirmed in larger studies, clearly provides the basis for additional research to further define the role for nVNS for the acute treatment of stroke.”

The first nVNS treatment was given to 97% of all participants within 6 hours of stroke onset, and all in the ITT population had all prespecified treatments per protocol.

The study data was consistent across the 3 treatment arms indicating that nVNS was able to be administered safely in this acute stroke population. The NOVIS study (NCT04881162) is a prospective randomized clinical trial with blinded outcome. Participants (n=150) with ischemic stroke are randomly allocated (1:1) to nVNS for 5 days in addition to standard treatment versus standard treatment alone. This study features a greater number of stimulations over 5 days than TR-VENUS, and advanced imaging including measurement of the penumbra.