Tivic Health reports finding from clinical optimization trial of ncVNS

Tivic Health (TIVC) Systems has optimized key device and treatment parameters including frequency, amplitude, electrode positioning, and duration of stimulation as a result of its collaborative study with The Feinstein Institutes for Medical Research at Northwell Health. Physiological measurements taken before, during, and after ncVNS treatment found the following: Personalizing the frequency of ncVNS stimulation to each study subject resulted in a 46% increase in heart rate variability, which was 8.9x more effective than applying the same frequency to all subjects. The optimal ncVNS frequency for each subject was found to be different between visits, indicating the importance of personalizing the stimulation parameters before each treatment. Certain placement and configurations of electrodes were found to be more effective than others, with some placements increasing heart rate variability and others markedly reduce heart rate variability. Four minutes of ncVNS stimulation was sufficient to drive a large increase in heart rate variability and was more effective than twenty minutes of stimulation. While previous studies of non-invasive VNS devices have reported mixed results for autonomic nervous system changes, Tivic’s study demonstrated that specific parameters could reproducibly impact outcomes. “What makes our findings so compelling is that they advance the field of neurostimulation by underscoring the importance of stimulation frequency personalization, laterality and placement of stimulation electrodes, and duration of treatment,” stated Jennifer Ernst, CEO of Tivic Health. “While these results were in healthy subjects, this data combined with our past studies suggest our ncVNS approach may have clinical utility in several very large patient populations including ischemic stroke, post-traumatic stress disorder, and inflammatory diseases, among others.”