Noninvasive Vagal Nerve Stimulation for Migraine Prevention Decreases in Migraine-Associated Disability and Improves Quality of Life

In the PREMIUM 2 study (NCT03716505), individuals with migraine treated with noninvasive vagal nerve stimulation (nVNS) had significant decreases in migraine-associated disability and improvement in quality of life. The 50% or more responder rate in those treated with nVNS was 44.9% vs 26.8% with sham stimulation (P=.048). In a predefined group of participants who were diagnosed with migraine with aura, those who used nVNS had 5.5 fewer headache days every 4 weeks compared to baseline vs 2.7 fewer headache days in those treated with sham stimulation (P=.041). 

Dr. Umer Najib, MD, FAHS, director of the West Virginia University Headache Center and an investigator in the Premium 2 study, commented “I am pleased that nVNS continues to demonstrate its ability to effectively decrease the migraine burden in patients who need preventive therapy. The strong benefit seen in patients diagnosed with aura is particularly interesting as those patients can often be particularly difficult to treat.”

In a modified intention-to-treat (mITT) analysis, participants who used nVNS had 3.1 fewer migraine days over the last 4 weeks of the 12-week double-blind study period vs the 4 weeks run-in period compared with a decrease of 2.3 migraine days in those who had sham stimulation (P=.233).

The PREMIUM 2 study was a randomized double-blind sham-controlled clinical trial of nVNS for the prevention of migraine conducted at over 30 sites. The study originally enrolled approximately 300 participants. The study was closed early because of the COVID-19 pandemic, resulting in intent to treat (ITT) and mITT groups of 228 and 113 participants, respectively.

In the study, no serious adverse effects were reported, leading to nVNS’ strong safety and tolerability profile remaining consistent.