Nick Fournie, a 62-year-old resident of Illinois, experienced severe depression at 24, leading to a tumultuous journey for mental health. After trying numerous medications with little success, his sister, a nurse, recommended a little-known treatment: vagus nerve stimulation (VNS).
Approved by the U.S. Food and Drug Administration (FDA) in 2005, VNS is intended for adults with chronic or recurrent depression who have not responded to at least four antidepressant treatments. Dr. Bashar Badran, a neuroscientist at the Medical University of South Carolina, describes the vagus nerve as a crucial pathway transmitting information from the brain to various organs.
Fournie participated in a VNS study led by Dr. Charles Conway, where a small pulse generator was implanted under his collarbone to stimulate the vagus nerve, sending regular pulses to brain areas that regulate mood. Today, Fournie reports significant improvements in his quality of life, stating, "It changed my life completely. I find joy every day." His wife, Mary, emphasizes the transformative impact of VNS, crediting it as a miracle for their lives.
Despite FDA approval for VNS in 2007, Medicare and Medicaid initially refused coverage, citing insufficient evidence. However, in 2019, the Centers for Medicare and Medicaid Services (CMS) began allowing coverage for patients involved in a study sponsored by LivaNova, the device manufacturer.
A recent clinical trial, conducted from September 2019 to May 2024, involved 493 adults and demonstrated that VNS therapy improved depressive symptoms, daily functioning, and quality of life. Conway noted that the study participants had an average of 13 unsuccessful treatments and had suffered from depression for an average of 29 years.
While the primary endpoint of the study was not achieved, secondary outcomes showed significant improvements in symptoms and quality of life. Notably, 18% of patients with active VNS experienced at least a 50% reduction in symptoms, and 53% reported improved quality of life.
Experts suggest that the lack of primary endpoint success does not negate the treatment's effectiveness, as many trials often achieve secondary goals. The cumulative nature of VNS treatment may explain the observed benefits in the final months of the trial.
Despite some participants in the inactive group reporting improvements, the overall findings suggest promising potential for VNS in treating treatment-resistant depression, affecting approximately 30% of the 21 million adults with major depressive disorder in the U.S.
Future monitoring of participants will provide ongoing insights, and Conway hopes the study's results will influence broader insurance coverage for VNS therapy, currently limited due to its high cost of approximately $25,000.