Severe depression completely changed the course of Nick Fournie’s life when he was just 24 years old. Fournie had been married for two years and didn’t suspect he had any underlying mental health issues. But one day, while mowing the lawn, his perspective on life flipped from light to dark. This sudden shift marked the beginning of a long, tumultuous journey as he and his wife, Mary, struggled to find a way to restore his well-being and their happiness together.
Over the next decade, Nick worked with a psychiatrist to find a medication that would help alleviate his depression. However, none of the 10 medications he tried were effective. Instead, they caused severe side effects, which Mary described as terrible reactions. Nick, who had always been sensitive to medications, experienced what he called psychotic episodes due to the side effects. Some drugs caused him to feel paranoid and even unable to leave the house. Despite his struggles, Nick was able to continue working, but he was unable to find joy in anything. He described his life as if each day felt like two.
A New Treatment Brings Hope
Nearly 20 years ago, after exhausting all other options, Nick’s sister, who worked as a nurse, recommended he explore vagus nerve stimulation (VNS). The US Food and Drug Administration (FDA) had recently approved VNS in 2005 for treating chronic or recurrent depression in adults who had failed to respond to at least four antidepressant treatments.
The vagus nerve, a bundle of over 100,000 individual nerves, connects the brain to various organs in the body, including the heart, lungs, and intestines. It acts as a bidirectional superhighway, relaying information between the brain and body. VNS works by stimulating this nerve through a small device implanted under the collarbone, which sends electrical pulses to the nerve. These pulses then travel to areas of the brain involved in mood regulation.
Nick enrolled in a VNS trial led by Dr. Charles Conway and had the device implanted. The device delivers pulses to the vagus nerve for 30 seconds every five minutes. This regular stimulation helped regulate his mood, and Nick credits it with transforming his life. He continues to use VNS alongside two antidepressants, alternating between them as needed with his doctor’s guidance.
Nick said the treatment completely changed his outlook on life, allowing him to find joy every day. Mary agreed, saying the treatment was nothing short of a miracle for them. She emphasized that while VNS is not a magic bullet and still requires behavior modifications and coping techniques, it saved their lives and gave them hope.
Challenges in Accessibility
Despite its promise, the accessibility of Vagus Nerve Stimulation treatment has been a challenge. Although the FDA approved the therapy for treatment-resistant depression, the Centers for Medicare and Medicaid Services (CMS) declined to cover it in 2007, citing insufficient evidence. This decision influenced private insurers, many of whom also chose not to cover the therapy.
Subsequent studies have provided additional support for Vagus Nerve Stimulation , leading CMS to reconsider its position in 2019. The agency decided to issue coverage with evidence development, which made VNS accessible to patients participating in FDA-approved clinical trials.
A yearlong trial conducted between 2019 and 2024 across 84 sites in the United States has provided new evidence of VNS’s effectiveness. The study included 493 adults with treatment-resistant depression, with an average age of 53. These participants had experienced an average of 29 years of depression and had failed 13 previous treatments. Many were unable to work, and nearly 40% had previously attempted suicide.
The trial found that VNS therapy led to improvements in depressive symptoms, quality of life, and daily functioning. About 18% of participants receiving active VNS experienced a significant improvement in symptoms, and 53% reported progress in quality of life.
Vagus Nerve Stimulation Limitations and Future Directions
While the study met its secondary goals, such as improvements in quality of life and depressive symptoms, it did not meet its primary goal of showing a significant difference in symptom reduction between active and inactive VNS groups. Experts noted that the severity of depression among participants likely limited the response rate.
Despite this, researchers remain optimistic about VNS’s potential, especially for patients with less severe depression. The treatment has also been shown to promote the release of key brain chemicals like serotonin and norepinephrine, which help regulate mood and are often low in people with depression. Additionally, VNS may reduce inflammation and promote brain adaptability by encouraging the formation of new neural connections.
The trial participants continue to be monitored, and researchers hope that the findings will lead to broader accessibility for VNS therapy in the future. Dr. Conway has expressed his intention to work with CMS to expand insurance coverage for the treatment.
However, the therapy remains costly, with an estimated price tag of $25,000, and is still not covered by most insurers. Patients interested in exploring Vagus Nerve Stimulation are encouraged to consult with their doctors and check if clinical trials are an option.
A Step Forward for Treatment-Resistant Depression
With around 30% of the 21 million adults diagnosed with major depressive disorder in the United States experiencing treatment-resistant depression, VNS offers a promising alternative for those who have not found relief through traditional methods. While it is not a perfect solution, the therapy provides hope for improved quality of life and emotional well-being for patients like Nick, who thought their struggles might never end.
