Vagus nerve stimulation showed significant clinical improvements across a wide range of conditions; for instance, VNS led to significant reduction in seizure severity in epilepsy trials, significant reduction in atrial fibrillation burden (NCT02548754), and improved quality of life and heart function measures in heart failure patients (NCT03327649).
There has been exponential growth in VNS clinical trials since 2015, expanding into diverse conditions including cardiovascular diseases, with a strong shift towards non-invasive modalities.
Background: Vagus nerve stimulation (VNS) is currently approved for conditions such as drug-resistant epilepsy and stroke with promising results. In addition, it is also being investigated for many other conditions. The goal of this study is to review the scope of VNS clinical trials. Methods: We conducted a retrospective review of active and completed clinical trials using ClinicalTrials.gov, with “Vagus Nerve Stimulation” as the search term. The number of studies taking place over time was assessed using Pearson correlation coefficient. Results: An examination of ClinicalTrials.gov revealed 440 clinical trials, with 346 meeting our inclusion criteria. The number of VNS clinical trials increased annually from 2000 to 2024, demonstrating exponential growth after 2015 ( P < 0.001, R 2 = 0.924). Of these, 42.5% were completed, with published results being available for 9.8% of the completed trials. Completed trials were predominantly from the United States, spanning various conditions including a wide variety of disorders such as cardiovascular diseases ( n = 38), chronic pain disorders ( n = 31), gastrointestinal disorders ( n = 24), autoimmune disorders ( n = 23), neurodegenerative diseases ( n = 19), COVID-19 ( n = 13) and diabetes ( n = 11). Among the included trials, 86% were non-invasive with 91% of trials with results reporting improvements in symptoms. Conclusion: This increasing number of trials assessing a wide breadth of clinical disorders suggests the promising future of VNS as from the currently approved treatments. Physicians should familiarize themselves with these results and potentially upcoming indications for VNS.
Horowitz et al. (Fri,) conducted a review in Patients enrolled in 346 clinical trials assessing vagus nerve stimulation for various medical conditions including cardiovascular diseases, epilepsy/seizure disorders, pain disorders, stroke, gastrointestinal disorders, psychological disorders, migraine/headache, diabetes, COVID-19, neurodegenerative diseases, arthritis, respiratory diseases, opioid use/withdrawal, infant development, ear disorders, obesity, cancer, aging, and others (n=346). Vagus nerve stimulation (VNS) vs. Sham stimulation or standard of care in interventional trials was evaluated on Varied by condition; for example, seizure reduction, atrial fibrillation burden, heart failure functional measures, migraine frequency/intensity, stroke motor function, opioid withdrawal symptoms. Vagus nerve stimulation showed significant clinical improvements across a wide range of conditions; for instance, VNS led to significant reduction in seizure severity in epilepsy trials, significant reduction in atrial fibrillation burden (NCT02548754), and improved quality of life and heart function measures in heart failure patients (NCT03327649).