On December 3, 2025, ClinicalTrials.gov shared details of a clinical trial investigating the use of Transauricular Vagus Nerve Stimulation (TaVNS) for delirium treatment. Sponsored by Stony Brook University, this study is actively recruiting participants and aims to evaluate the efficacy of TaVNS in managing the symptoms of delirium. The study’s focus on a device-driven intervention underscores the growing interest in non-invasive approaches to address complex neurological conditions.
What is TaVNS?
Transauricular Vagus Nerve Stimulation (TaVNS) is a non-invasive medical device-based intervention targeting the vagus nerve through the ear. Research suggests stimulating the vagus nerve has potential therapeutic effects on the autonomic nervous system, immunity, and even on neurocognitive functions. For delirium, which often presents as acute brain dysfunction, TaVNS could offer a novel pathway for symptom management.
Why is delirium a priority?
Delirium impacts millions annually, especially in hospitalized or critically ill patients. It can lead to longer hospital stays, increased morbidity, and worsened long-term cognitive outcomes. Current pharmacological options are limited and often come with significant side effects, leading researchers and clinicians to explore alternative, device-driven therapies like TaVNS.
Who can participate?
According to the trial record, Stony Brook University is recruiting for its TaVNS delirium study. Individuals experiencing delirium or at risk of developing it during hospitalization may qualify. Details regarding specific inclusion and exclusion criteria, such as comorbidities or age limits, can be accessed directly here. Clinical and regulatory teams monitoring device advancements should review the trial’s enrollment updates for potential insights into patient segmentation and device applications.
FAQ
1. How does TaVNS differ from other vagus nerve stimulation methods?
TaVNS is non-invasive and works through electrode placement on the auricular branch of the vagus nerve, unlike traditional methods requiring surgical implant devices.
2. Are there risks associated with TaVNS?
As a non-invasive device, risks are lower than surgical options, but mild side effects like irritation or discomfort at electrode sites may occur.
3. When will findings from this study be available?
The timeline for results will depend on participant enrollment and study duration. Typically, analysis may follow several years of data collection.
Conclusion
Transauricular Vagus Nerve Stimulation represents an innovative approach to addressing delirium using medical devices. Stony Brook University’s active recruitment marks a step forward in researching non-invasive and effective treatments for an often-overlooked condition. Clinical and regulatory professionals should monitor developments for implications on device-use approval, performance claims, and safety data.
Disclaimer
This blog post is provided for informational purposes and should not be considered legal or clinical advice. Always refer to original research or guidance from regulatory authorities for decision-making.
Study Information Link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07258082?term=medical+device