Vagus Nerve Stimulation for Aortic Dissection

(taVNS for TBAD Trial)

This trial explores a new method to assist individuals with uncomplicated Type B aortic dissections, a serious condition where the inner layer of the aorta tears. The trial uses a device that stimulates the vagus nerve in the ear, known as transcutaneous auricular vagus nerve stimulation. The goal is to determine if this treatment can help control heart rate and blood pressure while reducing inflammation. Participants will receive either actual stimulation or a placebo, meaning they will wear the device without activation. Suitable candidates for this trial have experienced a recent uncomplicated Type B aortic dissection and can join within 24 hours of diagnosis. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could lead to new treatment options.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe for people. Studies indicate that taVNS, a non-invasive technique, influences the body's nervous system without causing serious side effects. Patients have used it safely without experiencing issues like a slow heart rate or heart rhythm problems.

Researchers are excited about transcutaneous auricular vagus nerve stimulation for aortic dissection because it offers a non-invasive method to potentially manage this serious condition. Unlike traditional treatments that might involve medication or surgery, this approach uses a 3D-printed earpiece for nerve stimulation, which could reduce risks and recovery times associated with more invasive procedures. The technique targets the vagus nerve, aiming to improve outcomes by possibly stabilizing heart rate and blood pressure through nerve signaling, offering a novel mechanism of action that differs from existing therapies.

This trial will evaluate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) for aortic dissection. Studies have shown that taVNS can influence the body's nervous system, potentially helping to manage heart rate, blood pressure, and inflammation. Research indicates that taVNS is safe and does not cause harmful effects on the heart, such as a slow heart rate or irregular heart rhythms. This non-invasive treatment has been studied for various health issues and shows promise in controlling inflammation and regulating heart functions. Although direct data on its use for aortic dissection is limited, its mechanism suggests it could help patients by calming stress responses and reducing inflammation. Participants in this trial will be divided into a treatment cohort receiving active taVNS and a non-treatment cohort receiving a placebo.¹⁶⁷⁸⁹