TENS of Auricular Vagal Nerve for Radiation Necrosis

This trial tests a new treatment using a device that stimulates the vagus nerve through the ear to address brain swelling from radiation treatment. The goal is to determine if this treatment, known as transcutaneous auricular vagal nerve stimulation (taVNS), can reduce swelling and inflammation in patients with brain lesions from radiation therapy. Participants will join one of two groups: one receiving the actual treatment and the other a sham treatment, to compare results. This trial suits those who have undergone brain radiation and are experiencing swelling, as indicated by a recent MRI. Participants should be able to pause steroid use for a few days before starting the trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for brain swelling.

Research has shown that transcutaneous auricular vagal nerve stimulation (taVNS) uses gentle electrical currents to help manage pain. This non-invasive method does not involve surgery or needles. Studies have found that similar treatments are generally well-tolerated, with few reports of serious side effects. Most people experience only mild discomfort during treatment, if any. Small devices placed on the skin apply the gentle electrical currents. While specific safety data for taVNS is limited, it resembles other well-studied nerve stimulation treatments, which have a good safety record.¹²³⁴⁵

Unlike the standard of care for radiation necrosis, which typically involves medications like corticosteroids or hyperbaric oxygen therapy, transcutaneous auricular vagal nerve stimulation (taVNS) offers a non-invasive alternative. This technique involves stimulating the vagus nerve via the ear, which is thought to help reduce inflammation and promote healing. Researchers are excited about taVNS because it represents a novel mechanism of action compared to traditional treatments, potentially offering relief without the side effects associated with more invasive or medication-based therapies.

Research has shown that transcutaneous auricular vagal nerve stimulation (taVNS), a treatment participants in this trial may receive, might reduce inflammation and protect the brain. Studies have found that taVNS can enhance brain function and decrease the size of brain injuries in stroke models. This suggests it might also help with brain swelling caused by radiation treatment. It has effectively reduced pain and improved outcomes in various conditions, indicating its potential for treating different issues. Although direct evidence for its effect on radiation necrosis is limited, these findings suggest taVNS could be beneficial.⁶⁷⁸⁹¹⁰