Vagus Nerve Stimulation for Stroke

(NUVISTA2 Trial)

This trial explores a new method to assist individuals who have experienced an ischemic stroke, which occurs when a blood clot blocks a large brain blood vessel. The study tests a device that stimulates the vagus nerve through the ear (Transcutaneous Auricular Vagal Nerve Stimulation) to determine if it can reduce brain injury and inflammation. Some participants will receive actual stimulation, while others will use the same device without active stimulation (Sham Transcutaneous Vagal Nerve Stimulation). Individuals who have recently had an ischemic stroke due to a large vessel blockage and have no chronic infections or recent surgeries may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in stroke recovery.

The trial does not specify if you need to stop taking your current medications. However, if you are undergoing active cancer or immunosuppressive/modulating therapy, you cannot participate in the trial.

Research has shown that using a device to gently stimulate a nerve in the ear, known as transcutaneous auricular vagal nerve stimulation (taVNS), is a well-tolerated treatment. In past studies, combining taVNS with rehabilitation proved safe for stroke patients. Participants in these studies did not report any significant side effects. Another study found that taVNS improved movement in stroke patients without any obvious side effects. Overall, current evidence suggests that taVNS is a safe option for those recovering from a stroke, with no major safety concerns reported.¹²³⁴⁵

Most treatments for stroke focus on medications that dissolve clots or reduce risk factors like high blood pressure, but the transcutaneous auricular vagal nerve stimulation (taVNS) offers a different approach. This technique stimulates the vagus nerve through the skin of the ear, potentially enhancing brain recovery after a stroke. Researchers are excited about taVNS because it uses a non-invasive method to target the nervous system directly, which might accelerate brain healing and improve outcomes without the need for drugs. This could offer a new hope for stroke patients, especially those who cannot tolerate traditional medications.

Research shows that transcutaneous auricular vagus nerve stimulation (ta-VNS), a treatment participants in this trial may receive, might aid stroke recovery. Studies have found that ta-VNS can significantly enhance movement and sensation. For instance, one study discovered that patients experienced improved muscle strength and movement with ta-VNS. Additionally, animal studies of stroke have shown that ta-VNS reduces the size of damaged brain areas. Another study noted that patients treated with ta-VNS experienced better arm function and an improved overall quality of life. These findings suggest that ta-VNS could be a promising option for aiding recovery after a stroke.¹³⁶⁷⁸