Vagus Nerve Stimulation for Spinal Cord Injury

(PIVOTS-Rehab Trial)

This trial explores a treatment called transcutaneous auricular vagus nerve stimulation (taVNS) to determine its safety and comfort for individuals who recently experienced a spinal cord injury. The treatment involves wearing a device on the ear to gently stimulate a nerve. Researchers aim to discover if taVNS can enhance mobility when combined with usual therapy. Individuals newly undergoing inpatient rehabilitation for a spinal cord injury and receiving gait training might be suitable candidates for this trial. As a Phase 1/Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in spinal cord injury rehabilitation.

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

Previous studies have shown that transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe. Research indicates that side effects are usually mild and temporary. For instance, some participants reported slight skin irritation or a tingling sensation at the application site. Importantly, these effects were brief and not severe.

One study focused on individuals with spinal cord injuries, similar to this trial, and found comparable safety results. Participants did not experience serious issues with heart function or blood pressure changes when using the taVNS device. This suggests that the treatment is well-tolerated in humans.

Unlike the standard treatments for spinal cord injury, which often focus on physical rehabilitation and medications to manage symptoms, transauricular vagus nerve stimulation (taVNS) offers a novel approach by directly stimulating the vagus nerve through the ear. This method is non-invasive and can potentially enhance neural recovery and improve mobility outcomes. Researchers are excited about taVNS because it targets the nervous system in a unique way, potentially accelerating recovery and improving quality of life for patients with spinal cord injuries.

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) might aid recovery from spinal cord injuries. Studies have found that taVNS can enhance movement and sensation when combined with regular rehab exercises. One study suggested that this technique might assist in repairing nerve fibers, a process known as remyelination. Additionally, taVNS has been linked to improved recovery in stroke patients. This trial will investigate the effects of taVNS on mobility improvement after a spinal cord injury.¹³⁶⁷⁸