Peripheral Nerve Stimulation for Amputees

This trial tests a new treatment called Altius Peripheral Nerve Stimulation, a device-based therapy, for individuals who have lost a leg and continue to experience severe nerve pain unrelieved by surgeries like TMR or RPNI. The trial aims to determine if this treatment can reduce pain and improve quality of life. Eligible participants should have undergone nerve-related surgeries at least 9 months ago but still suffer from significant, chronic pain. Those who have tried a lidocaine injection and experienced at least a 50% reduction in pain may be well-suited for this study. As an unphased trial, it offers a unique opportunity to explore a promising new treatment option for managing chronic nerve pain.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the study team to get a clear answer.

Research has shown that the Altius Peripheral Nerve Stimulation system is safe and effective for individuals experiencing pain after amputation. This FDA-approved device reduces pain and decreases the need for opioid painkillers. Participants in these studies reported significant improvements in their quality of life over time.

Most treatments for chronic pain in amputees, like medications or nerve surgeries, aim to manage symptoms rather than directly influence nerve activity. However, Altius Peripheral Nerve Stimulation is unique because it targets the nerves directly involved in pain transmission, offering a potentially more effective solution. Researchers are excited about this treatment because it uses a novel method to modulate nerve activity, which could provide relief where other treatments have failed. Additionally, this approach is less invasive and might offer faster pain relief compared to traditional surgical options.

Research has shown that the Altius Peripheral Nerve Stimulation system reduces long-term pain for individuals with lower-limb amputations. Participants in this trial will receive the Altius system, which studies have found to decrease pain, reduce the need for painkillers, and improve quality of life. One study demonstrated that the Altius system provided lasting pain relief and enhanced patient function after three months. Another study found these benefits persisted for at least a year. The FDA has approved the Altius system, confirming it meets safety and effectiveness standards for treating post-amputation pain.²³⁵⁶⁷