Peripheral Nerve Stimulation for Lower Limb Amputees

This trial explores whether stimulating certain nerves can improve blood flow and responsiveness in people with lower limb amputations. The aim is to develop a test that checks nerve reflexes related to circulation. Participants will either have a chronically implanted neural and muscular interface or receive peripheral nerve stimulation (PNS). It suits veterans who speak English and have either a lower limb amputation or diabetes with nerve damage in the legs.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to innovative solutions for nerve-related circulation issues.

Research shows that the treatments in this trial have been studied before and are generally well-tolerated.

For the Chronically Implanted Neural and Muscular Interface, studies have shown it is safe for humans. One study examined the stability of these implants in individuals with lower limb loss over 2–4 years, and most components remained stable. This suggests the implant is safe for long-term use.

For Peripheral Nerve Stimulation (PNS), research has found it to be safe and effective, particularly for reducing pain after amputation. Patients have reported significant pain relief, with studies showing up to 100% reduction in phantom limb pain and pain in the remaining limb. Several studies have confirmed this, with patients experiencing lasting pain relief and improved quality of life over 12 months.

Researchers are excited about these treatments for lower limb amputees because they offer a fresh approach to managing nerve signals and muscle control. Unlike traditional prosthetics, which rely on mechanical designs, the chronically implanted neural and muscular interface directly stimulates nerves and muscles, potentially offering more natural movement and sensation. Meanwhile, peripheral nerve stimulation is unique in that it can be applied to both able-bodied individuals and those with limb loss, aiming to enhance nerve communication without invasive surgery. These innovations could lead to more intuitive and responsive prosthetic control, significantly improving quality of life.

Research has shown that devices implanted in nerves and muscles, which participants in this trial may receive, can help individuals with lower limb loss regain natural movement and sensation. Studies have found that these devices improve walking balance and ease movement over uneven ground. Meanwhile, peripheral nerve stimulation (PNS), another treatment option in this trial, has evidence suggesting it can significantly reduce pain, such as phantom limb pain, after an amputation. Some studies also indicate that PNS can lessen the need for pain medications. Both treatments offer promising results for enhancing the quality of life in individuals who have lost a lower limb.¹²⁴⁶⁷