Electrical Nerve Block for Phantom Limb Pain

This trial tests the Altius System, an electrical nerve block device, to determine its safety and effectiveness in treating phantom limb pain after amputation. The study consists of two parts: one where the Altius delivers a therapeutic nerve block and another where it delivers a non-therapeutic signal to the nerve. It suits individuals who have had one leg amputated for at least a year and experience ongoing pain episodes lasting an hour or more. Participants should not have devices like pacemakers or other conditions that might interfere with the trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research and potentially find relief from phantom limb pain.

No, you will not have to stop taking your current medications. The trial requires that you maintain a stable drug regimen for at least 4 weeks before starting and make no changes to your medications during the 3-month primary study period.

Research has shown that the Altius System, which blocks nerve signals, may help treat pain after amputation. Studies have found that it can significantly reduce pain for many patients.

Regarding safety, several studies suggest that the treatment is generally well-tolerated. For instance, one study found that most patients using the Altius System experienced significant pain relief without serious side effects. Another study monitored patients for 12 months and found no major safety issues related to the treatment.

Researchers are excited about the Altius System because it offers a novel approach to managing phantom limb pain. Unlike traditional treatments, which often include medications like opioids or antidepressants, the Altius System uses a high-frequency bioelectric nerve block. This technique directly targets the affected nerves with electrical signals, which could provide more precise and immediate pain relief without the side effects associated with drugs. Additionally, this system is self-initiated by the patient, offering a level of autonomy and convenience not typically available in standard therapies.

Studies have shown promising results for the Altius System in treating phantom limb pain. In one study, patients reported an average pain reduction of 73% over a year, indicating long-lasting relief. Another study demonstrated a 33% pain decrease just 30 minutes after therapy began. In this trial, participants may receive the Test Treatment, where the Altius System delivers a high-frequency bioelectric nerve block to the nerve, or the Active Sham Control Treatment, which involves a non-therapeutic electrical signal. The device sends a high-frequency electrical signal to the nerve, blocking pain without causing harm. These findings highlight the potential of the Altius System to effectively manage pain for individuals who have had an amputation.¹²³⁴⁵