Spinal Cord Stimulation for Diabetic Neuropathy

(MED DPN Trial)

This trial tests a new method of using spinal cord stimulation (SCS) to assist individuals with diabetic neuropathy, a condition that causes painful nerve damage in people with diabetes. The device, Medtronic Inceptiv, has approval for chronic pain, but this study examines a special setting called Differential Target Multiplexed (DTM) stimulation to determine if it can more effectively reduce pain. The trial begins with a short test phase, and if successful, progresses to a permanent device implant with follow-ups for a year. Eligible participants have diabetic neuropathy, particularly with persistent leg pain that hasn't improved with medication.

As an unphased trial, this study provides a unique opportunity to explore innovative pain relief options for diabetic neuropathy.

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

Research has shown that closed-loop spinal cord stimulation (SCS) systems, such as the Medtronic Inceptiv, are safe. The FDA has approved this device for treating chronic pain, indicating its general safety. Specifically, studies found that it can reduce pain scores by 67% after 12 months, demonstrating its effectiveness and tolerability for many patients.

Unlike the standard treatments for diabetic neuropathy, which often involve medications like gabapentin or pregabalin to manage symptoms, the Medtronic Inceptiv™ Closed-Loop DTM Spinal Cord Stimulation (SCS) offers a different approach. This treatment uses a closed-loop system that adapts to the body's electrical signals, providing personalized pain relief. It employs a unique method called ECAP-guided Differential Target Multiplexed stimulation, which is designed to optimize the delivery of electrical impulses for better outcomes. Researchers are excited about this treatment because it promises more precise and potentially more effective pain management for people with diabetic neuropathy.

Research has shown that spinal cord stimulation (SCS) can help reduce chronic pain. Specifically, studies have found that the Medtronic Inceptiv SCS system, which participants in this trial will receive, can significantly relieve pain. For instance, one study reported an average pain reduction of 67% over 12 months, with 87% of participants experiencing meaningful improvements in their condition. The Inceptiv SCS uses a method called Differential Target Multiplexed (DTM) stimulation, which adjusts the stimulation based on signals from the spinal cord. This method aims to provide more consistent pain relief for people with painful diabetic neuropathy.¹²³⁶⁷