BreEStim for Spinal Cord Injury Pain Management

This trial tests a new treatment called Breathing-controlled electrical stimulation (BreEStim) to manage pain after a spinal cord injury. The goal is to evaluate how well different versions of BreEStim reduce neuropathic pain, which results from nerve damage. The trial compares two treatments: one using multiple pulses and another using single pulses of electrical stimulation. It seeks participants who have had a spinal cord injury for over a year, experience ongoing nerve pain, and are stable on their current pain medications.

As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could lead to new pain management strategies.

Research has shown that BreEStim, a type of electrical stimulation controlled by breathing, is generally safe for managing pain after a spinal cord injury. Studies have found this method to be an effective non-drug treatment for chronic neuropathic pain, which arises from nerve damage.

Specifically, multiple-pulse BreEStim has been tested and proven to be an effective alternative to medication for pain relief in spinal cord injury patients. These studies reported no major safety concerns or long-term problems, indicating it is well-tolerated.

For single-pulse BreEStim, similar safety results have been observed. This treatment also uses electrical stimulation and has been shown in studies to be safe and effective for managing chronic pain.

Researchers are excited about BreEStim treatments for spinal cord injury pain management because they offer a novel approach compared to traditional options like medications, physical therapy, or invasive procedures. BreEStim, short for "Breathing-controlled Electrical Stimulation," uses electrical impulses that are synchronized with the patient’s breathing, potentially enhancing pain relief through non-invasive means. The trial is exploring two variations: multiple-pulse and single-pulse treatments. This non-invasive method could provide a safer alternative with fewer side effects, and the unique synchronization with breathing might lead to more effective pain management.

Research has shown that spinal cord stimulation (SCS) can help manage pain after spinal cord injuries. Studies have found that many patients experience significant pain relief, with some reporting a 50-75% reduction in pain. Specifically, BreEStim treatments, which use breathing-controlled electrical stimulation, have shown promise in reducing nerve pain. One study found that BreEStim led to a greater decrease in pain scores compared to other methods. This trial examines both multiple-pulse and single-pulse versions of BreEStim for their potential benefits. Participants will receive either the multiple-pulse BreEStim treatment followed by the single-pulse treatment, or vice versa, to evaluate the effectiveness of each approach.⁶⁷⁸⁹¹⁰