Non-Invasive Interventions for Respiratory Recovery in Spinal Cord Injury

(Combinatorial Trial)

This trial tests new methods to improve breathing in people with spinal cord injuries. Researchers are using two non-surgical techniques: electrical stimulation of the spine through the skin (Transcutaneous Spinal Cord Stimulation, or tSCS) and breathing special air mixtures (Hypercapnic-Hypoxia Protocol, or HiCO₂-AIH) to enhance breathing muscle strength. By combining these methods, they aim to make breathing exercises more effective. Suitable candidates for this trial include those who have had a spinal cord injury for over a year, have some remaining nerve function, and experience reduced breathing strength. The trial could enhance respiratory health and quality of life for those affected by spinal cord injuries. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could improve breathing and overall well-being.

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 to ensure safety and compatibility with the study.

Research shows that both the Hypercapnic-Hypoxia Protocol (HiCO₂-AIH) and Transcutaneous Spinal Cord Stimulation (tSCS) treatments are generally safe for people.

For HiCO₂-AIH, studies indicate that this method can safely affect the nervous system. It involves breathing air with less oxygen and more carbon dioxide for short periods to encourage deeper breathing. No serious side effects have been reported, but researchers monitor blood pressure and heart rate during treatment.

For tSCS, research has found it safe for people with spinal cord injuries. This treatment uses small electrical pulses to stimulate the spinal cord, which can help strengthen breathing muscles. Studies have not reported serious side effects, and it is considered a safe way to improve muscle function.

Researchers are excited about these interventions for respiratory recovery in spinal cord injury because they explore innovative ways to boost breathing function. Unlike typical treatments that might focus on mechanical ventilation or medication, the Hypercapnic-Hypoxia Protocol (HiCO₂-AIH) employs controlled exposure to altered oxygen and carbon dioxide levels to stimulate respiratory muscles. In addition, Transcutaneous Spinal Cord Stimulation (tSCS) is a non-invasive technique that uses electrical currents to activate spinal networks involved in breathing. These approaches offer a fresh perspective on enhancing respiratory function without relying on invasive procedures, potentially leading to more effective and patient-friendly options for those with spinal cord injuries.

Research shows that the Hypercapnic-Hypoxia Protocol (HiCO₂-AIH) can help the brain improve breathing by using special air mixtures with less oxygen and more carbon dioxide. This method strengthens breathing muscles by enhancing the brain's control over them. Studies on Transcutaneous Spinal Cord Stimulation (tSCS) indicate it can also strengthen breathing muscles in people with spinal cord injuries. It works by sending gentle electrical signals through the skin to stimulate the spinal cord, making breathing easier. In this trial, some participants will receive a combination of HiCO₂-AIH and tSCS, while others will receive these treatments individually or as sham interventions. Combining these two treatments might enhance their benefits and assist those with chronic spinal cord injuries in breathing more effectively.¹³⁴⁶⁷