Testing Combined Low Oxygen Breathing and Spinal Cord Stimulation to Improve Walking in Adults With Chronic Spinal Cord Injury

What this Trial Is About

Researchers are evaluating how combining brief periods of low oxygen breathing, transcutaneous spinal cord stimulation, and walking training may improve walking ability for people with chronic spinal cord injury. The study is based on previous animal and human research showing that mild low oxygen exposure, called acute intermittent hypoxia AIH, and spinal cord stimulation can each enhance neural connections and function after injury. This trial aims to test whether combining these methods with walking training offers greater recovery than either method alone. Participants will receive one of three treatments AIH before walking training with spinal cord stimulation, a sham version of AIH before walking training with spinal cord stimulation, or AIH before walking training with sham spinal cord stimulation. AIH involves eight sessions over two weeks where participants breathe low oxygen mixtures through a facemask in repeated episodes. Walking training lasts 45 minutes per session with either active or sham spinal cord stimulation, where stimulation intensity is adjusted based on individual motor thresholds. During the study, participants will be assessed on walking recovery using tests like the 10-meter walk test and 6-minute walk test over approximately 12 weeks. Other evaluations include pain severity, cognitive function, and monitoring for conditions such as hypertension and autonomic dysreflexia. The trial uses random assignment and triple masking to compare outcomes across groups. Safety and progress are monitored throughout, with participants engaged in interventions and follow-up assessments lasting about three months in total.

Combination Therapy to Improve SCI Recovery.