Complete Restoration of Respiratory Muscle Function in Three Subjects with Spinal Cord Injury Pilot Interventional Clinical Trial

Objectives To assess the safety and efficacy of complete restoration of respiratory muscle function in subjects with Spinal Cord Injury (SCI). Methods This was an interventional study investigating three subjects maintained on a diaphragm pacing system who were implanted with the spinal cord stimulation (SCS) system to restore cough. Peak expiratory airflow and airway pressure generation were the primary physiologic outcome measures; an assessment of the degree of difficulty in raising secretions was the primary clinical outcome measure. Results Mean peak expiratory airflow and airway pressure generation during spontaneous efforts were 1.7±0.2L/s and 31±7cmH2O respectively. When SCS was applied following pacing volume associated with the subject's maximum inspiratory effort and synchronized with the subject's maximum expiratory effort, peak expiratory airflow and airway pressure generation were 9.0±1.9 and 90±6cmH2O, respectively (p

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