Epidural Spinal Cord Stimulation for Respiratory Recovery in Cervical SCI

This multicenter, single-arm exploratory IIT evaluates epidural spinal cord electrical stimulation (ESCES) in 20 adults with C1-C5 SCI and respiratory failure. Participants receive ESCES plus standard care; electrodes are implanted at C3-C5 with daily individualized stimulation. Primary outcomes: Edi peak, change of Edi peak and frequency. Secondary: tidal volume, maximal inspiratory pressure, NVE, NME, diaphragm ultrasound, cough strength, 90-day ventilator-free days, ICU stay, and survival. This is the first systematic ESCES study for SCI-related respiratory failure, aiming to provide preliminary safety/efficacy data for future RCTs.

NCT Number	NCT07722130
Lead Sponsor	Zhongda Hospital Collaborators: The First Affiliated Hospital with Nanjing Medical University, Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences
Conditions	Spinal Cord Injury Cervical, Respiratory Failure
Enrollment	20 participants
Start Date	2026-06-01
Primary Completion	2028-12-31 (estimated)
Study Completion	2029-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-23