Clinical Trial

Epidural Spinal Cord Stimulation for Respiratory Recovery in Brain Injury

Study acronym: BREATH
Not Yet Recruiting
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Summary
Patients with severe brain injury may develop impaired respiratory drive, diaphragm dysfunction, prolonged mechanical ventilation, and difficulty recovering spontaneous breathing. Epidural spinal cord stimulation may activate preserved spinal respiratory circuits and improve respiratory muscle activity. This prospective, single-center, non-randomized, single-arm exploratory study will enroll 10 patients with stroke or traumatic brain injury who have impaired consciousness and require invasive mechanical ventilation. Participants will undergo epidural spinal cord stimulation in addition to standard clinical care. Diaphragmatic electrical activity, respiratory function, diaphragm ultrasound findings, diaphragm electromyography, duration of mechanical ventilation, pulmonary infection, length of stay, mortality, safety events, and 6-month neurological outcome will be assessed. The study aims to evaluate the safety and preliminary efficacy of epidural spinal cord stimulation for improving respiratory function after brain injury.
Trial Details
NCT Number NCT07766681
Lead Sponsor Zhongda Hospital
Collaborators: The 904th Hospital of the People's Liberation Army of China, Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Chinese PLA General Hospital
Conditions Brain Injuries, Respiratory Failure
Enrollment 10 participants
Start Date 2026-08-05
Primary Completion 2028-02-28 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-14