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Epidural Spinal Cord Stimulation for Respiratory Recovery in Brain Injury
Sponsor: Zhongda Hospital
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.
Official title: An Exploratory Clinical Trial of Epidural Spinal Cord Stimulation for Respiratory Recovery in Patients With Brain Injury
Key Details
Gender
All
Age Range
18 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2026-08-05
Completion Date
2028-12-31
Last Updated
2026-08-14
Healthy Volunteers
No
Conditions
Interventions
Epidural Electrode Implantation
Participants will undergo surgical implantation of an epidural spinal cord stimulation electrode under anesthesia. The electrode will be positioned at the spinal level specified in the final surgical protocol and connected to a stimulation system.
Locations (3)
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China
The 904th Hospital of the Joint Logistic Support Force of the Chinese People's Liberation Army
Suzhu, Jiangsu, China