Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07766681
NA

Epidural Spinal Cord Stimulation for Respiratory Recovery in Brain Injury

Sponsor: Zhongda Hospital

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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