Epidural Spinal Cord Stimulation for Respiratory Recovery in Brain Injury

ConditionsBrain Injuries Respiratory Failure

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-74

SponsorZhongda Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 74 years. Body mass index less than 30 kg/m². Imaging-confirmed stroke or traumatic brain injury. Glasgow Coma Scale score of 3 to 8, with relatively stable vital signs. Requirement for invasive mechanical ventilation through an oral or nasal endotracheal tube or tracheostomy for at least 24 hours.

Disqualifiers

Suspected or confirmed infection at the planned electrode implantation site, severe uncontrolled systemic infection, known metal allergy relevant to the implanted device, or uncontrolled intracranial hypertension.

Trial design

Design model

Single group

Treatments tested in this trial

Epidural Electrode Implantation
Procedure/Surgery
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.

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: Epidural Spinal Cord StimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in Peak Electrical Activity of the Diaphragm From Before to After Spinal Cord Stimulation

Peak electrical activity of the diaphragm will be measured using an electrical activity of the diaphragm catheter. The change from the pre-stimulation value to the post-stimulation value will be reported in microvolts (μV).

Time frame