An interventional study of Epidural spinal cord stimulation in Spinal Cord Injury Cervical and Respiratory Failure, sponsored by Zhongda Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Zhongda Hospital · Not applicable, Interventional, and Treatment
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.
This is a multicenter, prospective, single-arm, exploratory investigator-initiated trial (IIT) conducted at Zhongda Hospital, Southeast University and the First Affiliated Hospital of Nanjing Medical University. The study aims to evaluate the safety and efficacy of epidural spinal cord electrical stimulation (ESCES) in patients with spinal cord injury (SCI) complicated by respiratory failure.
A total of 20 adult patients (aged 18-75 years) with C1-C5 level SCI for at least 2 weeks and respiratory failure requiring mechanical ventilation or presenting with hypoxemia/hypercapnia will be enrolled. Participants will receive standard conventional treatment plus ESCES. Electrodes will be surgically implanted at the C3-C5 epidural space, and stimulation will be delivered daily with individualized parameter titration based on patient tolerance.
The primary outcomes are Edi peak, change of Edi peak and frequency. Secondary outcomes include tidal volume, diaphragmatic ultrasound parameters, cough strength, 90-day ventilator-free days, ICU length of stay, and survival at 90 and 180 days.
The observation period is defined as the period from enrollment until 1 month after enrollment or until successful weaning from mechanical ventilation, ICU discharge, removal of the epidural stimulation electrode, withdrawal from the study, or death, whichever occurs first.
This study is the first systematic exploration of ESCES for respiratory function recovery in SCI patients with respiratory failure, and may provide a novel therapeutic strategy for this population. The trial is expected to run for approximately 30 months. Participation is voluntary, and participants may withdraw at any time without affecting their subsequent care.
Respiratory failure defined by one or more of the following:
Exclusion Criteria:
Other: Epidural spinal cord stimulation
①Epidural electrode implantation Under general anesthesia, two epidural electrodes will be implanted through a posterior cervical approach and positioned over the dorsal epidural space at the C3-C5 spinal levels. An implantable pulse generator will be placed in the lateral chest wall. ②.Epidural Spinal Cord Stimulation ESCS will begin on postoperative day 2. Initial stimulation parameters will include: * Pulse width: 200 μs (maximum 500μs) * Frequency: initially 10 Hz, gradually increased up to 60 Hz (maximum 300 Hz) according to tolerance * Current intensity: initially 1 mA, increased in 0.5 mA increments to the maximum tolerated intensity (up to 20 mA) Stimulation will be delivered daily. Stimulation parameters will be recorded throughout the study, and settings may be adjusted to minimize discomfort. Additional supportive care will be provided as clinically indicated.
Adverse Events
Incidence of Adverse Events and Serious Adverse Events Related to Epidural Spinal Cord Stimulation; Safety will be assessed by the occurrence of adverse events (AEs) and serious adverse events (SAEs) considered possibly, probably, or definitely related to epidural electrode implantation, the stimulation device, or epidural spinal cord stimulation.
Time frame: From epidural electrode implantation through Day 30.
Diaphragmatic function
Peak electrical activity of the diaphragm (Edi peak): Peak electrical activity of the diaphragm measured using an electrical activity of the diaphragm (Edi) catheter. Values are reported in microvolts (μV). Diaphragmatic electrical activity frequency (Edi frequency): Diaphragmatic electrical activity frequency measured using an electrical activity of the diaphragm (Edi) catheter. Values are reported as breaths per minute (breaths/min).
Time frame: From epidural electrode implantation through Day 30.
Maximum tidal volume
Maximum tidal volume measured by the mechanical ventilator during pressure support ventilation. Values are reported in milliliters (mL).
Time frame: up to 1 month
Change in peak electrical activity of the diaphragm (Edi peak) from baseline
Change in peak electrical activity of the diaphragm (Edi peak) from baseline, Change from baseline in peak electrical activity of the diaphragm measured using an Edi catheter. Values are reported in microvolts (μV).
Time frame: up to 1 month
Frequency of spontaneous breaths triggered by diaphragmatic electrical activity
The frequency of spontaneous breaths triggered by the patient's diaphragmatic electrical activity and detected using an Edi catheter. Breaths triggered solely by the mechanical ventilator without a corresponding Edi signal are excluded. Values are reported as breaths per minute (breaths/min).
Time frame: up to 1 month
Neuroventilatory efficiency (NVE)
Neuroventilatory efficiency of the diaphragm, calculated as the ratio of tidal volume to peak electrical activity of the diaphragm (VT/Edi). NVE reflects the tidal volume generated per unit of neural respiratory drive and represents the integrated performance of diaphragm function and respiratory load. Values are reported in mL/μV.
Time frame: up to 1 month
Neuro-mechanical efficiency (NME)
Neuro-mechanical efficiency of the diaphragm, calculated as the ratio of the change in airway pressure during an end-inspiratory occlusion maneuver to the corresponding peak electrical activity of the diaphragm (ΔPaw/Edi). NME reflects the pressure-generating capacity (contractile efficiency) of the diaphragm per unit of neural respiratory drive. Values are reported in cmH₂O/μV.
Time frame: up to 1 month
Airway occlusion pressure at 100 milliseconds (P0.1)
Airway occlusion pressure measured 100 milliseconds after the onset of inspiratory effort using the ventilator monitoring system. Values are reported in cmH₂O.
Time frame: up to 1 month
Airway occlusion pressure during end-expiratory occlusion (Pocc)
Airway occlusion pressure measured during an end-expiratory occlusion maneuver using the ventilator monitoring system. Values are reported in cmH₂O.
Time frame: up to 1 month
Maximum inspiratory pressure (MIP)
Maximum inspiratory pressure (MIP) measured using an inspiratory pressure measurement maneuver. MIP represents the maximum negative airway pressure generated during a maximal inspiratory effort against an occluded airway and reflects global inspiratory muscle strength. Values are reported in cmH₂O.
Time frame: up to 1 month
Diaphragm thickness
Diaphragm thickness measured by diaphragm ultrasonography. Values are reported in millimeters (mm).
Time frame: up to 1 month
Diaphragm thickening fraction
Diaphragm thickening fraction measured by diaphragm ultrasonography. Values are reported as percentages (%).
Time frame: up to 1 month
Diaphragmatic excursion
Diaphragmatic excursion measured by diaphragm ultrasonography. Values are reported in millimeters (mm).
Time frame: up to 1 month
Acute Physiology and Chronic Health Evaluation II (APACHE II) score
Disease severity assessed using the Acute Physiology and Chronic Health Evaluation II (APACHE II) score. Scores range from 0 to 71, with higher scores indicating greater disease severity and a higher risk of mortality.
Time frame: up to 1 month
Sequential Organ Failure Assessment (SOFA) score
Organ dysfunction assessed using the Sequential Organ Failure Assessment (SOFA) score. Scores range from 0 to 24, with higher scores indicating more severe organ dysfunction and worse clinical status.
Time frame: up to 1 month
Daily time off mechanical ventilation (hours/day)
Total duration per day during which the patient breathes spontaneously without mechanical ventilatory support. Values are reported in hours per day (hours/day).
Time frame: up to 1 month
Ventilator-free days within 90 days
Number of days alive and free from invasive mechanical ventilation during the first 90 days after enrollment.
Time frame: Within 90 days after enrollment.
Intensive care unit (ICU) length of stay
Length of stay in the intensive care unit, reported in days.
Time frame: up to 90 days
Hospital length of stay
Total length of hospitalization, reported in days.
Time frame: up to 90 days
Plan to share: No
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