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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age between 18 and 75 years, with BMI \<30 kg/m².
2. Cervical SCI involving levels C1-C5 for at least 2 weeks.
3. Respiratory failure defined by one or more of the following:
* Peripheral oxygen saturation \<90% on room air;
* Arterial oxygen tension (PaO₂) \<60 mmHg;
* Respiratory acidosis (PaCO₂ \>45 mmHg with pH \<7.35);
* Requirement for mechanical ventilation.
4. Maximum inspiratory pressure (MIP) \>-15 cmH₂O.
5. Judged by the treating physician to be unable to tolerate continuous ventilator weaning for ≥48 hours due to SCI.
6. Written informed consent provided by the participant or legally authorized representative.
Exclusion Criteria:
1. Active infection at the planned electrode implantation site, severe systemic infection, or existing implanted neurostimulation devices.
2. Respiratory failure primarily caused by severe pneumonia, pulmonary contusion, pneumothorax, hemothorax, chronic obstructive pulmonary disease, or requirement for home oxygen therapy within the previous 6 months.
3. New York Heart Association (NYHA) class III or IV heart failure or implanted cardiac pacemaker.
4. Severe hepatic or renal dysfunction (Child-Pugh class C liver disease or estimated glomerular filtration rate ≤30 mL/min/1.73 m²) or dialysis dependence.
5. Generalized seizures, traumatic brain injury, intracranial hypertension, intracranial aneurysm with Glasgow Coma Scale score ≤12, or neuromuscular disorders affecting respiratory function.
6. Expected survival \<72 hours or refusal of life-sustaining treatment.
7. Pregnancy or breastfeeding.
8. Any other condition considered by the investigator to make study participation inappropriate.
Primary outcome measure(s)
Adverse Events — From epidural electrode implantation through Day 30. 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.
Diaphragmatic function — From epidural electrode implantation through Day 30. 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).
Trial sites (2)
Facility
City
Region
Status
The First Affiliated Hospital of Nanjing Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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