Epidural Spinal Cord Stimulation for Respiratory Recovery in Cervical SCI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhongda Hospital
About this trial
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 criteria
Qualifiers
Age between 18 and 75 years, with BMI <30 kg/m².
Cervical SCI involving levels C1-C5 for at least 2 weeks.
Peripheral oxygen saturation <90% on room air;
Arterial oxygen tension (PaO₂) <60 mmHg;
Disqualifiers
Active infection at the planned electrode implantation site, severe systemic infection, or existing implanted neurostimulation devices.
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.
New York Heart Association (NYHA) class III or IV heart failure or implanted cardiac pacemaker.
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.
Trial design
Treatments tested in this trial
- Epidural spinal cord stimulation
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Zhongda Hospital
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborator
Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences
Collaborator
Source ClinicalTrials.gov