Epidural Spinal Cord Stimulation for Respiratory Recovery in Cervical SCI
Recruiting now · Not applicable
Conditions studied: Spinal Cord Injury Cervical, Respiratory Failure
In brief
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.
Key facts
- Study ID
- NCT07722130
- Run by
- Zhongda Hospital
- People needed
- 20
- Starts
- 2026-06-01
- Expected to finish
- 2029-03-31
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age between 18 and 75 years, with BMI <30 kg/m².
- Cervical SCI involving levels C1-C5 for at least 2 weeks.
- 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.
- Maximum inspiratory pressure (MIP) >-15 cmH₂O.
- Judged by the treating physician to be unable to tolerate continuous ventilator weaning for ≥48 hours due to SCI.
- Written informed consent provided by the participant or legally authorized representative.
You may not qualify if…
- 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.
- Generalized seizures, traumatic brain injury, intracranial hypertension, intracranial aneurysm with Glasgow Coma Scale score ≤12, or neuromuscular disorders affecting respiratory function.
- Expected survival <72 hours or refusal of life-sustaining treatment.
- Pregnancy or breastfeeding.
- Any other condition considered by the investigator to make study participation inappropriate.
Where it is running
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
- Zhongda Hospital, Southeast University — Nanjing, Jiangsu, China (enrolling)
Full record on ClinicalTrials.gov
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