Epidural spinal cord stimulation to help breathing after cervical spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, single-arm study enrolls 20 adults with C1-C5 spinal cord injury and respiratory failure to receive epidural spinal cord stimulation implanted over the C3-C5 region, with daily tailored stimulation in addition to standard care. Primary outcomes focus on diaphragm electrical activity (Edi) and its changes, while secondary measures include lung volumes, diaphragm function on ultrasound, cough strength, ventilator-free days, ICU stay, and survival. The trial aims to establish preliminary safety and signals of efficacy to support future randomized studies. Conducted at two Chinese centers, it is investigator-initiated and the first systematic ESCES evaluation for SCI-related respiratory failure.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting
• Zhongda Hospital, Southeast University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Fei Peng, Dr. PhD.
• Email: afei0312@163.com
• Phone: 15950565786

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.