AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Epidural Spinal Cord Stimulation for Respiratory Recovery in Cervical SCI

RecruitingNAAges 18 Years - 75 YearsAllZhongda Hospital
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
💊

What it tests

  • Epidural spinal cord stimulation
📍

Where

2 sites
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China
Zhongda Hospital, Southeast University
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy