Epidural Spinal Cord Stimulation for Respiratory Recovery in Cervical SCI
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07722130, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Zhongda Hospital
- Trial code
- NCT07722130
- Record updated
- 4 September 2026
- Original description
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.Read full original descriptionShow less
An Exploratory Clinical Trial of Cervical Epidural Spinal Cord Stimulation for Respiratory Recovery in Patients With Cervical Spinal Cord Injury
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.
Inclusion: 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.
Exclusion: 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; Active infection at the planned electrode implantation site, severe systemic infection, or existing implanted neurostimulation devices; 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; Any other condition considered by the investigator to make study participation inappropriate; Expected survival <72 hours or refusal of life-sustaining treatment; Pregnancy or breastfeeding.