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New treatment option for Spinal Cord Injury Cervical
Official title Epidural Spinal Cord Stimulation for Respiratory Recovery in Cervical SCI
ClinicalTrials.gov ID: NCT07722130
What this study is testing
- What it's testing
- 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.
- Time commitment: about 30 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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;
You likely can't join 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...
- 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...
- Generalized seizures, traumatic brain injury, intracranial hypertension, intracranial aneurysm with Glasgow Coma Scale score ≤12, or neuromuscular...
- Expected survival \<72 hours or refusal of life-sustaining treatment.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 30 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.