An Exploratory Clinical Trial of Cervical Epidural Spinal Cord Stimulation for Respiratory Recovery in Patients With Cervical Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Peak electrical activity of the diaphragm (Edi peak)
研究概览
简要总结
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.
详细描述
This is a multicenter, prospective, single-arm, exploratory investigator-initiated trial (IIT) conducted at Zhongda Hospital, Southeast University and the First Affiliated Hospital of Nanjing Medical University. The study aims to evaluate the safety and efficacy of epidural spinal cord electrical stimulation (ESCES) in patients with spinal cord injury (SCI) complicated by respiratory failure.
A total of 20 adult patients (aged 18-75 years) with C1-C5 level SCI for at least 2 weeks and respiratory failure requiring mechanical ventilation or presenting with hypoxemia/hypercapnia will be enrolled. Participants will receive standard conventional treatment plus ESCES. Electrodes will be surgically implanted at the C3-C5 epidural space, and stimulation will be delivered daily with individualized parameter titration based on patient tolerance.
The primary outcomes are Edi peak, change of Edi peak and frequency. Secondary outcomes include tidal volume, diaphragmatic ultrasound parameters, cough strength, 90-day ventilator-free days, ICU length of stay, and survival at 90 and 180 days.
The observation period is defined as the period from enrollment until 1 month after enrollment or until successful weaning from mechanical ventilation, ICU discharge, removal of the epidural stimulation electrode, withdrawal from the study, or death, whichever occurs first.
This study is the first systematic exploration of ESCES for respiratory function recovery in SCI patients with respiratory failure, and may provide a novel therapeutic strategy for this population. The trial is expected to run for approximately 30 months. Participation is voluntary, and participants may withdraw at any time without affecting their subsequent care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Epidural spinal cord stimulation
干预措施: Epidural spinal cord stimulation (Other)
结局指标
主要结局
Peak electrical activity of the diaphragm (Edi peak)
时间窗: up to 1 month
Peak electrical activity of the diaphragm measured using an electrical activity of the diaphragm (Edi) catheter. Values are reported in microvolts (μV).
Diaphragmatic electrical activity frequency (Edi frequency)
时间窗: up to 1 month
Diaphragmatic electrical activity frequency measured using an electrical activity of the diaphragm (Edi) catheter. Values are reported as breaths per minute (breaths/min).
Adverse Events
时间窗: From epidural electrode implantation through Day 30.
Incidence of Adverse Events and Serious Adverse Events Related to Epidural Spinal Cord Stimulation; Safety will be assessed by the occurrence of adverse events (AEs) and serious adverse events (SAEs) considered possibly, probably, or definitely related to epidural electrode implantation, the stimulation device, or epidural spinal cord stimulation.
Diaphragmatic function
时间窗: From epidural electrode implantation through Day 30.
Peak electrical activity of the diaphragm (Edi peak): Peak electrical activity of the diaphragm measured using an electrical activity of the diaphragm (Edi) catheter. Values are reported in microvolts (μV). Diaphragmatic electrical activity frequency (Edi frequency): Diaphragmatic electrical activity frequency measured using an electrical activity of the diaphragm (Edi) catheter. Values are reported as breaths per minute (breaths/min).
次要结局
- Maximum tidal volume(up to 1 month)
- Change in peak electrical activity of the diaphragm (Edi peak) from baseline(up to 1 month)
- Frequency of spontaneous breaths triggered by diaphragmatic electrical activity(up to 1 month)
- Neuroventilatory efficiency (NVE)(up to 1 month)
- Neuro-mechanical efficiency (NME)(up to 1 month)
- Airway occlusion pressure at 100 milliseconds (P0.1)(up to 1 month)
- Airway occlusion pressure during end-expiratory occlusion (Pocc)(up to 1 month)
- Maximum inspiratory pressure (MIP)(up to 1 month)
- Diaphragm thickness(up to 1 month)
- Diaphragm thickening fraction(up to 1 month)
- Diaphragmatic excursion(up to 1 month)
- Acute Physiology and Chronic Health Evaluation II (APACHE II) score(up to 1 month)
- Sequential Organ Failure Assessment (SOFA) score(up to 1 month)
- Daily time off mechanical ventilation (hours/day)(up to 1 month)
- Ventilator-free days within 90 days(Within 90 days after enrollment.)
- Intensive care unit (ICU) length of stay(up to 90 days)
- Hospital length of stay(up to 90 days)
研究者
Fei Peng
Sub-Investigator
Zhongda Hospital