Epidural Spinal Cord Stimulation for Respiratory Recovery in Cervical SCI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhongda Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 75 years, with BMI <30 kg/m².
Cervical SCI involving levels C1-C5 for at least 2 weeks.
Peripheral oxygen saturation <90% on room air;
Arterial oxygen tension (PaO₂) <60 mmHg;
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Epidural spinal cord stimulation
Other intervention①Epidural electrode implantation Under general anesthesia, two epidural electrodes will be implanted through a posterior cervical approach and positioned over the dorsal epidural space at the C3-C5 spinal levels. An implantable pulse generator will be placed in the lateral chest wall. ②.Epidural Spinal Cord Stimulation ESCS will begin on postoperative day 2. Initial stimulation parameters will include: * Pulse width: 200 μs (maximum 500μs) * Frequency: initially 10 Hz, gradually increased up to 60 Hz (maximum 300 Hz) according to tolerance * Current intensity: initially 1 mA, increased in 0.5 mA increments to the maximum tolerated intensity (up to 20 mA) Stimulation will be delivered daily. Stimulation parameters will be recorded throughout the study, and settings may be adjusted to minimize discomfort. Additional supportive care will be provided as clinically indicated.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Epidural spinal cord stimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse Events
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.
Time frame
From epidural electrode implantation through Day 30.2
Diaphragmatic function
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).
Time frame
From epidural electrode implantation through Day 30.Secondary outcomes
1
Maximum tidal volume
Maximum tidal volume measured by the mechanical ventilator during pressure support ventilation. Values are reported in milliliters (mL).
Time frame
up to 1 month2
Change in peak electrical activity of the diaphragm (Edi peak) from baseline
Change in peak electrical activity of the diaphragm (Edi peak) from baseline, Change from baseline in peak electrical activity of the diaphragm measured using an Edi catheter. Values are reported in microvolts (μV).
Time frame
up to 1 month3
Frequency of spontaneous breaths triggered by diaphragmatic electrical activity
The frequency of spontaneous breaths triggered by the patient's diaphragmatic electrical activity and detected using an Edi catheter. Breaths triggered solely by the mechanical ventilator without a corresponding Edi signal are excluded. Values are reported as breaths per minute (breaths/min).
Time frame
up to 1 month4
Neuroventilatory efficiency (NVE)
Neuroventilatory efficiency of the diaphragm, calculated as the ratio of tidal volume to peak electrical activity of the diaphragm (VT/Edi). NVE reflects the tidal volume generated per unit of neural respiratory drive and represents the integrated performance of diaphragm function and respiratory load. Values are reported in mL/μV.
Time frame
up to 1 monthSponsors and contacts
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Zhongda Hospital
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborator
Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences
Collaborator
Source ClinicalTrials.gov