Spinal Cord Injury CervicalNCT07722130
Epidural Spinal Cord Stimulation for Respiratory Recovery in Cervical SCI
A study testing Epidural spinal cord stimulation in people with Spinal Cord Injury Cervical and Respiratory Failure, run by Zhongda Hospital at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injury Cervical, Respiratory Failure
- What is being tested?
- Epidural spinal cord stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2026to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jianfeng Xie, Dr. PhD. contact
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210009
Wenbo Fei Li, MD. PhD., 15250963911, liwenb1@126.com
Wenbo Li, Dr.PhD.
- Recruiting
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009
Fei Peng, Dr. PhD., 15950565786, afei0312@163.com
Jianfeng Xie, Dr. PhD., jianfengxie01@seu.edu.cn
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Spinal Cord Injury Cervical, Respiratory Failure
- Being tested
- Epidural spinal cord stimulation
- Keywords
- respiratory failure, spinal cord injury, epidural spinal cord electrical stimulation, diaphragm electrical activity
- Medical subject headings
- Respiratory Insufficiency, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural spinal cord stimulationOther
①Epidural 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.
| Study group | Role | What they receive |
|---|---|---|
| Epidural spinal cord stimulation | Experimental | Not described Receives: Other: Epidural spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From epidural electrode implantation through Day 30.
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).
Measured: From epidural electrode implantation through Day 30.
Secondary outcomes (17)
Maximum tidal volume
Maximum tidal volume measured by the mechanical ventilator during pressure support ventilation. Values are reported in milliliters (mL).
Measured: up to 1 month
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).
Measured: up to 1 month
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).
Measured: up to 1 month
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.
Measured: up to 1 month
Neuro-mechanical efficiency (NME)
Neuro-mechanical efficiency of the diaphragm, calculated as the ratio of the change in airway pressure during an end-inspiratory occlusion maneuver to the corresponding peak electrical activity of the diaphragm (ΔPaw/Edi). NME reflects the pressure-generating capacity (contractile efficiency) of the diaphragm per unit of neural respiratory drive. Values are reported in cmH₂O/μV.
Measured: up to 1 month
Airway occlusion pressure at 100 milliseconds (P0.1)
Airway occlusion pressure measured 100 milliseconds after the onset of inspiratory effort using the ventilator monitoring system. Values are reported in cmH₂O.
Measured: up to 1 month
Airway occlusion pressure during end-expiratory occlusion (Pocc)
Airway occlusion pressure measured during an end-expiratory occlusion maneuver using the ventilator monitoring system. Values are reported in cmH₂O.
Measured: up to 1 month
Maximum inspiratory pressure (MIP)
Maximum inspiratory pressure (MIP) measured using an inspiratory pressure measurement maneuver. MIP represents the maximum negative airway pressure generated during a maximal inspiratory effort against an occluded airway and reflects global inspiratory muscle strength. Values are reported in cmH₂O.
Measured: up to 1 month
Diaphragm thickness
Diaphragm thickness measured by diaphragm ultrasonography. Values are reported in millimeters (mm).
Measured: up to 1 month
Diaphragm thickening fraction
Diaphragm thickening fraction measured by diaphragm ultrasonography. Values are reported as percentages (%).
Measured: up to 1 month
Diaphragmatic excursion
Diaphragmatic excursion measured by diaphragm ultrasonography. Values are reported in millimeters (mm).
Measured: up to 1 month
Acute Physiology and Chronic Health Evaluation II (APACHE II) score
Disease severity assessed using the Acute Physiology and Chronic Health Evaluation II (APACHE II) score. Scores range from 0 to 71, with higher scores indicating greater disease severity and a higher risk of mortality.
Measured: up to 1 month
Sequential Organ Failure Assessment (SOFA) score
Organ dysfunction assessed using the Sequential Organ Failure Assessment (SOFA) score. Scores range from 0 to 24, with higher scores indicating more severe organ dysfunction and worse clinical status.
Measured: up to 1 month
Daily time off mechanical ventilation (hours/day)
Total duration per day during which the patient breathes spontaneously without mechanical ventilatory support. Values are reported in hours per day (hours/day).
Measured: up to 1 month
Ventilator-free days within 90 days
Number of days alive and free from invasive mechanical ventilation during the first 90 days after enrollment.
Measured: Within 90 days after enrollment.
Intensive care unit (ICU) length of stay
Length of stay in the intensive care unit, reported in days.
Measured: up to 90 days
Hospital length of stay
Total length of hospitalization, reported in days.
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Jun 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury CervicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences
- Responsible party
- Principal investigator, Fei Peng, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722130
- Sponsor's protocol ID
- 2025010246
- Status last verified
- Sep 2026
- First submitted
- 13 Jul 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Trial of Cervical Epidural Spinal Cord Stimulation for Respiratory Recovery in Patients With Cervical Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07722130
- Acronym / sponsor ID
- 2025010246
- Conditions
- Spinal Cord Injury Cervical, Respiratory Failure
- Keywords
- respiratory failure, spinal cord injury, epidural spinal cord electrical stimulation, diaphragm electrical activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epidural spinal cord stimulation | Experimental | Other: Epidural spinal cord stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural spinal cord stimulation①Epidural 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. | Other | Epidural spinal cord stimulation |
Primary outcome
Adverse Events
Time frame: 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
Time frame: 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).
17 secondary outcomes
Maximum tidal volume
Time frame: up to 1 month
Change in peak electrical activity of the diaphragm (Edi peak) from baseline
Time frame: up to 1 month
Frequency of spontaneous breaths triggered by diaphragmatic electrical activity
Time frame: up to 1 month
Neuroventilatory efficiency (NVE)
Time frame: up to 1 month
Neuro-mechanical efficiency (NME)
Time frame: up to 1 month
Airway occlusion pressure at 100 milliseconds (P0.1)
Time frame: up to 1 month
Airway occlusion pressure during end-expiratory occlusion (Pocc)
Time frame: up to 1 month
Maximum inspiratory pressure (MIP)
Time frame: up to 1 month
Diaphragm thickness
Time frame: up to 1 month
Diaphragm thickening fraction
Time frame: up to 1 month
Diaphragmatic excursion
Time frame: up to 1 month
Acute Physiology and Chronic Health Evaluation II (APACHE II) score
Time frame: up to 1 month
Sequential Organ Failure Assessment (SOFA) score
Time frame: up to 1 month
Daily time off mechanical ventilation (hours/day)
Time frame: up to 1 month
Ventilator-free days within 90 days
Time frame: Within 90 days after enrollment.
Intensive care unit (ICU) length of stay
Time frame: up to 90 days
Hospital length of stay
Time frame: up to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianfeng Xie, Dr. PhD. contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural spinal cord stimulation in people with Spinal Cord Injury Cervical and Respiratory Failure, run by Zhongda Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fei Peng, Dr. PhD. (15950565786, afei0312@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: From epidural electrode implantation through Day 30.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.