Epidural Spinal Cord Stimulation for Respiratory Recovery in Cervical SCI

NCT07722130 | Recruiting DMC

• 1 other identifier: 2025010246
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Spinal Cord Injury Cervical; Respiratory Failure

Keywords

respiratory failure; spinal cord injury; epidural spinal cord electrical stimulation; diaphragm electrical activity

Outcome Measures

Primary Outcomes (2)

• 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).

  up to 1 month

• 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).

  up to 1 month

Secondary Outcomes (17)

• 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

Study Arms (1)

Epidural spinal cord stimulation

EXPERIMENTAL

Other: Epidural spinal cord stimulation

Interventions

Epidural spinal cord stimulation OTHER

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.

Epidural spinal cord stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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;
• 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.

You may not qualify 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 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.

Sponsors & Collaborators

• Zhongda Hospital: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences: collaborator

Study Sites (2)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210009, China

RECRUITING

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Fei Peng, Dr. PhD.

CONTACT

15950565786; afei0312@163.com

Jianfeng Xie, Dr. PhD.

CONTACT

jianfengxie01@seu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sub-Investigator

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 23, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)