Epidural Spinal Cord Stimulation for Respiratory Recovery in Cervical SCI

Официальное название

An Exploratory Clinical Trial of Cervical Epidural Spinal Cord Stimulation for Respiratory Recovery in Patients With Cervical Spinal Cord Injury

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Epidural spinal cord stimulation
  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

Первичные конечные точки

• Peak electrical activity of the diaphragm (Edi peak) [Срок оценки: up to 1 month]
• Diaphragmatic electrical activity frequency (Edi frequency) [Срок оценки: up to 1 month]

Вторичные конечные точки (12)

• Maximum tidal volume [Срок оценки: up to 1 month]
• Change in peak electrical activity of the diaphragm (Edi peak) from baseline [Срок оценки: up to 1 month]
• Frequency of spontaneous breaths triggered by diaphragmatic electrical activity [Срок оценки: up to 1 month]
• Neuroventilatory efficiency (NVE) [Срок оценки: up to 1 month]
• Neuro-mechanical efficiency (NME) [Срок оценки: up to 1 month]
• Airway occlusion pressure at 100 milliseconds (P0.1) [Срок оценки: up to 1 month]
• Airway occlusion pressure during end-expiratory occlusion (Pocc) [Срок оценки: up to 1 month]
• Maximum inspiratory pressure (MIP) [Срок оценки: up to 1 month]
• Diaphragm thickness [Срок оценки: up to 1 month]
• Diaphragm thickening fraction [Срок оценки: up to 1 month]
• Diaphragmatic excursion [Срок оценки: up to 1 month]
• Acute Physiology and Chronic Health Evaluation II (APACHE II) score [Срок оценки: up to 1 month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• The First Affiliated Hospital of Nanjing Medical University — Нанкин
• Zhongda Hospital, Southeast University — Нанкин

Идентификаторы

NCT: NCT07722130 · 2025010246

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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