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Epidural Spinal Cord Stimulation for Respiratory Recovery in Cervical SCI

18 luglio 2026 aggiornato da: Fei Peng, Zhongda Hospital

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Fei Peng, Dr. PhD.
  • Numero di telefono: 15950565786
  • Email: afei0312@163.com

Backup dei contatti dello studio

Luoghi di studio

  • Cina
    • Jiangsu
      • Nanjing, Jiangsu, Cina, 210009
        • Reclutamento
        • Zhongda Hospital, Southeast University
        • Contatto:
        • Contatto:
        • Sub-investigatore:
          • Fei Peng, Dr.PhD.
        • Investigatore principale:
          • Jianfeng Xie, Dr.PhD.
      • Nanjing, Jiangsu, Cina, 210009
        • Reclutamento
        • The First Affiliated Hospital of Nanjing Medical University
        • Contatto:
          • Wenbo Fei Li, MD. PhD.
          • Numero di telefono: 15250963911
          • Email: liwenb1@126.com
        • Sub-investigatore:
          • Wenbo Li, Dr.PhD.
        • Investigatore principale:
          • Jin Fan, Dr.PhD.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Age between 18 and 75 years, with BMI <30 kg/m².
  2. Cervical SCI involving levels C1-C5 for at least 2 weeks.

  3. 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.
  4. Maximum inspiratory pressure (MIP) >-15 cmH₂O.
  5. Judged by the treating physician to be unable to tolerate continuous ventilator weaning for ≥48 hours due to SCI.
  6. Written informed consent provided by the participant or legally authorized representative.

Exclusion Criteria:

  1. Active infection at the planned electrode implantation site, severe systemic infection, or existing implanted neurostimulation devices.
  2. 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.
  3. New York Heart Association (NYHA) class III or IV heart failure or implanted cardiac pacemaker.
  4. 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.
  5. Generalized seizures, traumatic brain injury, intracranial hypertension, intracranial aneurysm with Glasgow Coma Scale score ≤12, or neuromuscular disorders affecting respiratory function.
  6. Expected survival <72 hours or refusal of life-sustaining treatment.
  7. Pregnancy or breastfeeding.
  8. Any other condition considered by the investigator to make study participation inappropriate.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Epidural spinal cord stimulation
Altro: 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 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Peak electrical activity of the diaphragm (Edi peak)
Lasso di tempo: 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).
up to 1 month
Diaphragmatic electrical activity frequency (Edi frequency)
Lasso di tempo: 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).
up to 1 month

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Maximum tidal volume
Lasso di tempo: up to 1 month
Maximum tidal volume measured by the mechanical ventilator during pressure support ventilation. Values are reported in milliliters (mL).
up to 1 month
Change in peak electrical activity of the diaphragm (Edi peak) from baseline
Lasso di tempo: up to 1 month
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).
up to 1 month
Frequency of spontaneous breaths triggered by diaphragmatic electrical activity
Lasso di tempo: up to 1 month
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).
up to 1 month
Neuroventilatory efficiency (NVE)
Lasso di tempo: up to 1 month
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.
up to 1 month
Neuro-mechanical efficiency (NME)
Lasso di tempo: up to 1 month
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.
up to 1 month
Airway occlusion pressure at 100 milliseconds (P0.1)
Lasso di tempo: up to 1 month
Airway occlusion pressure measured 100 milliseconds after the onset of inspiratory effort using the ventilator monitoring system. Values are reported in cmH₂O.
up to 1 month
Airway occlusion pressure during end-expiratory occlusion (Pocc)
Lasso di tempo: up to 1 month
Airway occlusion pressure measured during an end-expiratory occlusion maneuver using the ventilator monitoring system. Values are reported in cmH₂O.
up to 1 month
Maximum inspiratory pressure (MIP)
Lasso di tempo: up to 1 month
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.
up to 1 month
Diaphragm thickness
Lasso di tempo: up to 1 month
Diaphragm thickness measured by diaphragm ultrasonography. Values are reported in millimeters (mm).
up to 1 month
Diaphragm thickening fraction
Lasso di tempo: up to 1 month
Diaphragm thickening fraction measured by diaphragm ultrasonography. Values are reported as percentages (%).
up to 1 month
Diaphragmatic excursion
Lasso di tempo: up to 1 month
Diaphragmatic excursion measured by diaphragm ultrasonography. Values are reported in millimeters (mm).
up to 1 month
Acute Physiology and Chronic Health Evaluation II (APACHE II) score
Lasso di tempo: up to 1 month
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.
up to 1 month
Sequential Organ Failure Assessment (SOFA) score
Lasso di tempo: up to 1 month
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.
up to 1 month
Daily time off mechanical ventilation (hours/day)
Lasso di tempo: up to 1 month
Total duration per day during which the patient breathes spontaneously without mechanical ventilatory support. Values are reported in hours per day (hours/day).
up to 1 month
Ventilator-free days within 90 days
Lasso di tempo: Within 90 days after enrollment.
Number of days alive and free from invasive mechanical ventilation during the first 90 days after enrollment.
Within 90 days after enrollment.
Intensive care unit (ICU) length of stay
Lasso di tempo: up to 90 days
Length of stay in the intensive care unit, reported in days.
up to 90 days
Hospital length of stay
Lasso di tempo: up to 90 days
Total length of hospitalization, reported in days.
up to 90 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Zhongda Hospital

Collaboratori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 giugno 2026

Completamento primario (Stimato)

31 dicembre 2028

Completamento dello studio (Stimato)

31 marzo 2029

Date di iscrizione allo studio

Primo inviato

13 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 luglio 2026

Primo Inserito (Effettivo)

23 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2025010246

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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