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Epidural Spinal Cord Stimulation for Respiratory Recovery in Cervical SCI

NCT07722130 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-07-23

No results posted yet for this study

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences

    collaborator UNKNOWN

  • Zhongda Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-12-31
Completion
2029-03-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07722130 on ClinicalTrials.gov