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RECRUITING
NCT07722130
NA

Epidural Spinal Cord Stimulation for Respiratory Recovery in Cervical SCI

Sponsor: Zhongda Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-06-01

Completion Date

2029-03-31

Last Updated

2026-09-04

Healthy Volunteers

No

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.

Locations (2)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, China