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Epidural Spinal Cord Stimulation for Respiratory Recovery in Brain Injury

NCT07766681 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-08-14

No results posted yet for this study

Summary

Patients with severe brain injury may develop impaired respiratory drive, diaphragm dysfunction, prolonged mechanical ventilation, and difficulty recovering spontaneous breathing. Epidural spinal cord stimulation may activate preserved spinal respiratory circuits and improve respiratory muscle activity. This prospective, single-center, non-randomized, single-arm exploratory study will enroll 10 patients with stroke or traumatic brain injury who have impaired consciousness and require invasive mechanical ventilation. Participants will undergo epidural spinal cord stimulation in addition to standard clinical care. Diaphragmatic electrical activity, respiratory function, diaphragm ultrasound findings, diaphragm electromyography, duration of mechanical ventilation, pulmonary infection, length of stay, mortality, safety events, and 6-month neurological outcome will be assessed. The study aims to evaluate the safety and preliminary efficacy of epidural spinal cord stimulation for improving respiratory function after brain injury.

Conditions

Interventions

PROCEDURE

Epidural Electrode Implantation

Participants will undergo surgical implantation of an epidural spinal cord stimulation electrode under anesthesia. The electrode will be positioned at the spinal level specified in the final surgical protocol and connected to a stimulation system.

Sponsors & Collaborators

  • The 904th Hospital of the People's Liberation Army of China

    collaborator UNKNOWN

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

    collaborator UNKNOWN

  • Chinese PLA General Hospital

    collaborator OTHER

  • Zhongda Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-08-05
Primary Completion
2028-02-28
Completion
2028-12-31

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 NCT07766681 on ClinicalTrials.gov