Recording of Intraoperative Spinal Cord Stimulation and Monitoring

Not Applicable

Recruiting

• Conditions: Disk, Herniated; Spondylosis; Cervical Stenosis
• Interventions: Device: epidural electrical stimulation

• Registration Number: NCT05356286
• Lead Sponsor: University of California, Los Angeles

Brief Summary

Opioid overdose suppresses brainstem respiratory circuits, causes apnea, and may result in death. Epidural electrical stimulation (EES) at the cervical spinal cord facilitated motor activity in rodents and humans, and we hypothesized that EES of the cervical spinal cord could antagonize opioid-induced respiratory depression in humans. In this study, we will stimulate the spinal cord during surgery and assess its effects on respiratory function in human patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-21
• Study First Submitted: 2022-04-22
• Study First Submitted QC: 2022-04-28
• Study First Posted: 2022-05-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-10
• Primary Completion: 2027-01-22
• Study Completion: 2027-01-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Any patients undergoing brain or spinal cord surgery where spinal neuromonitoring is utilized.

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electrical Stimulation group	epidural electrical stimulation	Epidural Electrical Stimulation of the Cervical Spinal Cord

Primary Outcome Measures

Name	Time	Method
Change in respiratory frequency	During intraoperative surgery during stimulation and within 2 minutes after stimulation	Increase or decrease in respiratory frequency of 20% during or after stimulation
Change in respiratory tidal volume	During intraoperative surgery during stimulation and within 2 minutes after stimulation	Increase or decrease in respiratory tidal volume of 20% during or after stimulation

Secondary Outcome Measures

Name	Time	Method
Change in heart rate	During intraoperative surgery during stimulation and within 2 minutes after stimulation	Increase or decrease in heart rate of 20% during or after stimulation
Change in blood pressure	During intraoperative surgery during stimulation and within 2 minutes after stimulation	Increase or decrease in blood pressure of 20% during or after stimulation

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States