Recording of Intraoperative Spinal Cord Stimulation and Monitoring
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 21, 2011
CompletedFirst Submitted
Initial submission to the registry
April 22, 2022
CompletedFirst Posted
Study publicly available on registry
May 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 22, 2027
March 10, 2025
March 1, 2025
16 years
April 22, 2022
March 7, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change in respiratory frequency
Increase or decrease in respiratory frequency of 20% during or after stimulation
During intraoperative surgery during stimulation and within 2 minutes after stimulation
Change in respiratory tidal volume
Increase or decrease in respiratory tidal volume of 20% during or after stimulation
During intraoperative surgery during stimulation and within 2 minutes after stimulation
Secondary Outcomes (2)
Change in heart rate
During intraoperative surgery during stimulation and within 2 minutes after stimulation
Change in blood pressure
During intraoperative surgery during stimulation and within 2 minutes after stimulation
Study Arms (1)
Electrical Stimulation group
EXPERIMENTALEpidural Electrical Stimulation of the Cervical Spinal Cord
Interventions
Electrical spinal cord stimulation will be used to modulate respiratory function during general anesthesia.
Eligibility Criteria
You may qualify if:
- Any patients undergoing brain or spinal cord surgery where spinal neuromonitoring is utilized.
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, Los Angeles
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Neurosurgery
Study Record Dates
First Submitted
April 22, 2022
First Posted
May 2, 2022
Study Start
January 21, 2011
Primary Completion (Estimated)
January 22, 2027
Study Completion (Estimated)
January 22, 2027
Last Updated
March 10, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share