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RecruitingNCT05356286Updated Mar 10, 2025

Recording of Intraoperative Spinal Cord Stimulation and Monitoring

An interventional study of epidural electrical stimulation in Cervical Stenosis, Disk, Herniated and Spondylosis, sponsored by University of California, Los Angeles. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-10.

Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 years 3 months after the study started (first participant enrolled Jan 2011, registered Apr 2022).
  • Started Jan 2011; still recruiting 15 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cervical Stenosis
  • Disk, Herniated
  • Spondylosis
03

In context

Spondylosis

144 studies on the registry are indexed under Spondylosis; 41 are open to participants now.

This study's planned enrollment of 150 is above the median of 60 across 99 interventional studies indexed under Spondylosis.

Browse Spondylosis studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Electrical Stimulation group

    Epidural Electrical Stimulation of the Cervical Spinal Cord

    Device: epidural electrical stimulation

Interventions

  • Deviceepidural electrical stimulation

    Electrical spinal cord stimulation will be used to modulate respiratory function during general anesthesia.

06

What researchers measure

Primary outcomes

  1. Change in respiratory frequency

    Increase or decrease in respiratory frequency of 20% during or after stimulation

    Time frame: During intraoperative surgery during stimulation and within 2 minutes after stimulation

  2. Change in respiratory tidal volume

    Increase or decrease in respiratory tidal volume of 20% during or after stimulation

    Time frame: During intraoperative surgery during stimulation and within 2 minutes after stimulation

Secondary outcomes

  1. Change in heart rate

    Increase or decrease in heart rate of 20% during or after stimulation

    Time frame: During intraoperative surgery during stimulation and within 2 minutes after stimulation

  2. Change in blood pressure

    Increase or decrease in blood pressure of 20% during or after stimulation

    Time frame: During intraoperative surgery during stimulation and within 2 minutes after stimulation

07

Study locations

1 of 1 sites recruiting
  • University of California, Los Angeles
    Los Angeles, California 90095, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05356286
Lead sponsor
University of California, Los Angeles
Responsible party
Daniel Lu, MD, PhD (Professor, Neurosurgery, University of California, Los Angeles) — Principal investigator
First posted
May 2, 2022
Start date
Jan 21, 2011
Primary completion
Jan 22, 2027 (estimated)
Completion
Jan 22, 2027 (estimated)
Last update
Mar 10, 2025

Study contacts

Daniel Lu, MD
Contact
dclu@mednet.ucla.edu
310/825/4321

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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