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NCT Number: NCT05356286

Recording of Intraoperative Spinal Cord Stimulation and Monitoring

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.

Recruiting

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Key information

Conditions

Cervical Stenosis Bone Diseases Disk, Herniated Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases Spondylosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location status: Recruiting

Location contact

Daniel Lu, MD

CONTACT

[email protected]

310-825-4321

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

epidural electrical stimulation

Device

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

Primary outcomes

  1. Change in respiratory frequency

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

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

  2. Change in respiratory tidal volume

    Time frame: 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 outcomes

  1. Change in heart rate

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

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

  2. Change in blood pressure

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Lu, MD

CONTACT

[email protected]

310/825/4321

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Important dates

Study start
2011
Primary completion
2027
Study completion
2027
First posted
May 2, 2022
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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