Recording of Intraoperative Spinal Cord Stimulation and Monitoring

April 28, 2022 updated by: Daniel Lu, MD, PhD, University of California, Los Angeles
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California, Los Angeles
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Electrical Stimulation group
Epidural Electrical Stimulation of the Cervical Spinal Cord
Device: epidural electrical stimulation
Electrical spinal cord stimulation will be used to modulate respiratory function during general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During intraoperative surgery during stimulation and within 2 minutes after stimulation
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
During intraoperative surgery during stimulation and within 2 minutes after stimulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During intraoperative surgery during stimulation and within 2 minutes after stimulation
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
During intraoperative surgery during stimulation and within 2 minutes after stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 21, 2011

Primary Completion (ANTICIPATED)

January 22, 2027

Study Completion (ANTICIPATED)

January 22, 2027

Study Registration Dates

First Submitted

April 22, 2022

First Submitted That Met QC Criteria

April 28, 2022

First Posted (ACTUAL)

May 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 2, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-000043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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