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Recording of Intraoperative Spinal Cord Stimulation and Monitoring

Primary Purpose

Cervical Stenosis, Disk, Herniated, Spondylosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
epidural electrical stimulation
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Sites / Locations

  • University of California, Los AngelesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electrical Stimulation group

Arm Description

Epidural Electrical Stimulation of the Cervical Spinal Cord

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 22, 2022
Last Updated
April 28, 2022
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT05356286
Brief Title
Recording of Intraoperative Spinal Cord Stimulation and Monitoring
Official Title
Recording of Intraoperative Spinal Cord Stimulation and Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2011 (Actual)
Primary Completion Date
January 22, 2027 (Anticipated)
Study Completion Date
January 22, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Stenosis, Disk, Herniated, Spondylosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electrical Stimulation group
Arm Type
Experimental
Arm Description
Epidural Electrical Stimulation of the Cervical Spinal Cord
Intervention Type
Device
Intervention Name(s)
epidural electrical stimulation
Intervention Description
Electrical spinal cord stimulation will be used to modulate respiratory function during general anesthesia.
Primary Outcome Measure Information:
Title
Change in respiratory frequency
Description
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
Title
Change in respiratory tidal volume
Description
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 Outcome Measure Information:
Title
Change in heart rate
Description
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
Title
Change in blood pressure
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any patients undergoing brain or spinal cord surgery where spinal neuromonitoring is utilized. Exclusion Criteria: none
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Lu, MD
Phone
310/825/4321
Email
dclu@mednet.ucla.edu
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Lu, MD
Phone
310-825-4321
Email
dclu@mednet.ucla.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Recording of Intraoperative Spinal Cord Stimulation and Monitoring

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