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Device
Epidural Electrical Stimulation for Spinal Cord Disorders
N/A
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Any patients undergoing brain or spinal cord surgery where spinal neuromonitoring is utilized.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during intraoperative surgery during stimulation and within 2 minutes after stimulation
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether electrical stimulation of the spinal cord can help people with respiratory depression from an opioid overdose.
Who is the study for?
This trial is for patients who are undergoing brain or spinal cord surgery and where monitoring of the spinal cord's activity is used. There are no specific exclusion criteria, so it appears open to all eligible surgical candidates.
What is being tested?
The study tests if epidural electrical stimulation (EES) at the cervical spine can counteract opioid-induced breathing problems during surgery. It will record how EES affects motor activity and respiratory function in human patients.
What are the potential side effects?
While not explicitly stated, potential side effects may include discomfort from the stimulation, temporary nerve issues, or skin irritation at the electrode site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having brain or spinal surgery with monitoring.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during intraoperative surgery during stimulation and within 2 minutes after stimulation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during intraoperative surgery during stimulation and within 2 minutes after stimulation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in respiratory frequency
Tidal Volume
Secondary study objectives
Change in blood pressure
Change in heart rate
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Electrical Stimulation groupExperimental Treatment1 Intervention
Epidural Electrical Stimulation of the Cervical Spinal Cord
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,568 Previous Clinical Trials
10,314,122 Total Patients Enrolled
1 Trials studying Spondylosis
20 Patients Enrolled for Spondylosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having brain or spinal surgery with monitoring.Not applicable.
Research Study Groups:
This trial has the following groups:- Group 1: Electrical Stimulation group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.