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MEP Recording Techniques for Spine Surgery
N/A
Waitlist Available
Led By Jeffrey A Strommen, MD
Research Sponsored by Allina Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients should have normal preoperative quadriceps strength
Patients must be undergoing thoracic or lumbar spine surgery where quadriceps MEP recording would be the standard of care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of surgery
Awards & highlights
Study Summary
This trial investigates the feasibility of 3 different techniques for recording motor evoked potentials during surgery, in order to prevent damage to the spinal cord.
Who is the study for?
This trial is for adults over 18 who are undergoing thoracic or lumbar spine surgery and need motor evoked potential (MEP) monitoring, which is standard care. They must understand and sign the consent form, speak English, have normal preoperative leg strength, and not have psychiatric issues.Check my eligibility
What is being tested?
The study compares three different ways of placing electrodes to record MEPs from thigh muscles during spine surgery. It aims to determine the best method for detecting changes that could indicate spinal cord damage in real-time across 20 participants.See study design
What are the potential side effects?
Since this trial involves standard intraoperative neuromonitoring procedures with additional electrode placements, side effects may include discomfort at the electrode sites or skin irritation post-surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My thigh muscles are strong and work normally.
Select...
I am having spine surgery in my chest or lower back area where muscle monitoring is standard.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Motor Evoked Potentials recorded with a subcutaneous referential electrodes in the Rectus Femoris
Motor Evoked Potentials recorded with an Intramuscular bipolar electrodes in the Rectus Femoris
Motor Evoked Potentials recorded with secondary subcutaneous referential electrodes in the Rectus Femoris
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental ArmExperimental Treatment1 Intervention
Receive Quadriceps MEPs during procedure
Find a Location
Who is running the clinical trial?
Allina Health SystemLead Sponsor
56 Previous Clinical Trials
1,175,194 Total Patients Enrolled
2 Trials studying Intervertebral Disc Displacement
560 Patients Enrolled for Intervertebral Disc Displacement
Jeffrey A Strommen, MDPrincipal InvestigatorAllina Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My thigh muscles are strong and work normally.I am 18 years old or older.I am having spine surgery in my chest or lower back area where muscle monitoring is standard.I understand and have signed the consent form for this study.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Arm
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.
Intervertebral Disc Displacement Patient Testimony for trial: Trial Name: NCT05098431 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment period for this investigation ongoing?
"This investigation, which was first listed on July 1st 2022 and last updated February 18th 2022 according to clinicaltrials.gov, is not presently enrolling patients. Nevertheless, there are 239 other studies currently looking for volunteers."
Answered by AI
Who else is applying?
What state do they live in?
Nebraska
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
My lower back hurts a lot. I have a couple of herniated disc. I applied as I need resolution of lower back pain. This way I can work to walk normally.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
Can it help to cure some of my lower back pain?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
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