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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 below
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My thigh muscles are strong and work normally.
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I am having spine surgery in my chest or lower back area where muscle monitoring is standard.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of surgery for reporting.

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

Quadriceps and Rectus Femoris MEP Recording Clinical Trial Eligibility Overview. Trial Name: NCT05098431 — N/A
Intervertebral Disc Displacement Research Study Groups: Experimental Arm
Intervertebral Disc Displacement Clinical Trial 2023: Quadriceps and Rectus Femoris MEP Recording Highlights & Side Effects. Trial Name: NCT05098431 — N/A
Quadriceps and Rectus Femoris MEP Recording 2023 Treatment Timeline for Medical Study. Trial Name: NCT05098431 — N/A
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
Email
~2 spots leftby Jul 2024