Comparison of Three Approaches of Electrode Placement to Detect Changes in Motor Evoked Potentials During Spine Surgery

Comparison of Three Approaches of Motor Evoked Potential Recording to Detect a More Reliable Measure to Predict and Prevent Nerve Damage During Spine Surgery

Motor Evoked Potentials are an aspect of intraoperative neuromonitoring, a tool used by neurophysiologists during surgery to prevent irreversible damage to the spinal cord during procedures. This study investigates the utility of three separate quadriceps MEP recording approaches over a total of 40 limbs (20 participants).

Study Overview

• Status: Enrolling by invitation
• Conditions: Intervertebral Disc Displacement; Spinal Curvatures; Intervertebral Disc Degeneration; Spondylitis; Spinal Stenosis; Spondylosis
• Intervention / Treatment: Other: Quadriceps and Rectus Femoris MEP Recording

Detailed Description

The long-term objective of this research is to understand how differing recording techniques may enhance the ability to accurately identify clinically relevant changes in Motor Evoked Potentials (MEPs) during a variety of surgeries where the central motor tracts or lumbar spinal roots are at risk.The specific aims of the proposed research are:

1. Using transcranial magnetic stimulation, evaluate the effects on compound muscle action potentials utilizing intramuscular bipolar recording vs subdermal referential recordings vs subdermal bipolar recordings.
2. Evaluated the variability of amplitude and area between the intramuscular and subdermal recording techniques.

The initial focus will be on recording techniques to obtain stable MEPs in a proximal lower limb muscle, specifically the quadriceps. Continuation research may focus on stimulation techniques to facilitate proximal MEPs and ultimately to improved specificity of MEP changes.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maxwell J Klaiman, BA; Phone Number: 612-863-4088; Email: Maxwell.Klaiman@allina.com

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55447
      • Abbott Northwestern Hospital

Participation Criteria

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:

• Patients must be ≥18 years of age
• Patients must be undergoing thoracic or lumbar spine surgery where quadriceps MEP recording would be the standard of care
• Patients should have normal preoperative quadriceps strength
• Patients are capable of understanding the informed consent and have signed the informed consent document prior to any study-specific screening procedures or evaluations being performed

Exclusion Criteria:

• Patients with ongoing psychiatric concerns would be excluded.
• Patients who are non-English speakers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm; Receive Quadriceps MEPs during procedure	Other: Quadriceps and Rectus Femoris MEP Recording; Participants will receive additional electrodes placed intramuscularly to facilitate three separate approaches of quadriceps MEP recording

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Evoked Potentials recorded with an Intramuscular bipolar electrodes in the Rectus Femoris	MEPs will be evoked throughout the duration of the surgery. MEPs will be recorded in the Rectus Femoris using intramuscular bipolar electrodes.	Duration of surgery
Motor Evoked Potentials recorded with a subcutaneous referential electrodes in the Rectus Femoris	MEPs will be evoked throughout the duration of the surgery. Electrodes will be placed in the Rectus Femoris to serve as a reference.	Duration of surgery
Motor Evoked Potentials recorded with secondary subcutaneous referential electrodes in the Rectus Femoris	MEPs will be evoked throughout the duration of the surgery. Electrodes will be placed in the Rectus Femoris to serve as a reference.	Duration of surgery

Collaborators and Investigators

• Sponsor: Allina Health System
• Investigators: Principal Investigator: Jeffrey A Strommen, MD, Allina Health

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Anticipated): July 15, 2024
• Study Completion (Anticipated): July 15, 2024

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Intraoperative Neuromonitoring; Motor Evoked Potential
• Additional Relevant MeSH Terms: Infections; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Bone Diseases, Infectious; Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Spinal Stenosis; Spondylitis; Spondylosis; Spinal Curvatures
• Other Study ID Numbers: 1565509

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: No
• product manufactured in and exported from the U.S.: No