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

Not Applicable

Withdrawn

• Conditions: Spinal Stenosis; Intervertebral Disc Displacement; Spondylitis; Spondylosis; Intervertebral Disc Degeneration; Spinal Curvatures
• Interventions: Other: Quadriceps and Rectus Femoris MEP Recording

• Registration Number: NCT05098431
• Lead Sponsor: Allina Health System

Brief Summary

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).

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 Timeline

• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-10-27
• Study First Posted: 2021-10-28
• Study Start: 2022-07-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Arm	Quadriceps and Rectus Femoris MEP Recording	Receive Quadriceps MEPs during procedure

Primary Outcome Measures

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

Trial Locations

Locations (1)

Abbott Northwestern Hospital; 🇺🇸 Minneapolis, Minnesota, United States