Skip to main content
Clinical Trials/NCT05098431
NCT05098431
Withdrawn
Not Applicable

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

Allina Health System1 site in 1 countryJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intervertebral Disc Degeneration
Sponsor
Allina Health System
Locations
1
Primary Endpoint
Motor Evoked Potentials recorded with a subcutaneous referential electrodes in the Rectus Femoris
Status
Withdrawn
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
January 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Motor Evoked Potentials recorded with a subcutaneous referential electrodes in the Rectus Femoris

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

Loading locations...

Similar Trials