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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05098431

Enrollment

Registered

2021-10-28

Start date

2022-07-01

Completion date

2024-01-01

Last updated

2024-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Spinal Curvatures, Spinal Stenosis, Spondylitis, Spondylosis

Keywords

Intraoperative Neuromonitoring, Motor Evoked Potential

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.

Interventions

OTHERQuadriceps and Rectus Femoris MEP Recording

Participants will receive additional electrodes placed intramuscularly to facilitate three separate approaches of quadriceps MEP recording

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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 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 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026