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

Allina Health System

Status: Withdrawn

Conditions: Spinal Curvatures; Intervertebral Disc Degeneration; Spondylitis; Spinal Stenosis; Spondylosis; Intervertebral Disc Displacement

Treatments: Other: Quadriceps and Rectus Femoris MEP Recording

Study type: Interventional

Funder types: Other

Identifiers

NCT05098431

1565509

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Experimental Arm

Experimental group

Description:

Receive Quadriceps MEPs during procedure

Treatment:

Other: Quadriceps and Rectus Femoris MEP Recording