Clinical trial NCT05098431: Comparison of Three Approaches of Electrode Placement to Detect Changes in Motor Evoked Potentials During Spine Surgery
Official title: Comparison of Three Approaches of Motor Evoked Potential Recording to Detect a More Reliable Measure to Predict and Prevent Nerve Damage During Spine Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Intervertebral Disc Degeneration
Intervertebral Disc Displacement
Spinal Stenosis
Spinal Curvatures
Spondylitis
Spondylosis
Keywords: Intraoperative Neuromonitoring
Motor Evoked Potential
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Motor Evoked Potentials recorded with an Intramuscular bipolar electrodes in the Rectus Femoris
timeFrame: Duration of surgery
measure: Motor Evoked Potentials recorded with a subcutaneous referential electrodes in the Rectus Femoris
timeFrame: Duration of surgery
measure: Motor Evoked Potentials recorded with secondary subcutaneous referential electrodes in the Rectus Femoris
timeFrame: Duration of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
Study officials:
affiliation: Allina Health
name: Jeffrey A Strommen, MD
role: PRINCIPAL_INVESTIGATOR
References: