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

Spinal Stenosis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05098431
• Other study ID #: 1565509
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: July 15, 2024

Study information

• Verified date: March 2023
• Source: Allina Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: July 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Quadriceps and Rectus Femoris MEP Recording
Participants will receive additional electrodes placed intramuscularly to facilitate three separate approaches of quadriceps MEP recording

Locations

Country	Name	City	State
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Allina Health System

Country where clinical trial is conducted

United States, 

Outcome

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