Comparison of Three Approaches of Electrode Placement to Detect Changes in Motor Evoked Potentials During Spine Surgery
Primary Purpose
Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Spinal Stenosis
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quadriceps and Rectus Femoris MEP Recording
Sponsored by
About this trial
This is an interventional diagnostic trial for Intervertebral Disc Degeneration focused on measuring Intraoperative Neuromonitoring, Motor Evoked Potential
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.
Sites / Locations
- Abbott Northwestern Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental Arm
Arm Description
Receive Quadriceps MEPs during procedure
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05098431
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
July 15, 2024 (Anticipated)
Study Completion Date
July 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allina Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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:
Using transcranial magnetic stimulation, evaluate the effects on compound muscle action potentials utilizing intramuscular bipolar recording vs subdermal referential recordings vs subdermal bipolar recordings.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Spinal Stenosis, Spinal Curvatures, Spondylitis, Spondylosis
Keywords
Intraoperative Neuromonitoring, Motor Evoked Potential
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
Receive Quadriceps MEPs during procedure
Intervention Type
Other
Intervention Name(s)
Quadriceps and Rectus Femoris MEP Recording
Intervention Description
Participants will receive additional electrodes placed intramuscularly to facilitate three separate approaches of quadriceps MEP recording
Primary Outcome Measure Information:
Title
Motor Evoked Potentials recorded with an Intramuscular bipolar electrodes in the Rectus Femoris
Description
MEPs will be evoked throughout the duration of the surgery. MEPs will be recorded in the Rectus Femoris using intramuscular bipolar electrodes.
Time Frame
Duration of surgery
Title
Motor Evoked Potentials recorded with a subcutaneous referential electrodes in the Rectus Femoris
Description
MEPs will be evoked throughout the duration of the surgery. Electrodes will be placed in the Rectus Femoris to serve as a reference.
Time Frame
Duration of surgery
Title
Motor Evoked Potentials recorded with secondary subcutaneous referential electrodes in the Rectus Femoris
Description
MEPs will be evoked throughout the duration of the surgery. Electrodes will be placed in the Rectus Femoris to serve as a reference.
Time Frame
Duration of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey A Strommen, MD
Organizational Affiliation
Allina Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55447
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Three Approaches of Electrode Placement to Detect Changes in Motor Evoked Potentials During Spine Surgery
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