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WithdrawnNCT05098431Updated Jul 12, 2024

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

An interventional study of Quadriceps and Rectus Femoris MEP Recording in Intervertebral Disc Degeneration, Intervertebral Disc Displacement and Spinal Stenosis, sponsored by Allina Health System. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-12.

Sponsored by Allina Health System · Not applicable, Interventional, and Diagnostic

Why this study was withdrawn
Unable to enroll patients.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

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

Keywords

  • Intraoperative Neuromonitoring
  • Motor Evoked Potential
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients with ongoing psychiatric concerns would be excluded.
  • Patients who are non-English speakers.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Experimental Arm

    Receive Quadriceps MEPs during procedure

    Other: Quadriceps and Rectus Femoris MEP Recording

Interventions

  • OtherQuadriceps and Rectus Femoris MEP Recording

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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Duration of surgery

  2. 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.

    Time frame: Duration of surgery

  3. 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.

    Time frame: Duration of surgery

06

Study locations

1 site
  • Abbott Northwestern Hospital
    Minneapolis, Minnesota 55447, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05098431
Lead sponsor
Allina Health System
Responsible party
Sponsor
First posted
Oct 28, 2021
Start date
Jul 1, 2022
Primary completion
Jan 1, 2024
Completion
Jan 1, 2024
Last update
Jul 12, 2024

Study contacts

Jeffrey A Strommen, MD
principal investigator · Allina Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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