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

NCT05098431 | Withdrawn

• 1 other identifier: 1565509
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Intraoperative Neuromonitoring; Motor Evoked Potential

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Receive Quadriceps MEPs during procedure

Other: Quadriceps and Rectus Femoris MEP Recording

Interventions

Quadriceps and Rectus Femoris MEP Recording OTHER

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

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Allina Health System: lead

Study Sites (1)

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55447, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Bone Diseases, Infectious; Infections

Study Officials

• Jeffrey A Strommen, MD

  Allina Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: October 28, 2021
• Study Start: July 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)