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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05098431
Other study ID # 1565509
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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