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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05098431
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Allina Health System
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jeffrey A Strommen, MD
Principal Investigator Affiliation	Allina Health
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Spinal Stenosis, Spinal Curvatures, Spondylitis, Spondylosis

Additional Details

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.#46;subdermal referential recordings vs.#46;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.

Arms & Interventions

Arms

Experimental: Experimental Arm

Receive Quadriceps MEPs during procedure

Interventions

Other: - Quadriceps and Rectus Femoris MEP Recording

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Abbott Northwestern Hospital, Minneapolis, Minnesota

Status

Address

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55447

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