WithdrawnNot Applicable

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

Stopped: Unable to enroll patients.

United States0Started 2022-07-01

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Motor Evoked Potentials recorded with an Intramuscular bipolar electrodes in the Rectus Femoris

Timeframe: Duration of surgery

Motor Evoked Potentials recorded with a subcutaneous referential electrodes in the Rectus Femoris

Timeframe: Duration of surgery

Motor Evoked Potentials recorded with secondary subcutaneous referential electrodes in the Rectus Femoris

Timeframe: Duration of surgery

Trial details

NCT IDNCT05098431

SponsorAllina Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-01

View on ClinicalTrials.gov More Intervertebral Disc Degeneration trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Motor Evoked Potentials recorded with an Intramuscular bipolar electrodes in the Rectus Femoris

Timeframe: Duration of surgery

Motor Evoked Potentials recorded with a subcutaneous referential electrodes in the Rectus Femoris

Timeframe: Duration of surgery

Motor Evoked Potentials recorded with secondary subcutaneous referential electrodes in the Rectus Femoris

Timeframe: Duration of surgery