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 Withdrawn at 1 site in United States.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
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).
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:
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.
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
Browse Intervertebral Disc Degeneration studies →Allina Health System is the lead sponsor of 38 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receive Quadriceps MEPs during procedure
Other: Quadriceps and Rectus Femoris MEP Recording
Participants will receive additional electrodes placed intramuscularly to facilitate three separate approaches of quadriceps MEP recording
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
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
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2022 to primary completion in Jan 2024, 18 months.
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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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Intervertebral Disc Degeneration →
Allina Health System