Spinal Stenosis Clinical Trial
Official title:
Comparison of Three Approaches of Motor Evoked Potential Recording to Detect a More Reliable Measure to Predict and Prevent Nerve Damage During Spine Surgery
Verified date | March 2023 |
Source | Allina Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
Country | Name | City | State |
---|---|---|---|
United States | Abbott Northwestern Hospital | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Allina Health System |
United States,
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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