NeuroVision vs Standard Neuromonitoring

Study Overview
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Brief Summary
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The purpose of this study is to perform a prospective, randomized, controlled clinical trial to assess the utility of IONM in patients undergoing primary, single or multilevel lateral spinal procedures. Subjects will be randomized to undergo a lateral spine surgery with the use of NeuroVision® IONM or conventional hospital based IONM to assess incidence of new-onset neurological injury.

Detailed Description
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Elective spinal surgery for the correction of degenerative spinal pathology may involve significant intraoperative risks that can influence postoperative neurologic outcomes. Spinal cord monitoring had made it possible to track the spine and nerve root sensory and motor tracts. This has improved the ability to conduct minimally invasive surgery by allowing surgeons to operate without direct visualization of the neurologic elements. Intraoperative neuromonitoring (IONM) of the spinal cord is primarily accomplished by both somatosensory evoked potentials (SSEP) and transcranial motor evoked potentials (tcMEPs). Due to a shortage in personnel trained to evaluate neuro-monitoring results, surgeon-driven systems have been established. An example of a surgeon driven monitoring system is NeuroVision®, which interacts with the surgeon during the operation by providing real-time visible and auditory tcMEP and compound muscle action potential (CMAP) waveforms. This stands in comparison to hospital based methods of IONM.

Official Title
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NeruoVision Versus Standard Hospital Neuromonitoring, Influence on the Rate of Neurologic Injury Following Spine Surgery? A Randomized Controlled Trial

Conditions
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Neurologic Deficits

Intervention / Treatment
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* Device: NeuroVision® IONM
* Device: Hospital Based IONM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing a primary single or multilevel lateral spinal surgery procedures for degenerative pathology Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, central stenosis, foraminal stenosis herniated nucleus pulposus, degenerative disc disease, spondylosis, and osteophytic complexes Patients able to provide informed consent Exclusion Criteria: Active infection Active or history of malignancy Spinal traumatic injury within the past 2 years
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeuroVision® IONM<br>Patients scheduled to undergo a primary single or multilevel lateral spinal surgery procedures for non-trauma condition. Use of NeuroVision® IONM in lateral spine surgery to provide real-time visible and auditory tcMEP and CMAP waveforms. | Device: NeuroVision® IONM<br>* Using NeuroVision® prior to surgery SSEP and tcMEP and values are recorded. A deficit of SSEP tracking is defined as an amplitude reduction of more than 10% or a latency increase more than 50%. Similarly, a CMAP amplitude reduction demonstrates problematic tcMEP monitoring.<br>|
| Active Comparator: Conventional hospital based IONM<br>Patients scheduled to undergo a primary single or multilevel lateral spinal surgery procedures for non-trauma condition. Use of hospital based IONM in lateral spine surgery to provide real-time visible and auditory tcMEP and CMAP waveforms. | Device: Hospital Based IONM<br>* Using hospital based IONM prior to surgery SSEP and tcMEP and values are recorded. A deficit of SSEP tracking is defined as an amplitude reduction of more than 10% or a latency increase more than 50%. Similarly, a CMAP amplitude reduction demonstrates problematic tcMEP monitoring.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of new-onset neurological injury | Decreased somatosensory evoked potentials (SSEP) and transcranial MEPs (tcMEPs) | Enrollment up to 2 years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost analysis of IONM use | Difference in costs of hospital IONM and Neurovision | Enrollment up to 1 month post-operative | 
| False positive and false negative events in each modality | Incorrect labeling of SSEP, tcMEP, and surface electromyography (sEMG) signals | Intraoperatively up to 1 day post-operative | 
| Adverse Events | Post-operative nausea and vomiting, Gastro-esophageal reflux, ileus, urinary tract infection, venous thromboembolic events, Respiratory depression/airway compromise,m renal insufficiency, wound complications | Postoperative to documented progress assessed up to 2 months |