NeuroVision vs Standard Neuromonitoring
- Conditions
- Neurologic Deficits
- Interventions
- Device: NeuroVision® IONMDevice: Hospital Based IONM
- Registration Number
- NCT04639297
- Lead Sponsor
- Rush University Medical Center
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 148
- 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
- Active infection
- Active or history of malignancy
- Spinal traumatic injury within the past 2 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NeuroVision® IONM NeuroVision® IONM 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. Conventional hospital based IONM Hospital Based IONM 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.
- Primary Outcome Measures
Name Time Method Incidence of new-onset neurological injury Enrollment up to 2 years postoperatively Decreased somatosensory evoked potentials (SSEP) and transcranial MEPs (tcMEPs)
- Secondary Outcome Measures
Name Time Method Cost analysis of IONM use Enrollment up to 1 month post-operative Difference in costs of hospital IONM and Neurovision
False positive and false negative events in each modality Intraoperatively up to 1 day post-operative Incorrect labeling of SSEP, tcMEP, and surface electromyography (sEMG) signals
Adverse Events Postoperative to documented progress assessed up to 2 months Post-operative nausea and vomiting, Gastro-esophageal reflux, ileus, urinary tract infection, venous thromboembolic events, Respiratory depression/airway compromise,m renal insufficiency, wound complications
Trial Locations
- Locations (1)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States