NeuroVision vs Standard Neuromonitoring

Neurologic Deficits Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Neurologic Deficits
• Neurologic Manifestations

• NCT number: NCT04639297
• Study type: Interventional
• Source: Rush University Medical Center
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2020
• Completion date: June 20, 2026