NeuroVision vs Standard Neuromonitoring

Overview

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.

Full Title of Study: “NeruoVision Versus Standard Hospital Neuromonitoring, Influence on the Rate of Neurologic Injury Following Spine Surgery? A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: September 28, 2021

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.

Interventions

  • Device: NeuroVision® IONM
    • 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.
  • Device: Hospital Based IONM
    • 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.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Active Comparator: Conventional 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.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of new-onset neurological injury
    • Time Frame: 2 years postoperatively
    • Decreased somatosensory evoked potentials (SSEP) and transcranial MEPs (tcMEPs)

Secondary Measures

  • Cost analysis of IONM use
    • Time Frame: Admission to discharge, up to 1 month
    • Difference in costs of hospital IONM and Neurovision
  • False positive and false negative events in each modality
    • Time Frame: Intraoperatively, from procedure start time to end time
    • Incorrect labeling of SSEP, tcMEP, and surface electromyography (sEMG) signals
  • Adverse Events
    • Time Frame: Postoperative to discharge, up to 1 month
    • Post-operative nausea and vomiting, Gastro-esophageal reflux, ileus, urinary tract infection, venous thromboembolic events, Respiratory depression/airway compromise,m renal insufficiency, wound complications

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: N/A

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • Rush University Medical Center
    • Provider of Information About this Clinical Study
      • Principal Investigator: Kern Singh, Professor, Attending Physician – Rush University Medical Center

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