RecruitingNot ApplicableNCT04639297

NeuroVision vs Standard Neuromonitoring

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


Sponsor

Rush University Medical Center

Enrollment

148 participants

Start Date

Sep 28, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Hospital Based IONM and a medical device called NeuroVision® IONM for people with neurologic deficits. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENeuroVision® 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.

DEVICEHospital 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.


Locations(1)

Rush University Medical Center

Chicago, Illinois, United States

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NCT04639297


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