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Neuromonitoring

NeuroVision Monitoring for Spinal Surgery Safety

N/A

Recruiting

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Active infection

Active or history of malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment up to 2 years postoperatively

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess whether a new type of spinal surgery results in less neurological injuries than the conventional method.

Who is the study for?

This trial is for patients who can consent and are having their first single or multilevel lateral spinal surgery due to conditions like myelopathy, radiculopathy, stenosis, herniated discs, degenerative disc disease, spondylosis. It's not for those with recent spinal trauma, active infections or a history of cancer.

What is being tested?

The study compares two types of intraoperative neuromonitoring (IONM) during lateral spine surgery: NeuroVision® IONM and standard hospital-based IONM. The goal is to see which method better prevents new neurological injuries.

What are the potential side effects?

While the side effects aren't specified here since IONM generally monitors nerve function during surgery rather than treating it directly; any potential risks would likely relate to the surgical procedure itself rather than the monitoring technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having spine surgery for a condition like herniated disc or spinal stenosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an infection.

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I have or had cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment up to 2 years postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment up to 2 years postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment up to 2 years postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of new-onset neurological injury

Secondary study objectives

Adverse Events

Cost analysis of IONM use

False positive and false negative events in each modality

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NeuroVision® IONMExperimental Treatment1 Intervention

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.

Group II: Conventional hospital based IONMActive Control1 Intervention

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.

0 / 3Eligibility criteria met