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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment up to 2 years postoperatively

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of new-onset neurological injury

Secondary outcome measures

Adverse Events

Cost analysis of IONM use

False positive and false negative events in each modality

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

163,383 Total Patients Enrolled

Media Library

Hospital Based IONM (Neuromonitoring) Clinical Trial Eligibility Overview. Trial Name: NCT04639297 — N/A

Neurological Deficits Research Study Groups: NeuroVision® IONM, Conventional hospital based IONM

Neurological Deficits Clinical Trial 2023: Hospital Based IONM Highlights & Side Effects. Trial Name: NCT04639297 — N/A

Hospital Based IONM (Neuromonitoring) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04639297 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial have any open enrollment spots?

"According to clinicaltrials.gov, this medical trial is in the process of recruiting participants. It was first made available on September 28th 2020 and last updated July 20th 2022."

Answered by AI

How many participants are engaging in this investigation?

"Affirmative. According to clinicaltrials.gov, this study is presently seeking volunteers; the trial was first uploaded on September 28th 2020 and most recently edited July 20th 2022. The experiment will include 148 participants at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

NeuroVision vs Standard Neuromonitoring

Kern Singh, MD 2020. "NeuroVision vs Standard Neuromonitoring". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04639297.

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