NeuroVision Monitoring for Spinal Surgery Safety

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Active infection, Malignancy, Spinal injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Intraoperative

148 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment NeuroVision Monitoring for Spinal Surgery Safety?

Intraoperative neurophysiological monitoring (IONM) is shown to be valuable for detecting and preventing nerve damage during spine surgery, improving surgical outcomes, and serving as a safety measure. It is considered the standard of care in many places, providing a safety net to prevent or minimize nerve damage during complex spinal surgeries. ^{1 2 3 4 5}

Is NeuroVision Monitoring for Spinal Surgery generally safe for humans?

Intraoperative neurophysiological monitoring (IONM), including NeuroVision Monitoring, is widely used during surgeries to help prevent nerve damage by monitoring nerve function in real time. It is considered a standard and safe practice in many surgical procedures, including spinal surgeries, to improve safety and outcomes. ^{2 3 6 7 8}

How is NeuroVision Monitoring for Spinal Surgery Safety different from other treatments?

NeuroVision Monitoring, or intraoperative neurophysiological monitoring (IONM), is unique because it uses a combination of neurophysiological tests to monitor the spinal cord and nerve function during surgery, helping to prevent nerve damage by providing real-time feedback to the surgical team. This approach is particularly valuable in complex spinal surgeries, as it allows for early detection of potential issues, which can improve surgical outcomes and reduce the risk of postoperative complications. ^{1 2 3 5 9}

Eligibility Criteria

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.

Inclusion Criteria

Patients able to provide informed consent

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

Exclusion Criteria

I currently have an infection.

I have or had cancer.

I have had a spinal injury in the last 2 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo lateral spinal surgery with either NeuroVision® IONM or conventional hospital-based IONM

Intraoperative

1 visit (in-person)

Immediate Post-operative Monitoring

Participants are monitored for false positive and false negative events in IONM modalities

1 day

Follow-up

Participants are monitored for adverse events and new-onset neurological injury

2 months

Long-term Follow-up

Participants are assessed for incidence of new-onset neurological injury

2 years

Treatment Details

Interventions

• Hospital Based IONM
• NeuroVision® IONM

Trial Overview 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.

Participant Groups

Group I: NeuroVision® IONM Experimental Treatment 1 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 IONM Active Control 1 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.

Hospital Based IONM is already approved in European Union, United States for the following indications:

Approved in European Union as Intraoperative Neurophysiological Monitoring for:

• Spinal deformity correction
• Spinal tumor resection
• High-grade spondylolisthesis reduction

Approved in United States as Intraoperative Neurophysiological Monitoring for:

• Spinal deformity correction
• Spinal tumor resection
• Complex spinal procedures

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Findings from Research

In a review of 46 cases of lumbar intradural schwannoma resection, the use of intraoperative multimodal neuromonitoring (IONM) did not lead to any additional motor deficits post-surgery, indicating its safety in this context.

Although IONM did not change clinical outcomes compared to surgeries without it, it is still preferred for its ability to enhance surgeon confidence and provide important data for medicolegal situations, despite the increased costs and longer surgery times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Neurophysiologic Monitoring for Lumbar Intradural Schwannomas: Does It Affect Clinical Outcome? Kahraman, S., Gocmen, S., Alpsan Gokmen, MH., et al.[2023]

Intraoperative neuromonitoring (IONM) was used in 18% of pediatric scoliosis surgeries and was associated with a higher likelihood of patients being discharged home, indicating a potential benefit in postoperative recovery.

While IONM showed a trend towards reducing neurologic complications (0.9% with IONM vs. 1.4% without), this finding was not statistically significant, suggesting further research is needed to confirm its efficacy in preventing such complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Intraoperative Neuromonitoring on the Outcomes of Surgeries for Pediatric Scoliosis in the United States. George, J., Das, S., Egger, AC., et al.[2020]

In a study of 26 patients undergoing spinal surgery, multimodal intraoperative neurophysiological monitoring (IONM) effectively combined methods like motor evoked potentials (MEP) and somatosensory evoked potentials (SSEP) to enhance the safety and outcomes of surgeries involving spinal cord pathologies.

The monitoring revealed significant changes in MEPs and SSEPs in some patients, helping to identify risks during surgery; however, postoperative neurological deficits occurred in 2 patients, highlighting the importance of IONM in maintaining neural integrity during complex spinal procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal Intraoperative Neurophysiological Monitoring in Spinal Cord Surgery. Taskiran, E., Brandmeier, S., Ozek, E., et al.[2018]

Multimodal intraoperative neurophysiological monitoring (IONM) during cervical spine surgery effectively detects potential spinal cord injuries during patient positioning, with transcranial motor evoked potentials (TcMEP) showing 100% sensitivity.

In cases where IONM warnings were issued due to loss of TcMEP, most patients recovered after repositioning, highlighting the importance of IONM in preventing neurological deficits during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of multimodal intraoperative neurophysiological monitoring during positioning of patient prior to cervical spine surgery. Plata Bello, J., Pérez-Lorensu, PJ., Roldán-Delgado, H., et al.[2022]

Intraoperative neurophysiologic monitoring (IONM) is crucial during spinal surgery as it helps assess the functional integrity of the spinal cord and peripheral nerves, allowing for early detection of potential nerve damage.

By using multimodal monitoring techniques, IONM provides real-time feedback to the surgical team, enabling timely interventions that can prevent or reduce postoperative neurological deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative neurophysiologic monitoring during spinal surgery. Devlin, VJ., Schwartz, DM.[2022]

Intraoperative neurophysiologic monitoring (IONM) is increasingly used in surgeries to alert teams to potential injuries, particularly preventing ulnar neuropathy during prone positioning and severe arm abduction.

IONM techniques, such as somatosensory evoked potential monitoring and electroencephalography, enhance patient safety by detecting vascular compromise and impending ischemic events, although the choice of anesthesia can impact monitoring effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative neurophysiologic monitoring: utility and anesthetic implications. Gunter, A., Ruskin, KJ.[2018]

In a study of 400 vagal nerve dissections, continuous intraoperative neuromonitoring (C-IONM) showed no additional local or systemic complications, indicating its safety during surgical procedures.

The research found that using a 3 mm electrode on vagal nerves smaller than 2 mm increased the risk of electrode dislocation, highlighting the importance of appropriate electrode sizing and placement for effective monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous intraoperative neuromonitoring in thyroid surgery: Safety analysis of 400 consecutive electrode probe placements with standardized procedures. Mangano, A., Kim, HY., Wu, CW., et al.[2018]

The study developed a hybrid CNN-LSTM model that achieved an impressive 89.54% accuracy and 94.23% sensitivity in classifying electromyogram (EMG) waveforms during intraoperative neurophysiological monitoring (IONM), indicating its effectiveness in real-time nerve assessment.

By automating the classification of EMG signals, this approach could enhance surgical safety by minimizing communication delays and reducing variability in interpretation among different practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Deep Learning Model for Automated Classification of Intraoperative Continuous EMG. Zha, X., Wehbe, L., Sclabassi, RJ., et al.[2022]

In a study of 169 patients undergoing spinal surgery with intraoperative neurophysiological monitoring (IONM), signal changes were detected in 26.6% of cases, but most were resolved by repositioning the patient, indicating that IONM can help identify potential issues during surgery.

Despite the detection of signal changes, patients with unresolved signals did not experience postoperative deficits, suggesting that IONM's effectiveness may be limited, with a high false positive rate of 38% and a low false negative rate of 1.8%, highlighting the need for careful clinical judgment in its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the Role of Intraoperative Neurophysiological Monitoring in Spinal Surgery With a Focus on the True and False Positives and a Clinical Correlation. Murphy, B., Murphy, E., Irwin, J., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Intraoperative Neurophysiologic Monitoring for Lumbar Intradural Schwannomas: Does It Affect Clinical Outcome? [2023]

2. England pubmed.ncbi.nlm.nih.gov

Influence of Intraoperative Neuromonitoring on the Outcomes of Surgeries for Pediatric Scoliosis in the United States. [2020]

3. Turkey pubmed.ncbi.nlm.nih.gov

Multimodal Intraoperative Neurophysiological Monitoring in Spinal Cord Surgery. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Role of multimodal intraoperative neurophysiological monitoring during positioning of patient prior to cervical spine surgery. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Intraoperative neurophysiologic monitoring during spinal surgery. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Intraoperative neurophysiologic monitoring: utility and anesthetic implications. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Continuous intraoperative neuromonitoring in thyroid surgery: Safety analysis of 400 consecutive electrode probe placements with standardized procedures. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

A Deep Learning Model for Automated Classification of Intraoperative Continuous EMG. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Review of the Role of Intraoperative Neurophysiological Monitoring in Spinal Surgery With a Focus on the True and False Positives and a Clinical Correlation. [2022]