Evaluating MIONM Effectiveness in Predicting Postoperative Neurological Deficits Using Combined Modalities

NCT06712069 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-01-20

No results posted yet for this study

Summary

Objective: This study aimed to integrate findings from spinal and cranial surgeries with existing literature, emphasizing the role of Intraoperative Neurophysiological Monitoring (IONM) in improving surgical outcomes through best practices.

Methodology: Multimodal IONM, including motor evoked potential (MEP), somatosensory evoked potential (SSEP), and electromyography (EMG), was utilized in surgeries at Duke University Hospitals. Challenges included a small sample size and limited access to medical records.

Findings:

Effectiveness of IONM: High sensitivity (97.73%), specificity (83.33%), and predictive value of multimodal IONM confirmed its role in detecting intraoperative neurological injuries and optimizing outcomes.

Demographics: Analysis of 50 cases (58% male, aged 13-67 years) revealed demographic influences on surgical challenges and outcomes.

IONM Alerts: A 50% reduction in MEP/SSEP amplitudes was a critical criterion, with reversible alerts accounting for 70%, emphasizing the dynamic nature of neural responses.

Alert Causes \& Management: Excessive dissection was a common cause of alerts. Interventions like warm saline irrigation and surgical pauses mitigated risks.

Outcome Associations: Most patients (88%) experienced no new postoperative deficits, with significant associations between alert reversibility and deficit occurrence.

Statistical Insights:

Predictive Value: Strong correlations were observed between alert patterns and postoperative outcomes, with SSEP/MEP alerts reliably predicting neurological deficits.

Technology \& Resources: Modern devices, updated technology, and skilled staff were critical for high-quality results, highlighting the adage that "poor monitoring is worse than no monitoring."

Contextual Observations:

Heterogeneity of Cases: Diagnoses ranged from cervical intramedullary tumors to lumbar canal stenosis, requiring tailored interventions.

EMG Utility: EMG showed stability with fewer alerts, proving beneficial in specific surgeries.

Corrective Measures: Adjustments in mean arterial blood pressure and steroid use showcased adaptive intraoperative strategies.

Protocol Gaps: The absence of standardized IONM alert response protocols was noted, underscoring the need for future research.

Conditions

  • Spine Condition

Interventions

DEVICE

Multimodal Intraoperative Neurophysiologic Monitoring (MIONM)

Multimodal Intraoperative Neurophysiologic Monitoring (MIONM) is a real-time, device-based intervention used during neurosurgical procedures to monitor and preserve the integrity of neural pathways. It combines the following modalities: Somatosensory Evoked Potentials (SSEP): Monitors sensory pathways by stimulating peripheral nerves and recording cortical responses. Motor Evoked Potentials (MEP): Assesses motor pathways via transcranial stimulation and muscle response evaluation. Electromyography (EMG): Detects nerve irritation and monitors muscle activity during surgery. This intervention provides critical real-time feedback to the surgical team, enabling immediate adjustments to prevent neurological damage and enhance surgical outcomes. The Cascade IOMAX system is the primary device used in this study for implementing MIONM.

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • Mohamed H Imam, Phd in PMR · Alexandria University , Faculty of Medicine

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2023-06-01
Completion
2024-06-01
FDA Device
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06712069 on ClinicalTrials.gov