NCT06712069: MIONM

Evaluating MIONM Effectiveness in Predicting Postoperative Neurological Deficits Using Combined Modalities

Completed NA Last updated 20 January 2025

What this trial tests

NA trial testing Multimodal Intraoperative Neurophysiologic Monitoring (MIONM) in Spine Condition in 50 participants. Completed in 1 June 2024.

Timeline

1 February 2023

Primary endpoint
1 June 2023

1 June 2024

Quick facts

Lead sponsor	Alexandria University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	50
Start date	1 February 2023
Primary completion	1 June 2023
Estimated completion	1 June 2024
Sites	1 location across Egypt

Drugs / interventions tested

• Multimodal Intraoperative Neurophysiologic Monitoring (MIONM)

Conditions studied

• Spine Condition — all drugs for Spine Condition →

Sponsor

Alexandria University

Who can join

12 and older, any sex, with Spine Condition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.