Evaluating MIONM Effectiveness in Predicting Postoperative Neurological Deficits Using Combined Modalities

NCT06712069 | Completed FDA Device

• 2 other identifiers: 0201578Assistant Lecturer of PMR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Multimodal IONM, SSEP, MEP, EMG, brain, spine surgery

Outcome Measures

Primary Outcomes (1)

• rate of occurrence of New Postoperative Neurological Deficits

  The primary outcome is the proportion of patients who develop new neurological deficits (motor, sensory, or combined) after undergoing neurosurgical procedures with Multimodal Intraoperative Neurophysiologic Monitoring (MIONM). These deficits will be assessed through detailed clinical examinations pre- and post-surgery.

  Evaluated within one-week post-surgery.

Study Arms (1)

Multimodal Intraoperative Neurophysiologic Monitoring (MIONM) Arm

EXPERIMENTAL

This arm involves the application of Multimodal Intraoperative Neurophysiologic Monitoring (MIONM) during neurosurgical procedures. Participants in this arm undergo continuous intraoperative monitoring using a combination of: Somatosensory Evoked Potentials (SSEP): Monitoring sensory pathway integrity. Motor Evoked Potentials (MEP): Assessing motor pathway functionality. Electromyography (EMG): Detecting nerve irritation and monitoring cranial and limb muscles. The intervention is designed to enhance surgical precision by providing real-time feedback to the surgical team, aiming to prevent postoperative neurological deficits and improve patient outcomes. Pre- and postoperative clinical assessments are conducted to evaluate the effectiveness of MIONM.

Device: Multimodal Intraoperative Neurophysiologic Monitoring (MIONM)

Interventions

Multimodal Intraoperative Neurophysiologic Monitoring (MIONM) DEVICE

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.

Multimodal Intraoperative Neurophysiologic Monitoring (MIONM) Arm

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 12 years.
• Various brain or spinal pathologies that are indicated for (IONM) such as (cerebellopontine angle tumors, scoliosis, epidural abscesses, arteriovenous malformations, canal stenosis, tumor resection, and craniotomies.
• Medically fit for surgery.

You may not qualify if:

• Unobtainable or poor baselines (both MEPs and SSEPs).
• Patients with a motor power grade of 1 or below.
• Presence of vascular clips, intracranial electrodes, pacemakers, other implanted biomechanical equipment, cortical lesions, skull defects, increased intracranial pressure, and history of epilepsy.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Main University Hospital (AMUH)

Alexandria, 21526, Egypt

Location

Related Publications (1)

• 1. Brandmeier S, Taskiran E, Bolukbasi FH, Sari R, Elmaci I. Multimodal intraoperative neurophysiological monitoring in neurosurgical oncology. Turk Neurosurg 2018;28(2):204-10. 2. Novak K, Oberndorfer S. Electrophysiology and intraoperative neurophysiological monitoring. In: Handbook of Clinical Neurology 2012; 104:149-61. 3. Miró Lladó J, López-Ojeda P, Pedro J, Marnov A, Contreras L, Pariente L, et al. Evaluation of multimodal intraoperative neurophysiologic monitoring during supratentorial aneurysm surgery: a comparative study. Neurosurg Rev 2022 ;45(3):2161-73. 4. Tsirikos AI, Duckworth AD, Henderson LE, Michaelson C. Multimodal intraoperative spinal cord monitoring during spinal deformity surgery: efficacy, diagnostic characteristics, and algorithm development. Med Princ Pract 2020;29(1):6-17. 5. Cavinato M, Vittoria F, Piccione F, Masiero S, Carbone M. The value of intraoperative neurophysiological monitoring during positioning in pediatric scoliosis correction: A case report. Clin Neurophysiol Pract 2022; 7:366-71. 6. Park JH, Hyun SJ. Intraoperative neurophysiological monitoring in spinal surgery. World J Clin Cases 2015;3(9):765.

  BACKGROUND

Study Officials

• Mohamed H Imam, Phd in PMR

  Alexandria University , Faculty of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of PMR

Model Details: The interventional study in my work , titled "The Usefulness of Multimodal Intraoperative Neurophysiologic Monitoring During Brain or Spine Surgeries," employs a single-group, prospective observational design to evaluate the efficacy of Multimodal Intraoperative Neurophysiologic Monitoring (MIONM) in preventing postoperative neurological deficits. Below are the key elements of the study model: Interventional Study Model : Design: Type: Interventional, Prospective Observational Single Group Assignment: All participants undergo the same intervention using MIONM during their neurosurgical procedures. No Control Group: The outcomes of MIONM use are directly compared with expected standards of care based on existing literature

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: December 2, 2024
• Study Start: February 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)