Clinical trial NCT06712069: Evaluating MIONM Effectiveness in Predicting Postoperative Neurological Deficits Using Combined Modalities
Official title: The Usefulness of Multimodal Intraoperative Neurophysiologic Monitoring During Brain or Spine Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spine Condition
Keywords: Multimodal IONM, SSEP, MEP, EMG, brain, spine surgery
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: PREVENTION

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.

Detailed description: Detailed Description:

The discussion emphasizes the importance of intraoperative neurophysiological monitoring (IONM) in enhancing surgical safety during spinal and cranial procedures. Multimodal IONM (MIONM), incorporating somatosensory evoked potentials (SSEP), motor evoked potentials (MEP), and electromyography (EMG), serves as a critical tool for real-time neurological monitoring during these complex operations.

MIONM is highlighted for its ability to detect intraoperative neurological changes, enabling timely interventions. Factors such as patient demographics and case heterogeneity, including diverse diagnoses like craniotomy, lumbar canal stenosis, scoliosis, and cervical intramedullary tumors, underscore the need for tailored surgical approaches. The integration of modern equipment and experienced personnel ensures the delivery of high-quality monitoring results.

The discussion also explores the challenges in managing IONM alerts, including causes like over-dissection, hypoperfusion, and excessive cord manipulation. A multimodal approach to handling alerts includes interventions such as positional adjustments, warm saline irrigation, and optimizing blood flow. The absence of standardized protocols for responding to alerts highlights the need for future research to develop evidence-based guidelines.

Further research is encouraged to refine IONM methodologies, customize surgical strategies based on patient-specific factors, and establish standardized alert response protocols to optimize outcomes in spinal and cranial surgeries.

Eligibility criteria: Inclusion Criteria:

1. Age \> 12 years.
2. 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.
3. Medically fit for surgery.

Exclusion Criteria:

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

Primary outcomes:
measure: rate of occurrence of New Postoperative Neurological Deficits
timeFrame: Evaluated within one-week post-surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Main University Hospital (AMUH)
Study officials:
affiliation: Alexandria University , Faculty of Medicine
name: Mohamed H Imam, Phd in PMR
role: STUDY_CHAIR
References:
citation: 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.