Spine ConditionMIONMNCT06712069
Evaluating MIONM Effectiveness in Predicting Postoperative Neurological Deficits Using Combined Modalities
A study testing Multimodal Intraoperative Neurophysiologic Monitoring (MIONM) in people with Spine Condition, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Spine Condition
- What is being tested?
- Multimodal Intraoperative Neurophysiologic Monitoring (MIONM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Usefulness of Multimodal Intraoperative Neurophysiologic Monitoring During Brain or Spine Surgeries
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.
Read more
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.
Read the 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.
- Conditions
- Spine Condition
- Being tested
- Multimodal Intraoperative Neurophysiologic Monitoring (MIONM)
- Keywords
- Multimodal IONM, SSEP, MEP, EMG, brain, spine surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Multimodal Intraoperative Neurophysiologic Monitoring (MIONM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Evaluated within one-week post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Feb 2023
- Primary completion1 Jun 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spine ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed El Sakka, Alexandria University
- Investigators
- Mohamed H Imam, Phd in PMR, Study chair, Alexandria University , Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712069
- Sponsor's protocol ID
- 0201578
- Other IDs
- Assistant Lecturer of PMR
- Acronym
- MIONM
- Status last verified
- Jan 2025
- First submitted
- 15 Nov 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) from this study will not be shared with other researchers to protect participant confidentiality and privacy. Additionally, institutional and ethical guidelines restrict the sharing of such data outside the scope of this study. The collected data will be used solely for the analysis and reporting of study results
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usefulness of Multimodal Intraoperative Neurophysiologic Monitoring During Brain or Spine Surgeries
- ClinicalTrials.gov ID
- NCT06712069
- Acronym / sponsor ID
- MIONM / 0201578
- Conditions
- Spine Condition
- Keywords
- Multimodal IONM, SSEP, MEP, EMG, brain, spine surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Multimodal Intraoperative Neurophysiologic Monitoring (MIONM) Arm | Experimental | Device: Multimodal Intraoperative Neurophysiologic Monitoring (MIONM)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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Multimodal Intraoperative Neurophysiologic Monitoring (MIONM) Arm |
Primary outcome
rate of occurrence of New Postoperative Neurological Deficits
Time frame: Evaluated within one-week post-surgery.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Background1. 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) from this study will not be shared with other researchers to protect participant confidentiality and privacy. Additionally, institutional and ethical guidelines restrict the sharing of such data outside the scope of this study. The collected data will be used solely for the analysis and reporting of study results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed H Imam, Phd in PMR study chair
Alexandria University , Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Intraoperative Neurophysiologic Monitoring (MIONM) in people with Spine Condition, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of occurrence of New Postoperative Neurological Deficits (time frame: Evaluated within one-week post-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06712069, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.