Neurologic DeficitsNCT04639297
NeuroVision vs Standard Neuromonitoring
A study testing NeuroVision® IONM and Hospital Based IONM in people with Neurologic Deficits, run by Rush University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to perform a prospective, randomized, controlled clinical trial to assess the utility of IONM in patients undergoing primary, single or multilevel lateral spinal procedures. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Neurologic Deficits
- What is being tested?
- NeuroVision® IONM and Hospital Based IONM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2020to 20 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing a primary single or multilevel lateral spinal surgery procedures for degenerative pathology Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, central stenosis, foraminal stenosis herniated nucleus pulposus, degenerative disc disease, spondylosis, and osteophytic complexes
- Patients able to provide informed consent
Who cannot join
- Active infection
- Active or history of malignancy
- Spinal traumatic injury within the past 2 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Kern Singh, MD, 3124322888, singh.research@rushortho.com
About this study
Official title: NeruoVision Versus Standard Hospital Neuromonitoring, Influence on the Rate of Neurologic Injury Following Spine Surgery? A Randomized Controlled Trial
The purpose of this study is to perform a prospective, randomized, controlled clinical trial to assess the utility of IONM in patients undergoing primary, single or multilevel lateral spinal procedures. Subjects will be randomized to undergo a lateral spine surgery with the use of NeuroVision® IONM or conventional hospital based IONM to assess incidence of new-onset neurological injury.
Read the detailed description
Elective spinal surgery for the correction of degenerative spinal pathology may involve significant intraoperative risks that can influence postoperative neurologic outcomes. Spinal cord monitoring had made it possible to track the spine and nerve root sensory and motor tracts. This has improved the ability to conduct minimally invasive surgery by allowing surgeons to operate without direct visualization of the neurologic elements.
Intraoperative neuromonitoring (IONM) of the spinal cord is primarily accomplished by both somatosensory evoked potentials (SSEP) and transcranial motor evoked potentials (tcMEPs). Due to a shortage in personnel trained to evaluate neuro-monitoring results, surgeon-driven systems have been established. An example of a surgeon driven monitoring system is NeuroVision®, which interacts with the surgeon during the operation by providing real-time visible and auditory tcMEP and compound muscle action potential (CMAP) waveforms. This stands in comparison to hospital based methods of IONM.
- Conditions
- Neurologic Deficits
- Being tested
- NeuroVision® IONM, Hospital Based IONM
- Medical subject headings
- Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroVision® IONMDevice
Using NeuroVision® prior to surgery SSEP and tcMEP and values are recorded. A deficit of SSEP tracking is defined as an amplitude reduction of more than 10% or a latency increase more than 50%. Similarly, a CMAP amplitude reduction demonstrates problematic tcMEP monitoring.
Hospital Based IONMDevice
Using hospital based IONM prior to surgery SSEP and tcMEP and values are recorded. A deficit of SSEP tracking is defined as an amplitude reduction of more than 10% or a latency increase more than 50%. Similarly, a CMAP amplitude reduction demonstrates problematic tcMEP monitoring.
| Study group | Role | What they receive |
|---|---|---|
| NeuroVision® IONM | Experimental | Patients scheduled to undergo a primary single or multilevel lateral spinal surgery procedures for non-trauma condition. Use of NeuroVision® IONM in lateral spine surgery to provide real-time visible and auditory tcMEP and CMAP waveforms. Receives: Device: NeuroVision® IONM |
| Conventional hospital based IONM | Active comparator | Patients scheduled to undergo a primary single or multilevel lateral spinal surgery procedures for non-trauma condition. Use of hospital based IONM in lateral spine surgery to provide real-time visible and auditory tcMEP and CMAP waveforms. Receives: Device: Hospital Based IONM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new-onset neurological injury
Decreased somatosensory evoked potentials (SSEP) and transcranial MEPs (tcMEPs)
Measured: Enrollment up to 2 years postoperatively
Secondary outcomes (3)
Cost analysis of IONM use
Difference in costs of hospital IONM and Neurovision
Measured: Enrollment up to 1 month post-operative
False positive and false negative events in each modality
Incorrect labeling of SSEP, tcMEP, and surface electromyography (sEMG) signals
Measured: Intraoperatively up to 1 day post-operative
Adverse Events
Post-operative nausea and vomiting, Gastro-esophageal reflux, ileus, urinary tract infection, venous thromboembolic events, Respiratory depression/airway compromise,m renal insufficiency, wound complications
Measured: Postoperative to documented progress assessed up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start28 Sep 2020
- Primary completion20 Dec 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DeficitsStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kern Singh, MD, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639297
- Sponsor's protocol ID
- 19121607
- Status last verified
- Apr 2026
- First submitted
- 17 Dec 2019
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeruoVision Versus Standard Hospital Neuromonitoring, Influence on the Rate of Neurologic Injury Following Spine Surgery? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04639297
- Acronym / sponsor ID
- 19121607
- Conditions
- Neurologic Deficits
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 20 Nov 2020 (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.
The purpose of this study is to perform a prospective, randomized, controlled clinical trial to assess the utility of IONM in patients undergoing primary, single or multilevel lateral spinal procedures. Subjects will be randomized to undergo a lateral spine surgery with the use of NeuroVision® IONM or conventional hospital based IONM to assess incidence of new-onset neurological injury.
Detailed description
Elective spinal surgery for the correction of degenerative spinal pathology may involve significant intraoperative risks that can influence postoperative neurologic outcomes. Spinal cord monitoring had made it possible to track the spine and nerve root sensory and motor tracts. This has improved the ability to conduct minimally invasive surgery by allowing surgeons to operate without direct visualization of the neurologic elements.
Intraoperative neuromonitoring (IONM) of the spinal cord is primarily accomplished by both somatosensory evoked potentials (SSEP) and transcranial motor evoked potentials (tcMEPs). Due to a shortage in personnel trained to evaluate neuro-monitoring results, surgeon-driven systems have been established. An example of a surgeon driven monitoring system is NeuroVision®, which interacts with the surgeon during the operation by providing real-time visible and auditory tcMEP and compound muscle action potential (CMAP) waveforms. This stands in comparison to hospital based methods of IONM.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeuroVision® IONM | Experimental | Device: NeuroVision® IONMPatients scheduled to undergo a primary single or multilevel lateral spinal surgery procedures for non-trauma condition. Use of NeuroVision® IONM in lateral spine surgery to provide real-time visible and auditory tcMEP and CMAP waveforms. |
| Conventional hospital based IONM | Active comparator | Device: Hospital Based IONMPatients scheduled to undergo a primary single or multilevel lateral spinal surgery procedures for non-trauma condition. Use of hospital based IONM in lateral spine surgery to provide real-time visible and auditory tcMEP and CMAP waveforms. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing a primary single or multilevel lateral spinal surgery procedures for degenerative pathology Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, central stenosis, foraminal stenosis herniated nucleus pulposus, degenerative disc disease, spondylosis, and osteophytic complexes
- Patients able to provide informed consent
Key exclusion criteria (3 listed)
- Active infection
- Active or history of malignancy
- Spinal traumatic injury within the past 2 years
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 |
|---|---|---|
| NeuroVision® IONMUsing NeuroVision® prior to surgery SSEP and tcMEP and values are recorded. A deficit of SSEP tracking is defined as an amplitude reduction of more than 10% or a latency increase more than 50%. Similarly, a CMAP amplitude reduction demonstrates problematic tcMEP monitoring. | Device | NeuroVision® IONM |
| Hospital Based IONMUsing hospital based IONM prior to surgery SSEP and tcMEP and values are recorded. A deficit of SSEP tracking is defined as an amplitude reduction of more than 10% or a latency increase more than 50%. Similarly, a CMAP amplitude reduction demonstrates problematic tcMEP monitoring. | Device | Conventional hospital based IONM |
Primary outcome
Incidence of new-onset neurological injury
Time frame: Enrollment up to 2 years postoperatively
Decreased somatosensory evoked potentials (SSEP) and transcranial MEPs (tcMEPs)
3 secondary outcomes
Cost analysis of IONM use
Time frame: Enrollment up to 1 month post-operative
False positive and false negative events in each modality
Time frame: Intraoperatively up to 1 day post-operative
Adverse Events
Time frame: Postoperative to documented progress assessed up to 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroVision® IONM and Hospital Based IONM in people with Neurologic Deficits, run by Rush University Medical Center at 1 site in United States.
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 2 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: looking for participants now, as of the sponsor's last update on 7 Apr 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of new-onset neurological injury (time frame: Enrollment up to 2 years postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2026.