Recruiting

NeuroVision® IONM

Sponsor:

Rush University Medical Center

Code:

NCT04639297

Conditions

Neurologic Deficits

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

NeuroVision® IONM

Hospital Based IONM

Study Details

Brief 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. 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.

Conditions

Neurologic Deficits

Study ID

NCT04639297

Start date

Sep 28, 2020

Status verified date

Apr, 2026

Completion date

Dec 20, 2027

Anticipated

Primary completion date

Dec 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Active infection
  • Active or history of malignancy
  • Spinal traumatic injury within the past 2 years

Study Design

Enrollment

148 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: NeuroVision® IONM

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.

active comparator: Conventional hospital based IONM

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.

Interventions

NeuroVision® IONM

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 IONM

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.

Primary outcome measure

  • Incidence of new-onset neurological injury [ Time Frame: Enrollment up to 2 years postoperatively ]

Central Contacts and Locations

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Kern Singh, MD

3124322888singh.research@rushortho.com

More Information

Sponsor

Rush University Medical Center

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-04-07.