NeuroVision vs Standard Neuromonitoring

NCT04639297 | Recruiting FDA Device

• 1 other identifier: 19121607
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of new-onset neurological injury

  Decreased somatosensory evoked potentials (SSEP) and transcranial MEPs (tcMEPs)

  Enrollment up to 2 years postoperatively

Secondary Outcomes (3)

• Cost analysis of IONM use

  Enrollment up to 1 month post-operative

• False positive and false negative events in each modality

  Intraoperatively up to 1 day post-operative

• Adverse Events

  Postoperative to documented progress assessed up to 2 months

Study Arms (2)

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.

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.

Device: Hospital Based IONM

Interventions

NeuroVision® IONM DEVICE

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.

NeuroVision® IONM

Hospital Based IONM DEVICE

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.

Conventional hospital based IONM

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Neurologic Manifestations

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Attending Physician

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: November 20, 2020
• Study Start: September 28, 2020
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): June 20, 2027
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)