NeuroVision vs Standard Neuromonitoring
ConditionNeurologic Deficits
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorRush University Medical Center
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Active infection
Active or history of malignancy
Spinal traumatic injury within the past 2 years
Trial design
Design model
Parallel
Treatments tested in this trial
NeuroVision® IONM
DeviceUsing 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
DeviceUsing 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.
Treatment groups
148 Participants
are divided into 2 treatment groupsGroup A: NeuroVision® IONMExperimental treatment 1 intervention
Group B: Conventional hospital based IONMActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of new-onset neurological injury
Decreased somatosensory evoked potentials (SSEP) and transcranial MEPs (tcMEPs)
Time frame
Enrollment up to 2 years postoperativelySecondary outcomes
1
Cost analysis of IONM use
Difference in costs of hospital IONM and Neurovision
Time frame
Enrollment up to 1 month post-operative2
False positive and false negative events in each modality
Incorrect labeling of SSEP, tcMEP, and surface electromyography (sEMG) signals
Time frame
Intraoperatively up to 1 day post-operative3
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
Time frame
Postoperative to documented progress assessed up to 2 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov