RecruitingNot Applicable

NeuroVision vs Standard Neuromonitoring

United States148 participantsStarted 2020-09-28

Plain-language 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.

Who can participate

SexALL

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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

What they're measuring

Incidence of new-onset neurological injury

Timeframe: Enrollment up to 2 years postoperatively

Trial details

NCT IDNCT04639297

SponsorRush University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-20

View on ClinicalTrials.gov More Neurologic Deficits trials