NeuroVision vs Standard Neuromonitoring

Conditions

• Neurologic Deficits

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Sep 28, 2020

Status verified

Apr 2026

Primary completion

Dec 20, 2027

Completion

Dec 20, 2027

Study Design

Enrollment

148 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

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.

Primary Outcome Measure

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

Locations (1)

Find similar trials in Chicago, IL

Related Studies

• Trans-Auricular Stimulation for Postoperative Inflammation in Spine Surgery
  Recruiting · Alexander T. Yahanda · St Louis, Missouri