A Feasibility Study of a Novel Combined Automated EMG and SSEP Device (EPAD® 2.0) for Intraoperative Monitoring of Spinal Nerve Roots and Spinal Cord Function During Spine Surgery
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 30
- Primary Endpoint
- The feasibility of using EPAD 2.0 automated device to successfully monitor the patients in spine surgery.
Study Overview
Brief Summary
In patients undergoing spine surgery, spinal nerve roots and spinal cord are vulnerable to surgical insults especially for instrumentation and may lead to long term sequelae. The incidence of clinical peripheral neuropathy after cervical spine surgery has been reported up to 30%. Intraoperatively, spinal cord and nerves function can be monitored using electromyography (EMG) and somatosensory evoked potentials (SSEP) and thereby, intervention can be made to potentially reduce the incidence of adverse neurological sequelae. However, conventional EMG and SSEP monitoring requires presence of a trained EP technician, use of needle electrodes and currently bulky EP equipment and is thus not practical for routine clinical usage. In this study, the invesitgators will assess the clinical feasibility of using a novel miniaturized and automated EMG/SSEP device (EPAD® 2.0) in spine surgical patients.
Detailed Description
Purpose of Research: This study is a pilot study designed to assess the ability of a novel automated EMG/SSEP device (EPAD® 2.0) to detect intraoperative spinal nerve roots injury in patients undergoing spine procedures. The specific aims are:
- to assess the clinical utility of using the EPAD® 2.0 automated device and its algorithm in monitoring spine surgery patients.
- to identify any practical limitation of using EPAD® 2.0 automated device in spine surgery patients.
Hypothesis: the novel automated EPAD® 2.0 EMG/SSEP device is easy to use and apply in spine surgery patients
BACKGROUND Surgical injuries to the spinal nerve roots or spinal cords are not infrequent in spine surgery and the consequence can be devastating. Injured patients might present with radiculopathy, motor weakness, spinal cord compression, and postoperative neuropathic pain. In cervical spine surgery, cervical nerve roots injuries especially fifth cervical (C5) nerve root are not uncommon complications, potentially resulting in upper extremity paralysis. The incidence of C5 nerve root injury ranged to as high as 30%. The other spinal nerve roots (C6-8) can suffer from the same surgical injuries during the procedure but with much lower reported incidence than C5. Spinal nerve injuries typically occur during decompression for cervical myelopathy in both anterior and posterior approaches. In lumbosacral spine surgery, a recent review of the neurological injury found a pooled incidence of 5.7% (56 of 2783 patients; range: 0.46-24%), in which pedicle malposition accounted for one-fifth of the injuries.
A multimodality monitoring such as SSEP and EMG can be used in spine surgery to allow comprehensive monitoring of the spinal cord and nerve roots function and an attempt to reduce the risks of surgical injuries. Although the idea of closely monitoring of spinal cord and nerve roots function during high-risk cervical spine instrumentation procedure is appealing, the utilization of intraoperative neurophysiological monitoring is limited. One reason is the current requirements for a trained technician and for electrode placement and observation of monitoring SSSEP signals, the requirement for the use of needle electrodes for SSEP monitoring and specific training for a neurophysiologist in the interpretation of SSEP signals.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patient (age>18 years old)
- •Scheduled to have either cervical or lumbosacral spine surgery. We include all patients who will undergo either single or multiple instrumented or non-instrumented decompression/fusion with either allograft or autograft bone with a preoperative diagnosis of cervical stenosis, radiculopathy, herniated nucleus pulposus, junctional stenosis, or non-union from prior surgery.
Exclusion Criteria
- •Age <18 years old
- •Unable to perform preoperative neurological examination such as the language barrier
- •Fluctuating neurological signs/symptoms (eg. recent CVA, peripheral neuropathy, etc)
- •Unable to obtain informed consent
- •Contraindication to EP monitoring - skin burns or trauma at EP electrode sites
Outcomes
Primary Outcomes
The feasibility of using EPAD 2.0 automated device to successfully monitor the patients in spine surgery.
Time Frame: Intraoperative
The feasibility is determined by the percentage of patients being successfully monitored in spine surgery using the EPAD 2.0 automated device (i.e. \[number of patients being successfully monitored/ total number of patients being recruited\]\*100).
Secondary Outcomes
No secondary outcomes reported
Investigators
Jason Chui
Principal Investigator
Lawson Health Research Institute