EMG and SSEP Device (EPAD® 2.0) for Intraoperative Monitoring of Patient Undergoing Spinal Nerve Spine Surgery

NCT03848377 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2019-03-06

No results posted yet for this study

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.

Conditions

  • Spine Disease
  • Neurological Disorder

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Jason Chui, MBChB · University of Western Ontario, Canada

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2021-06-30
Completion
2021-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03848377 on ClinicalTrials.gov