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

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ClinicalTrials.gov Identifier: NCT03848377
Recruitment Status : Not yet recruiting
First Posted : February 20, 2019
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Jason Chui, Lawson Health Research Institute

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.

Condition or disease
Spine Disease Neurological Disorder

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Group/Cohort
Automated EMG/SSEP monitored

In this study, all patients will be monitored for SSEP and EMG. For SSEP monitoring, surface adhesive electrodes will be used for both stimulation and recording. After an automatic impedance check, the baseline subcortical SSEP will be established at the beginning of each case, and the amplitude and latency of the waveforms will be measured. For EMG monitoring, 6 Surface electrodes will be attached to the same muscle groups of the conventional intraoperative neurophysiological monitoring machine. In each case, the Compound Muscle Action Potentials (CMAPs) of each muscle group will be monitored.

As this is an observational study, no intervention is planned.




Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study Participants: 30 patients who are scheduled to have spine surgery in LHSC.
Criteria

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
  • BMI>40
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848377


Contacts
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Contact: Jason Chui, MBChB 5196858500 ext 35625 jason.chui@lhsc.on.ca

Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Jason Chui, MBChB University of Western Ontario, Canada

Publications:
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Responsible Party: Jason Chui, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03848377     History of Changes
Other Study ID Numbers: 112933
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jason Chui, Lawson Health Research Institute:
Spine surgery
Neuromonitoring
Evoked potential
electromyography
neurological injury

Additional relevant MeSH terms:
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Nervous System Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases