Status:
UNKNOWN
EMG and SSEP Device (EPAD® 2.0) for Intraoperative Monitoring of Patient Undergoing Spinal Nerve Spine Surgery
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Spine Disease
Neurological Disorder
Eligibility:
All Genders
18+ years
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...
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 undergoi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03848377
Start Date
July 1 2019
End Date
June 1 2021
Last Update
March 6 2019
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