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
|Condition or disease|
|Spine Disease Neurological Disorder|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|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|
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.
- 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).
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
|Contact: Jason Chui, MBChB||5196858500 ext firstname.lastname@example.org|
|Principal Investigator:||Jason Chui, MBChB||University of Western Ontario, Canada|