Status:
COMPLETED
NAPS: Non-awake Versus Awake Placement of Spinal Cord Stimulators
Lead Sponsor:
St. Luke's Hospital, Pennsylvania
Collaborating Sponsors:
Abbott Medical Devices
Conditions:
Chronic Pain
Sciatica
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective is to demonstrate the safety and efficacy of a non-awake implantation method (EMG neuromonitoring) of a SCS paddle lead as compared to an awake implantation method (with local an...
Eligibility Criteria
Inclusion
- Patients who have had a successful spinal cord stimulation trial and are indicated for permanent implantation at a participating facility.
- Sign informed consent
Exclusion
- \< 18 years of age
Key Trial Info
Start Date :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2017
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT02284542
Start Date
November 1 2014
End Date
January 31 2017
Last Update
October 22 2021
Active Locations (4)
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1
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States, 18015
2
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
3
Penn State Hershey Neurosciences Institute
Hershey, Pennsylvania, United States, 17033
4
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107