NAPS: Non-awake Versus Awake Placement of Spinal Cord Stimulators
Study Details
Study Description
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 anesthesia and patient feedback).This is a post-market, prospective, multicenter, parallel designed, non-randomized, non-blinded, 6-month study. A minimum of 50 patients will be implanted from up to 4 active sites, coordinated by a single lead investigator.
Patients who have had a successful SCS trial and are indicated for permanent implantation will be approached to participate in this study prior to permanent implantation. Patients will be recruited and enrolled by physicians at any one of the involved sites. Each Investigator will only use one method (awake or non-awake) according to his/her typical practice. Patients will receive treatment from their enrolling physician.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with successful trial implant Patients who have had a successful SCS trial and are indicated for permanent implantation will be approached to participate in this study prior to permanent implantation. Patients will be recruited and enrolled by physicians at any one of the involved sites. Each Investigator will only use one method (awake or non-awake) according to his/her typical practice. Patients will receive treatment from their enrolling physician. |
Procedure: Awake
Upon approximate lead positioning, the patient is brought to a conscious sedated state while maintaining local anesthetic. Stimulation of the spinal cord through the paddle lead is accomplished with an external pulse generator, while communicating with the patient regarding paresthesia coverage of painful regions.
Procedure: Non-Awake
The patient is maintained under general anesthesia for the full duration of the implant. Upon approximate lead positioning, bilateral EMG of myotomes overlapping dermatomal regions of pain are monitored. Stimulation is delivered through the lead by an external pulse generator in order to elicit compound muscle action potentials (CMAPs) in the target regions. Lead placement is targeted to have symmetric CMAPs (i.e. physiologic midline) and adequate coverage of the painful regions as described by Falowski et al.
(Falowski et al., 2011).
|
Outcome Measures
Primary Outcome Measures
- Safety assessed by the number of adverse events [24 weeks]
- Efficacy assessed by the procedure time and number of revision differences between the Awake and Non-Awake methods [24 weeks]
Secondary Outcome Measures
- Pain Evaluation [24 weeks]
- Pain Location [24 weeks]
- Paresthesia assessed by patient reports of tingling, tickling, or prickling sensation [24 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients who have had a successful spinal cord stimulation trial and are indicated for permanent implantation at a participating facility.
-
Sign informed consent
Exclusion Criteria:
- < 18 years of age
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
Sponsors and Collaborators
- St. Luke's Hospital, Pennsylvania
- Abbott Medical Devices
Investigators
- Principal Investigator: Steven Falowski, MD, Principal Investigator
Study Documents (Full-Text)
More Information
Publications
None provided.- 2014-81