NAPS: Non-awake Versus Awake Placement of Spinal Cord Stimulators

Chronic Pain Clinical Trial

— NAPS  

Official title:

NAPS (Non-awake Versus Awake Placement of Spinal Cord Stimulators) Study for the Evaluation of Awake and Non-awake Methods of SCS Paddle Lead Placement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284542
• Other study ID #: 2014-81
• Status: Completed
• Start date: November 1, 2014
• Est. completion date: January 31, 2017

Study information

• Verified date: October 2021
• Source: St. Luke's Hospital, Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Failed Back Surgery Syndrome
• Sciatica

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	St. Luke's University Health Network	Bethlehem	Pennsylvania
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Penn State Hershey Neurosciences Institute	Hershey	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
St. Luke's Hospital, Pennsylvania	Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessed by the number of adverse events		24 weeks
Primary	Efficacy assessed by the procedure time and number of revision differences between the Awake and Non-Awake methods		24 weeks
Secondary	Pain Evaluation		24 weeks
Secondary	Pain Location		24 weeks
Secondary	Paresthesia assessed by patient reports of tingling, tickling, or prickling sensation		24 weeks