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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Sciatica; Failed Back Surgery Syndrome
• Intervention / Treatment: Procedure: Awake; Procedure: Non-Awake

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's University Health Network
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Neurosciences Institute
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Pain Evaluation	24 weeks
Pain Location	24 weeks
Paresthesia assessed by patient reports of tingling, tickling, or prickling sensation	24 weeks

Collaborators and Investigators

• Sponsor: St. Luke's Hospital, Pennsylvania
• Collaborators: Abbott Medical Devices
• Investigators: Principal Investigator: Steven Falowski, MD, Principal Investigator

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): January 31, 2017
• Study Completion (Actual): January 31, 2017

Study Registration Dates

• First Submitted: October 27, 2014
• First Submitted That Met QC Criteria: November 3, 2014
• First Posted (Estimate): November 6, 2014

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neuromuscular Diseases; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuralgia; Back Pain; Sciatica; Chronic Pain; Failed Back Surgery Syndrome
• Other Study ID Numbers: 2014-81

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: SJM and Dr. Falowski will share results upon study completion.