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

NCT02284542 | Completed DMC

• 1 other identifier: 2014-81
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Pain; Sciatica; Failed Back Surgery Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Pain Evaluation

  24 weeks

• Pain Location

  24 weeks

• Paresthesia assessed by patient reports of tingling, tickling, or prickling sensation

  24 weeks

Study Arms (1)

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; Procedure: Non-Awake

Interventions

Awake PROCEDURE

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.

Patients with successful trial implant

Non-Awake PROCEDURE

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).

Patients with successful trial implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who have had a successful spinal cord stimulation trial and are indicated for permanent implantation at a participating facility.
• Sign informed consent

You may not qualify if:

• \< 18 years of age

Sponsors & Collaborators

• St. Luke's Hospital, Pennsylvania: lead
• Abbott Medical Devices: collaborator

Study Sites (4)

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Penn State Hershey Neurosciences Institute

Hershey, Pennsylvania, 17033, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Chronic Pain; Sciatica; Failed Back Surgery Syndrome

Interventions

Wake protein, Drosophila

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Postoperative Complications; Pathologic Processes; Back Pain

Study Officials

• Steven Falowski, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: November 6, 2014
• Study Start: November 1, 2014
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

US (4)