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NCT Number: NCT02284542

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

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.

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Key information

Conditions

Chronic Pain Back Pain Failed Back Surgery Syndrome Mononeuropathies Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Postoperative Complications Sciatic Neuropathy Sciatica Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Luke's University Health Network, Bethlehem, Pennsylvania, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

  1. Safety assessed by the number of adverse events

    Time frame: 24 weeks

  2. Efficacy assessed by the procedure time and number of revision differences between the Awake and Non-Awake methods

    Time frame: 24 weeks

Secondary outcomes

  1. Pain Evaluation

    Time frame: 24 weeks

  2. Pain Location

    Time frame: 24 weeks

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

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

St. Luke's Hospital, Pennsylvania

Other

Collaborators

  • Abbott Medical Devices

Registry information

Official study 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

Acronym: NAPS

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 6, 2014
Registry last updated
Oct 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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