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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02284542
First Posted: November 6, 2014
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
St. Jude Medical
Information provided by (Responsible Party):
Steven Falowski, MD, St. Luke's Hospital, Pennsylvania
  Purpose

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 Intervention
Chronic Pain Sciatica Failed Back Surgery Syndrome Procedure: Awake Procedure: Non-Awake

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
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

Further study details as provided by Steven Falowski, MD, St. Luke's Hospital, Pennsylvania:

Primary Outcome Measures:
  • Safety assessed by the number of adverse events [ Time Frame: 24 weeks ]
  • Efficacy assessed by the procedure time and number of revision differences between the Awake and Non-Awake methods [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Pain Evaluation [ Time Frame: 24 weeks ]
  • Pain Location [ Time Frame: 24 weeks ]
  • Paresthesia assessed by patient reports of tingling, tickling, or prickling sensation [ Time Frame: 24 weeks ]

Enrollment: 34
Study Start Date: November 1, 2014
Study Completion Date: January 31, 2017
Primary Completion Date: January 31, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284542


Locations
United States, Pennsylvania
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States, 18015
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Penn State Hershey Neurosciences Institute
Hershey, Pennsylvania, United States, 17033
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
St. Luke's Hospital, Pennsylvania
St. Jude Medical
Investigators
Principal Investigator: Steven Falowski, MD Principal Investigator
  More Information

Responsible Party: Steven Falowski, MD, Neurosurgeon, St. Luke's Hospital, Pennsylvania
ClinicalTrials.gov Identifier: NCT02284542     History of Changes
Other Study ID Numbers: 2014-81
First Submitted: October 27, 2014
First Posted: November 6, 2014
Last Update Posted: October 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: SJM and Dr. Falowski will share results upon study completion.

Additional relevant MeSH terms:
Chronic Pain
Sciatica
Failed Back Surgery Syndrome
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neuralgia
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Back Pain
Postoperative Complications
Pathologic Processes