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

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ClinicalTrials.gov Identifier: NCT02284542
Recruitment Status : Completed
First Posted : November 6, 2014
Last Update Posted : May 2, 2017
Sponsor:
Collaborator:
Abbott Medical Devices
Information provided by (Responsible Party):
Steven Falowski, MD, St. Luke's Hospital, Pennsylvania

Tracking Information
First Submitted Date October 27, 2014
First Posted Date November 6, 2014
Last Update Posted Date May 2, 2017
Study Start Date November 1, 2014
Actual Primary Completion Date January 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 3, 2014)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 3, 2014)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title NAPS: Non-awake Versus Awake Placement of Spinal Cord Stimulators
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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Chronic Pain
  • Sciatica
  • Failed Back Surgery Syndrome
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.
  • 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).

Study Groups/Cohorts 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.
Interventions:
  • Procedure: Awake
  • Procedure: Non-Awake
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 1, 2017)
34
Original Estimated Enrollment
 (submitted: November 3, 2014)
50
Actual Study Completion Date January 31, 2017
Actual Primary Completion Date January 31, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02284542
Other Study ID Numbers 2014-81
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: SJM and Dr. Falowski will share results upon study completion.
Responsible Party Steven Falowski, MD, St. Luke's Hospital, Pennsylvania
Study Sponsor St. Luke's Hospital, Pennsylvania
Collaborators Abbott Medical Devices
Investigators
Principal Investigator: Steven Falowski, MD Principal Investigator
PRS Account St. Luke's Hospital, Pennsylvania
Verification Date May 2017