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Optimized Programming in Spinal Cord Stimulation (SCS) System (OP)

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ClinicalTrials.gov Identifier: NCT00871819
Recruitment Status : Completed
First Posted : March 30, 2009
Results First Posted : April 4, 2012
Last Update Posted : November 27, 2013
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE March 27, 2009
First Posted Date  ICMJE March 30, 2009
Results First Submitted Date  ICMJE February 13, 2012
Results First Posted Date  ICMJE April 4, 2012
Last Update Posted Date November 27, 2013
Study Start Date  ICMJE March 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2012)
Correlation Coefficient Between Dorsal Root Paresthesia (Total Pixels Derived From Digital Drawing) at Maximum-comfortable Stimulation Level and Anode-cathode Separation Distance (mm) [ Time Frame: Immediately post-procedure ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2009)
Correlation between dorsal root paresthesia at maximum-comfortable stimulation level and anode-cathode separation distance [ Time Frame: Day One ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2009)
Location of dorsal root paresthesia under multipolar stimulation vs. traditional contact combinations [ Time Frame: Day One ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimized Programming in Spinal Cord Stimulation (SCS) System
Official Title  ICMJE Optimized Programming in a Multiple-Independent Current Sources Spinal Cord Stimulation (SCS) System
Brief Summary The objective of this study is to evaluate extent, location, and perception of paresthesia as a function of anode/cathode configuration.
Detailed Description The clinical results from this study may help to validate predictions made by mathematical models of neurons that are activated by SCS and increase scientific knowledge about the way in which different programs relate to satisfactory outcomes, such that use of the model may help in the development of new products.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Neuropathic Pain
  • Pain
Intervention  ICMJE Device: Precision Spinal Cord Stimulation (SCS)
Various SCS device programming parameters
Other Name: Precision Spinal Cord Stimulation System
Study Arms  ICMJE Spinal Cord Stimulation Group
Spinal Cord Stimulation (SCS) Treatment Group
Intervention: Device: Precision Spinal Cord Stimulation (SCS)
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2009)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Be previously implanted with Precision SCS System (3-36 months post permanent implant) having 2 parallel percutaneous leads placed between T8-T10.
  • Be implanted with Precision SCS System for the treatment of neuropathic pain of trunk and/or limbs
  • Be 18 years of age or older
  • Be extremely satisfied, very satisfied, or satisfied with SCS therapy for treatment of pain condition
  • Be able to use pen tablet to document regions of paresthesia and pain
  • Be able to lie in the supine position for 45 minutes at a minimum
  • Be able to verbally report qualitative and quantitative aspects of paresthesia sensations.
  • Have a paresthesia threshold on a standard program below 4mA while in the supine position
  • Have at minimum the upper contact of one lead below T8 and the lower contact above T11 vertebral levels
  • Be willing and able to comply with study-related procedure
  • Agree to study requirements and provides written Informed Consent

Exclusion Criteria:

  • Unable to read, write, speak, and understand English
  • Currently pregnant or planning to become pregnant during the course of the study
  • Have negative finding in any of the pre-screening and screening requirements
  • Upon fluoroscopy, location of both leads is identified to be outside T8-T10 vertebral levels
  • Unable to perceive the sensation of paresthesia associated with stimulation in the trunk and/or lower extremities
  • Have a drug pump and/or a non-Precision neurostimulation device (regardless of whether active or inactive)
  • Have had any interventional pain procedure or surgeries (including Interlaminar epidural steroid injection, Transforaminal epidural steroid injection, Caudal epidural steroid injection, Selective nerve root block, Intraarticular lumbar facet injection, Sacroiliac joint injection, Piriformis muscle injection, Trochanteric bursa injection, Hip/knee joint injections, Medial branch block (innervates facet joint), Pulsed radiofrequency neurotomy medial branches, Pulsed radiofrequency dorsal root ganglion, Thermal (high temperature) radiofrequency neurotomy medial branches, Trigger point injections, and Botulinum toxin injections) involving the spine within the past 30 days
  • Have any condition that is likely to confound evaluation of study endpoints. Conditions that may make paresthesia coverage variable over the course of the study include multiple sclerosis, partial spinal cord injury, diabetic peripheral neuropathy, peripheral vascular disease, scoliosis, deafferentation, etc.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00871819
Other Study ID Numbers  ICMJE A2008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nicholas Kormylo, MD University of California, San Diego
PRS Account Boston Scientific Corporation
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP