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

• 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: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

Tracking Information

• First Submitted Date: March 27, 2009
• First Posted Date: March 30, 2009
• Results First Submitted Date: February 13, 2012
• Results First Posted Date: April 4, 2012
• Last Update Posted Date: November 27, 2013
• Study Start Date: March 2009
• Actual Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (submitted: March 27, 2009): Correlation between dorsal root paresthesia at maximum-comfortable stimulation level and anode-cathode separation distance [ Time Frame: Day One ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (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: Optimized Programming in Spinal Cord Stimulation (SCS) System
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Supportive Care

Condition

• Neuropathic Pain
• Pain

Intervention

Device: Precision Spinal Cord Stimulation (SCS)

Various SCS device programming parameters

Other Name: Precision Spinal Cord Stimulation System

Study Arms

Spinal Cord Stimulation Group

Spinal Cord Stimulation (SCS) Treatment Group

Intervention: Device: Precision Spinal Cord Stimulation (SCS)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 27, 2009): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 2009
• Actual Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00871819
• Other Study ID Numbers: A2008
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Boston Scientific Corporation
• Study Sponsor: Boston Scientific Corporation
• Collaborators: Not Provided

Investigators

• Principal Investigator: Nicholas Kormylo, MD; University of California, San Diego

• PRS Account: Boston Scientific Corporation
• Verification Date: November 2013