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

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.
 
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

Study Description
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Brief Summary:
The objective of this study is to evaluate extent, location, and perception of paresthesia as a function of anode/cathode configuration.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Pain Device: Precision Spinal Cord Stimulation (SCS) Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Optimized Programming in a Multiple-Independent Current Sources Spinal Cord Stimulation (SCS) System
Study Start Date : March 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2009
Arms and Interventions
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Arm Intervention/treatment
Spinal Cord Stimulation Group
Spinal Cord Stimulation (SCS) Treatment Group
 Device: Precision Spinal Cord Stimulation (SCS)
Various SCS device programming parameters
Other Name: Precision Spinal Cord Stimulation System


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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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): NCT00871819


Locations
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United States, California
University of California, San Diego Medical Center
San Diego, California, United States, 92037
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Nicholas Kormylo, MD University of California, San Diego
More Information
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00871819    
Other Study ID Numbers: A2008
First Posted: March 30, 2009    Key Record Dates
Results First Posted: April 4, 2012
Last Update Posted: November 27, 2013
Last Verified: November 2013
Keywords provided by Boston Scientific Corporation:
Spinal Cord Stimulation
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Pain
Neurologic Manifestations