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

November 5, 2013 updated by: Boston Scientific Corporation

Optimized Programming in a Multiple-Independent Current Sources Spinal Cord Stimulation (SCS) System

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92037
        • University of California, San Diego Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Spinal Cord Stimulation Group
Spinal Cord Stimulation (SCS) Treatment Group
Device: Precision Spinal Cord Stimulation (SCS)
Various SCS device programming parameters
Other Names:
  • Precision Spinal Cord Stimulation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Immediately post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

March 27, 2009

First Submitted That Met QC Criteria

March 27, 2009

First Posted (ESTIMATE)

March 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 27, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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