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Optimized Programming in Spinal Cord Stimulation (SCS) System

NCT ID: NCT00871819

Last Updated: 2013-11-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Neuropathic Pain Pain

Keywords

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Spinal Cord Stimulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Spinal Cord Stimulation Group

Spinal Cord Stimulation (SCS) Treatment Group

Group Type OTHER

Precision Spinal Cord Stimulation (SCS)

Intervention Type DEVICE

Various SCS device programming parameters

Interventions

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Precision Spinal Cord Stimulation (SCS)

Various SCS device programming parameters

Intervention Type DEVICE

Other Intervention Names

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Precision Spinal Cord Stimulation System

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicholas Kormylo, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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University of California, San Diego Medical Center

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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A2008

Identifier Type: -

Identifier Source: org_study_id