Optimized Programming in Spinal Cord Stimulation (SCS) System

Pain Clinical Trial

— OP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00871819
• Other study ID #: A2008
• Status: Completed
• Phase: Phase 4
• First received: March 27, 2009
• Last updated: November 5, 2013
• Start date: March 2009
• Est. completion date: September 2009

Study information

• Verified date: November 2013
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Pain

Intervention

Device:
• Precision Spinal Cord Stimulation (SCS)
Various SCS device programming parameters

Locations

Country	Name	City	State
United States	University of California, San Diego Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation Coefficient Between Dorsal Root Paresthesia (Total Pixels Derived From Digital Drawing) at Maximum-comfortable Stimulation Level and Anode-cathode Separation Distance (mm)		Immediately post-procedure	No