Optimized Programming in Spinal Cord Stimulation (SCS) System

NCT00871819 | Completed Phase 4 Results

• 1 other identifier: A2008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neuropathic Pain; Pain

Keywords

Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Spinal Cord Stimulation Group

OTHER

Spinal Cord Stimulation (SCS) Treatment Group

Device: Precision Spinal Cord Stimulation (SCS)

Interventions

Precision Spinal Cord Stimulation (SCS) DEVICE

Various SCS device programming parameters

Also known as: Precision Spinal Cord Stimulation System

Spinal Cord Stimulation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

University of California, San Diego Medical Center

San Diego, California, 92037, United States

Location

MeSH Terms

Conditions

Neuralgia; Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Small number of subjects; technical outcomes not necessarily predictive of therapeutic effectiveness.

Results Point of Contact

• Title: Nitzan Mekel-Bobrov, Ph.D.
• Organization: Boston Scientific

Nitzan.Mekel-Bobrov@bsci.com

(661) 949-4537

Study Officials

• Nicholas Kormylo, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2009
• First Posted: March 30, 2009
• Study Start: March 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: November 27, 2013
• Results First Posted: April 4, 2012

Record last verified: 2013-11

Locations

US (1)