Safety and Effectiveness Study of the Precision SCS Systems Adapted for High-Rate Spinal Cord Stimulation (ACCELERATE)

A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation

To evaluate the safety and effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation as an aid in the management of chronic intractable pain

Study Overview

• Status: Completed
• Conditions: Back Pain; Chronic Pain
• Intervention / Treatment: Device: PRECISION SCS Adapted for High-Rate SCS

Detailed Description

To evaluate the safety and effectiveness of high rate spinal cord stimulation (HR-SCS) therapy as an aid in the management of chronic intractable pain of the trunk using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation

• Study Type: Interventional
• Enrollment (Actual): 383
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • HOPE Research Institute
  • California
    • Carlsbad, California, United States, 92009
      • Coastal Pain & Spinal Diagnostics
    • La Jolla, California, United States, 92037
      • UCSD Medical Center - Jacobs Medical Center
    • San Diego, California, United States, 92111
      • San Diego Pain Institute
  • Florida
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Willis-Knighton River Cities Clinical Research Center
  • Minnesota
    • Edina, Minnesota, United States, 55433
      • MAPS Applied Research Center
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Foundation
  • Missouri
    • Springfield, Missouri, United States, 65804
      • Mercy Medical Research Institute
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • HOPE Research Institute
  • New Jersey
    • Shrewsbury, New Jersey, United States, 07702
      • Premier Pain Centers, LLC
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research, LLC
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Of Cleveland
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Pacific Sports and Spine, LLC
    • Eugene, Oregon, United States, 97401
      • Pain Consultants of Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health Sciences University
    • Springfield, Oregon, United States, 97477
      • Oregon Neurosurgery
  • Texas
    • Tyler, Texas, United States, 75701
      • Precision Spine Care
  • Washington
    • Seattle, Washington, United States, 98104
      • Pacific Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have been diagnosed with chronic, intractable pain of the trunk (NRS ≥ 5) which has been refractory to conservative therapy for a minimum of 90 days.
• Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
• Be 22 years of age or older at the time of enrollment
• Be willing and capable of giving informed consent
• Be willing and able to comply with study-related requirements, procedures, and visits

Exclusion Criteria:

• Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
• Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist
• Have previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
• Have a current systemic infection, or local infection in close proximity to anticipated surgical field
• Pregnant or plan to get pregnant during the course of the study or not using adequate contraception.
• Be participating in another clinical study that may influence the data collected for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Rate Spinal Cord Stimulation; PRECISION SCS Adapted for High-Rate SCS	Device: PRECISION SCS Adapted for High-Rate SCS; Comparison of spinal cord stimulation parameters; Other Names: Boston Scientific PRECISION Spinal Cord Stimulator System
Active Comparator: Commercial Rate Spinal Cord Stimulation; PRECISION SCS Adapted for High-Rate SCS	Device: PRECISION SCS Adapted for High-Rate SCS; Comparison of spinal cord stimulation parameters; Other Names: Boston Scientific PRECISION Spinal Cord Stimulator System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response Rates	Cummulative distribution function (CDF) of response rates from 0% - 100% numerical rating score (NRS) to derive the entire range of possible responder definitions. This allows us to determine the range of success for all responder rates without the need to identify a certain cutoff (for example, use a 50% responder rate). A comparison between the two CDF's was performed by comparing the area under the curves since area between CDFs is equal to the mean difference in low back pain reduction for CR-SCS and HR-SCS. Hence, it can be used to estimate the true underlying difference in responder rates between CR-SCS and HR-SCS	3 months post-activation

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Mark Wallace, M.D., University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2014
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): August 29, 2019

Study Registration Dates

• First Submitted: March 19, 2014
• First Submitted That Met QC Criteria: March 19, 2014
• First Posted (Estimate): March 21, 2014

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: A4007