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

Primary Purpose

Chronic Pain, Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PRECISION SCS Adapted for High-Rate SCS
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hope Research Institute
  • Coastal Pain & Spinal Diagnostics
  • UCSD Medical Center - Jacobs Medical Center
  • San Diego Pain Institute
  • Compass Research, LLC
  • Rush University Medical Center
  • Willis-Knighton River Cities Clinical Research Center
  • MAPS Applied Research Center
  • Mayo Clinic Foundation
  • Mercy Medical Research Institute
  • Hope Research Institute
  • Premier Pain Centers, LLC
  • The Center for Clinical Research, LLC
  • University Hospitals of Cleveland
  • Pacific Sports and Spine, LLC
  • Pain Consultants of Oregon
  • Oregon Health Sciences University
  • Oregon Neurosurgery
  • Precision Spine Care
  • Pacific Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Rate Spinal Cord Stimulation

Commercial Rate Spinal Cord Stimulation

Arm Description

PRECISION SCS Adapted for High-Rate SCS

PRECISION SCS Adapted for High-Rate SCS

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 19, 2014
Last Updated
November 10, 2020
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02093793
Brief Title
Safety and Effectiveness Study of the Precision SCS Systems Adapted for High-Rate Spinal Cord Stimulation
Acronym
ACCELERATE
Official Title
A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 27, 2014 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
August 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
383 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Rate Spinal Cord Stimulation
Arm Type
Experimental
Arm Description
PRECISION SCS Adapted for High-Rate SCS
Arm Title
Commercial Rate Spinal Cord Stimulation
Arm Type
Active Comparator
Arm Description
PRECISION SCS Adapted for High-Rate SCS
Intervention Type
Device
Intervention Name(s)
PRECISION SCS Adapted for High-Rate SCS
Other Intervention Name(s)
Boston Scientific PRECISION Spinal Cord Stimulator System
Intervention Description
Comparison of spinal cord stimulation parameters
Primary Outcome Measure Information:
Title
Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response Rates
Description
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
Time Frame
3 months post-activation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Wallace, M.D.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hope Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Coastal Pain & Spinal Diagnostics
City
Carlsbad
State/Province
California
ZIP/Postal Code
92009
Country
United States
Facility Name
UCSD Medical Center - Jacobs Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
San Diego Pain Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Willis-Knighton River Cities Clinical Research Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
MAPS Applied Research Center
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Mayo Clinic Foundation
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mercy Medical Research Institute
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Hope Research Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Premier Pain Centers, LLC
City
Shrewsbury
State/Province
New Jersey
ZIP/Postal Code
07702
Country
United States
Facility Name
The Center for Clinical Research, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Pacific Sports and Spine, LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Pain Consultants of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Oregon Neurosurgery
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Precision Spine Care
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Pacific Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

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

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