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
1 other identifier
interventional
383
1 country
20
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Mar 2014
Longer than P75 for not_applicable chronic-pain
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2014
CompletedFirst Posted
Study publicly available on registry
March 21, 2014
CompletedStudy Start
First participant enrolled
March 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2019
CompletedResults Posted
Study results publicly available
July 8, 2020
CompletedNovember 13, 2020
November 1, 2020
4.7 years
March 19, 2014
December 23, 2019
November 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
High Rate Spinal Cord Stimulation
EXPERIMENTALPRECISION SCS Adapted for High-Rate SCS
Commercial Rate Spinal Cord Stimulation
ACTIVE COMPARATORPRECISION SCS Adapted for High-Rate SCS
Interventions
Comparison of spinal cord stimulation parameters
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Hope Research Institute
Phoenix, Arizona, 85018, United States
Coastal Pain & Spinal Diagnostics
Carlsbad, California, 92009, United States
UCSD Medical Center - Jacobs Medical Center
La Jolla, California, 92037, United States
San Diego Pain Institute
San Diego, California, 92111, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Willis-Knighton River Cities Clinical Research Center
Shreveport, Louisiana, 71105, United States
MAPS Applied Research Center
Edina, Minnesota, 55433, United States
Mayo Clinic Foundation
Rochester, Minnesota, 55905, United States
Mercy Medical Research Institute
Springfield, Missouri, 65804, United States
Hope Research Institute
Las Vegas, Nevada, 89128, United States
Premier Pain Centers, LLC
Shrewsbury, New Jersey, 07702, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Pacific Sports and Spine, LLC
Eugene, Oregon, 97401, United States
Pain Consultants of Oregon
Eugene, Oregon, 97401, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Oregon Neurosurgery
Springfield, Oregon, 97477, United States
Precision Spine Care
Tyler, Texas, 75701, United States
Pacific Medical Center
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Sciences
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Wallace, M.D.
University of California, San Diego
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2014
First Posted
March 21, 2014
Study Start
March 27, 2014
Primary Completion
December 1, 2018
Study Completion
August 29, 2019
Last Updated
November 13, 2020
Results First Posted
July 8, 2020
Record last verified: 2020-11