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

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02093793
• Collaborator: (none)
• Enrollment: 383
• Locations: 20
• Arms: 2
• Actual Duration (Months): 65.1
• Patients Per Site: 19.2
• Patients Per Site Per Month: 0.3

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain; Back Pain	Device: PRECISION SCS Adapted for High-Rate SCS	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 383 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 27, 2014
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Aug 29, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response Rates [3 months post-activation]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hope Research Institute	Phoenix	Arizona	United States	85018
2	Coastal Pain & Spinal Diagnostics	Carlsbad	California	United States	92009
3	UCSD Medical Center - Jacobs Medical Center	La Jolla	California	United States	92037
4	San Diego Pain Institute	San Diego	California	United States	92111
5	Compass Research, LLC	Orlando	Florida	United States	32806
6	Rush University Medical Center	Chicago	Illinois	United States	60612
7	Willis-Knighton River Cities Clinical Research Center	Shreveport	Louisiana	United States	71105
8	MAPS Applied Research Center	Edina	Minnesota	United States	55433
9	Mayo Clinic Foundation	Rochester	Minnesota	United States	55905
10	Mercy Medical Research Institute	Springfield	Missouri	United States	65804
11	Hope Research Institute	Las Vegas	Nevada	United States	89128
12	Premier Pain Centers, LLC	Shrewsbury	New Jersey	United States	07702
13	The Center for Clinical Research, LLC	Winston-Salem	North Carolina	United States	27103
14	University Hospitals of Cleveland	Cleveland	Ohio	United States	44106
15	Pacific Sports and Spine, LLC	Eugene	Oregon	United States	97401
16	Pain Consultants of Oregon	Eugene	Oregon	United States	97401
17	Oregon Health Sciences University	Portland	Oregon	United States	97239
18	Oregon Neurosurgery	Springfield	Oregon	United States	97477
19	Precision Spine Care	Tyler	Texas	United States	75701
20	Pacific Medical Center	Seattle	Washington	United States	98104

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Mark Wallace, M.D., University of California, San Diego

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 6, 2017

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT02093793
• Other Study ID Numbers: A4007
• First Posted: Mar 21, 2014
• Last Update Posted: Nov 13, 2020
• Last Verified: Nov 1, 2020

• Additional relevant MeSH terms: Chronic Pain

Study Results

Participant Flow

Pre-assignment Detail	After subjects were enrolled, they were evaluated per study eligibility criteria. Only those who met all criteria proceeded to receive implant and randomized in the study (as applicable).

Arm/Group Title	High Rate SCS Followed by Commercial SCS	Commercial SCS Settings Followed by High Rate SCS	High Rate Settings Only
Arm/Group Description	High Rate SCS Settings followed by Commercial Settings	Commercial SCS Settings followed by High Rate SCS programming settings	High Rate settings only
Period Title: Overall Study
STARTED	98	90	68
COMPLETED	91	80	65
NOT COMPLETED	7	10	3

Baseline Characteristics

Arm/Group Title	High Rate SCS Followed by Commercial SCS	Commercial SCS Settings Followed by High Rate SCS	High Rate Settings Only	Total
Arm/Group Description	High Rate SCS Settings followed by Commercial Settings	Commercial SCS Settings followed by High Rate SCS programming settings	High Rate settings only	Total of all reporting groups
Overall Participants	98	90	68	256
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.9 (11.6)	53.6 (13.1)	58.5 (11.4)	55.6 (12)
Sex: Female, Male (Count of Participants)
Female	59 60.2%	49 54.4%	27 39.7%	135 52.7%
Male	39 39.8%	41 45.6%	41 60.3%	121 47.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1%	2 2.2%	0 0%	3 1.2%
Asian	1 1%	1 1.1%	1 1.5%	3 1.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	7 7.1%	3 3.3%	7 10.3%	17 6.6%
White	83 84.7%	76 84.4%	57 83.8%	216 84.4%
More than one race	0 0%	2 2.2%	0 0%	2 0.8%
Unknown or Not Reported	6 6.1%	6 6.7%	3 4.4%	15 5.9%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects with a successful trial (High rate settings only) or simulated trial responders (High rate SCS followed by Commercial SCS or vice versa)

Arm/Group Title	Commercial SCS	High Rate SCS	High Rate Settings Only
Arm/Group Description	Commercial SCS (as part of crossover)	High Rate SCS (as part of crossover)	High Rate settings only
Measure Participants	30	38	65
Number [probability]	0.47	0.53	0.4

Adverse Events

Time Frame	All adverse events were collected through end of crossover phase (High Rate SCS followed by Commercial SCS or vice versa group) or up to 3 months post activation (HR settings only group) for subjects who started the study (n = 256)
Adverse Event Reporting Description	All adverse events were collected through end of crossover phase (High Rate SCS followed by Commercial SCS or vice versa group) or up to 3 months post activation (HR settings only group) for subjects who started the study (n = 256)
Arm/Group Title	High Rate SCS		Commercial SCS		High Rate Settings Only
Arm/Group Description	High Rate SCS Settings		Commercial SCS Settings		High Rate settings only
All Cause Mortality
	High Rate SCS		Commercial SCS		High Rate Settings Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/188 (0.5%)		0/188 (0%)		0/68 (0%)
Serious Adverse Events
	High Rate SCS		Commercial SCS		High Rate Settings Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/188 (4.3%)		3/188 (1.6%)		2/68 (2.9%)
Cardiac disorders
Sick Sinus Syndrome	1/188 (0.5%)	1	0/188 (0%)	0	0/68 (0%)	0
Gastrointestinal disorders
Colitis	1/188 (0.5%)	1	0/188 (0%)	0	0/68 (0%)	0
Small Intestinal Obstruction	0/188 (0%)	0	0/188 (0%)	0	0/68 (0%)	0
General disorders
Chest Pain	0/188 (0%)	0	1/188 (0.5%)	1	0/68 (0%)	0
Infections and infestations
Pnuemonia	0/188 (0%)	0	1/188 (0.5%)	1	0/68 (0%)	0
Viral Infection	1/188 (0.5%)	1	0/188 (0%)	0	0/68 (0%)	0
Appendicitis	0/188 (0%)	0	0/188 (0%)	0	0/68 (0%)	0
Clostridium difficile colitis	0/188 (0%)	0	1/188 (0.5%)	1	0/68 (0%)	0
Gastroentritis	1/188 (0.5%)	1	1/188 (0.5%)	1	0/68 (0%)	0
Urinary Tract Infection	0/188 (0%)	0	0/188 (0%)	0	0/68 (0%)	0
Implant Site Infection	0/188 (0%)	0	0/188 (0%)	0	1/68 (1.5%)	1
Injury, poisoning and procedural complications
Hip Fracture	0/188 (0%)	0	0/188 (0%)	0	0/68 (0%)	0
Nervous system disorders
Cerebral Heamorhhage	1/188 (0.5%)	1	0/188 (0%)	0	0/68 (0%)	0
Cerebrovascular accident	0/188 (0%)	0	0/188 (0%)	0	0/68 (0%)	0
Ischemic Stroke	0/188 (0%)	0	0/188 (0%)	0	1/68 (1.5%)	1
Renal and urinary disorders
Chronic Renal Failure	1/188 (0.5%)	1	0/188 (0%)	0	0/68 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure	0/188 (0%)	0	0/188 (0%)	0	0/68 (0%)	0
Chronic Bronchitis	1/188 (0.5%)	1	0/188 (0%)	0	0/68 (0%)	0
Chronic obstructive pulmonary disease	2/188 (1.1%)	2	0/188 (0%)	0	0/68 (0%)	0
Dyspnoea	0/188 (0%)	0	0/188 (0%)	0	0/68 (0%)	0
Chronic obstructive pulmonary disease	0/188 (0%)	0	0/188 (0%)	0	0/68 (0%)	0
Vascular disorders
Hypertension	1/188 (0.5%)	1	0/188 (0%)	0	0/68 (0%)	0
Other (Not Including Serious) Adverse Events
	High Rate SCS		Commercial SCS		High Rate Settings Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/188 (5.9%)		13/188 (6.9%)		4/68 (5.9%)
General disorders
Implant Site Pain	11/188 (5.9%)	12	0/188 (0%)	0	4/68 (5.9%)	4
Musculoskeletal and connective tissue disorders
Back Pain	0/188 (0%)	0	13/188 (6.9%)	13	0/68 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.