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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Rate Spinal Cord Stimulation | Experimental | PRECISION SCS Adapted for High-Rate SCS |
|
| Commercial Rate Spinal Cord Stimulation | Active Comparator | PRECISION SCS Adapted for High-Rate SCS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRECISION SCS Adapted for High-Rate SCS | Device | Comparison of spinal cord stimulation parameters |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Wallace, M.D. | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Research Institute | Phoenix | Arizona | 85018 | United States | ||
| Coastal Pain & Spinal Diagnostics |
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | High Rate SCS Followed by Commercial SCS | High Rate SCS Settings followed by Commercial Settings |
| FG001 | Commercial SCS Settings Followed by High Rate SCS | Commercial SCS Settings followed by High Rate SCS programming settings |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2017 |
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|
| 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 |
| FG002 | High Rate Settings Only | High Rate settings only |
| COMPLETED |
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| NOT COMPLETED |
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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).
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| ID | Title | Description |
|---|---|---|
| BG000 | High Rate SCS Followed by Commercial SCS | High Rate SCS Settings followed by Commercial Settings |
| BG001 | Commercial SCS Settings Followed by High Rate SCS | Commercial SCS Settings followed by High Rate SCS programming settings |
| BG002 | High Rate Settings Only | High Rate settings only |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Subjects with a successful trial (High rate settings only) or simulated trial responders (High rate SCS followed by Commercial SCS or vice versa) | Posted | Number | probability | 3 months post-activation |
|
|
|
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)
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)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Rate SCS | High Rate SCS Settings | 1 | 188 | 8 | 188 | 11 | 188 |
| EG001 | Commercial SCS | Commercial SCS Settings | 0 | 188 | 3 | 188 | 13 | 188 |
| EG002 | High Rate Settings Only | High Rate settings only | 0 | 68 | 2 | 68 | 4 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Pnuemonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Cerebral Heamorhhage | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Chronic Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Sick Sinus Syndrome | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroentritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Chronic Renal Failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Implant Site Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Ischemic Stroke | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant Site Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Sciences | Boston Scientific | 6619494350 | roshini.jain@bsci.com |
| Feb 2, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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