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| ID | Type | Description | Link |
|---|---|---|---|
| 90987574 | Other Identifier | Boston Scientific (study protocol number) |
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To demonstrate sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude
To demonstrate sustained clinically significant pain relief in patients when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCS starting with supra-perception | Active Comparator | Precision or Precision Spectra Spinal Cord Stimulator System programmed at supra-perception followed by sub-perception SCS |
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| SCS starting with sub-perception amplitude | Experimental | Precision or Precision Spectra Spinal Cord Stimulator System programmed at sub-perception followed by supra-perception SCS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precision or Precision Spectra Spinal Cord Stimulator System | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline | Proportion of subjects with 50% or greater reduction in overall pain intensity from baseline with supra and sub perception amplitude with no increase in average daily medication intake to treat pain | 90 days post activation |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roshini Jain, M.S. | Boston Scientific Neuromodulation Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MORE Foundation | Phoenix | Arizona | 85023 | United States | ||
| Coastal Pain & Spinal Diagnostics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31265205 | Derived | North J, Loudermilk E, Lee A, Sachdeva H, Kaiafas D, Washabaugh E, Sheth S, Scowcroft J, Mekhail N, Lampert B, Yearwood T, Shaw E, Atallah J, McLeod C, Han J, Yu C, Sedrak M, Lucas R, Trobridge A, Hegarty J, Miller N, Chen L, Jain R. Outcomes of a Multicenter, Prospective, Crossover, Randomized Controlled Trial Evaluating Subperception Spinal Cord Stimulation at </=1.2 kHz in Previously Implanted Subjects. Neuromodulation. 2020 Jan;23(1):102-108. doi: 10.1111/ner.13015. Epub 2019 Jul 2. |
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Enrolled subjects underwent study eligibility to determine if they can continue in the study. Following completion of study eligibility, subjects were randomized to the cross-over phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | SCS Starting With Supra-perception Amplitude | Precision or Precision Spectra Spinal Cord Stimulator System programmed starting with supra-perception followed by sub-perception amplitude. Precision or Precision Spectra Spinal Cord Stimulator System |
| FG001 | SCS Starting With Sub-perception Amplitude |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Carlsbad |
| California |
| 92009 |
| United States |
| Kaiser Foundation Hospital - Redwood City | Redwood City | California | 94063 | United States |
| University of California, Davis Medical Center | Sacramento | California | 95817 | United States |
| Clearwater Pain Management | Clearwater | Florida | 33756 | United States |
| Tallahassee Neurological Clinic, PA | Tallahassee | Florida | 32308 | United States |
| Shepherd Center | Atlanta | Georgia | 30309 | United States |
| Orthopedic Research Foundation | Savannah | Georgia | 31405 | United States |
| American Health Network of Indiana, LLC | Muncie | Indiana | 47304 | United States |
| Forest Health Medical Center | Ypsilanti | Michigan | 48198 | United States |
| Jackson Anesthesia Pain Center, LLC | Jackson | Mississippi | 39202 | United States |
| Comprehensive Pain & Rehabilitation | Pascagoula | Mississippi | 39581 | United States |
| KC Pain Centers | Lee's Summit | Missouri | 64086 | United States |
| Mercy Medical Research Institute | Springfield | Missouri | 65804 | United States |
| Vidant Roanoke - Chowan Hospital Pain Center | Ahoskie | North Carolina | 27910 | United States |
| The Center for Clinical Research, LLC | Winston-Salem | North Carolina | 27103 | United States |
| University of Cincinnati Physicians Company | Cincinnati | Ohio | 45219 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Western Reserve Hospital | Cuyahoga Falls | Ohio | 44223 | United States |
| University of Toledo Medical Center | Toledo | Ohio | 43614 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Florence Neurosurgery and Spine | Florence | South Carolina | 29506 | United States |
| PCPMG Clinical Research Unit, LLC | Greenville | South Carolina | 29621 | United States |
| TBI Clinical Research, L.L.C. | Plano | Texas | 75093 | United States |
| Swedish Medical Center | Seattle | Washington | 98124 | United States |
Precision or Precision Spectra Spinal Cord Stimulator System programmed starting with sub-perception and followed by supra-perception amplitude. Precision or Precision Spectra Spinal Cord Stimulator System |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SCS Starting at Supra-perception Amplitude | Precision or Precision Spectra Spinal Cord Stimulator System programmed starting at supra-perception and followed by sub-perception amplitude. Precision or Precision Spectra Spinal Cord Stimulator System |
| BG001 | SCS Starting at Sub-perception Amplitude | Precision or Precision Spectra Spinal Cord Stimulator System starting at sub-perception and followed by supra-perception amplitude. Precision or Precision Spectra Spinal Cord Stimulator System |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline | Proportion of subjects with 50% or greater reduction in overall pain intensity from baseline with supra and sub perception amplitude with no increase in average daily medication intake to treat pain | Due to the nature of crossover study design, all subjects contributed towards each arm, as reflected in the number of participants. | Posted | Count of Participants | Participants | 90 days post activation |
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Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse events up to end of cross over period - approximately upto 180 days after randomization
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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 | All Study Patients Through End of Randomized Phase | All adverse events reported through end of randomized phase | 0 | 140 | 7 | 140 | 0 | 140 |
| EG001 | SCS With Supra Perception Amplitude | All adverse events during SCS with supra perception amplitude | 0 | 140 | 3 | 140 | 0 | 140 |
| EG002 | SCS With Subperception Amplitude | All adverse events during SCS with supra perception amplitude | 0 | 140 | 4 | 140 | 0 | 140 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDrRA | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDrRA | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDrRA | Systematic Assessment |
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| Diverticular Perforation | Gastrointestinal disorders | MedDrRA | Systematic Assessment |
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| Enterocolitis Heamorrhagic | Gastrointestinal disorders | MedDrRA | Systematic Assessment |
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| Post Procedure Infection | Infections and infestations | MedDrRA | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDrRA | Systematic Assessment |
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Clinical study agreement that restricts PI until official study manuscript is available.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roshini Jain, Director of Clinical Sciences | Boston Scientific | 6619494355 | roshini.jain@bsci.com |
| ID | Term |
|---|---|
| D059350 | Chronic 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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