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This is a prospective, single-arm, multi-center study evaluating the efficacy of spinal cord stimulation (SCS) therapy for pain relief using high dose (HD) stimulation parameters delivered to neural targets identified during current commercial trial stimulation procedures. The study will evaluate changes in back and leg pain from baseline to 3, 6, and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated | Experimental | Enrolled subjects who are implanted with a spinal cord stimulation system that is activated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulation System | Device | Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Overall Pain Intensity on the Visual Analog Scale (0-100) | Demonstrate a significant improvement in overall pain intensity as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The change in overall pain intensity is calculated as the Baseline VAS minus the 3-month VAS, where a positive value indicates an improvement (ie, reduction) in pain from Baseline to 3 months. Higher values represent a larger reduction (ie, greater improvement) in pain. The change in overall pain intensity as measured by the VAS can range from -100 (worsening in pain from 0 at baseline to 100 at 3 months) to 100 (improvement in pain from 100 at baseline to 0 at 3 months). It should be noted that while the change in VAS can range from -100 to 100, no subjects had a VAS of 0 at baseline, as the presence of pain was required for eligibility for inclusion in the study. | Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Pain Efficacy Responder Rate | Characterize the overall pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in overall pain, as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as [100*(Baseline VAS - 3-month VAS)/Baseline VAS], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder. The percentage of subjects who experience at least a 50% improvement in overall pain can range from 0% (no responders) to 100% (all responders). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vectors Post Market Clinical Research Study Team | Medtronic Restorative Therapies, Pain Therapy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain Consultants of San Diego | La Mesa | California | 91942-8901 | United States | ||
| Restore Orthopedics and Spine Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33296127 | Derived | Hatheway JA, Mangal V, Fishman MA, Kim P, Shah B, Vogel R, Galan V, Severyn S, Weaver TE, Provenzano DA, Chang E, Verdolin MH, Howes G, Villarreal A, Falowski S, Hendrickson K, Stromberg K, Davies L, Johanek L, Kelly MT. Long-Term Efficacy of a Novel Spinal Cord Stimulation Clinical Workflow Using Kilohertz Stimulation: Twelve-Month Results From the Vectors Study. Neuromodulation. 2021 Apr;24(3):556-565. doi: 10.1111/ner.13324. Epub 2020 Dec 9. |
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175 subjects were enrolled. 32 exited before the spinal cord stimulation trial. 143 subjects started the trial and 12 exited during the trial. 131 subjects completed the trial: 117 had a successful high dose (HD) trial; the 14 with unsuccessful HD trial were exited. Of the 117, 14 exited before implant and 103 were implanted (Treated Arm).
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| ID | Title | Description |
|---|---|---|
| FG000 | Treated | Enrolled subjects who are implanted with a spinal cord stimulation system that is activated. Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Implant to 3 Months |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2018 | Feb 3, 2020 |
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| Baseline to 3 months |
| Low Back Pain Efficacy Responder Rate | Characterize the low back pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in low back pain, as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as [100*(Baseline VAS - 3-month VAS)/Baseline VAS], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder. The percentage of subjects who experience at least a 50% improvement in low back pain can range from 0% (no responders) to 100% (all responders). | Baseline to 3 months |
| Leg Pain Efficacy Responder Rate | Characterize the leg pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in leg pain, as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as [100*(Baseline VAS - 3-month VAS)/Baseline VAS], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder. The percentage of subjects who experience at least a 50% improvement in leg pain can range from 0% (no responders) to 100% (all responders). | Baseline to 3 months |
| Orange |
| California |
| 92868 |
| United States |
| Center for Interventional Pain and Spine | Wilmington | Delaware | 19803 | United States |
| Pain Care | Stockbridge | Georgia | 30281-5023 | United States |
| National Spine and Pain | Oxon Hill | Maryland | 20745 | United States |
| Michigan Pain Consultants | Wyoming | Michigan | 49519 | United States |
| Comprehensive and Interventional Pain Management | Henderson | Nevada | 89052 | United States |
| The Pain Management Center | Voorhees Township | New Jersey | 08043-3512 | United States |
| University of Rochester Neurosurgery Partners Pain Management | Rochester | New York | 14618 | United States |
| Carolinas Pain Center | Huntersville | North Carolina | 28078 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Lehigh Valley Healthcare Network | Allentown | Pennsylvania | 18103 | United States |
| Saint Luke's Neurosurgical Associates | Bethlehem | Pennsylvania | 18015 | United States |
| Pain Diagnostics and Interventional Care | Sewickley | Pennsylvania | 15134 | United States |
| Delaware Valley Pain and Spine Institute | Trevose | Pennsylvania | 19053 | United States |
| Lowcountry Orthopaedics/Coastal Carolina Research Center | Charleston | South Carolina | 29406 | United States |
| Carolina Center for Advanced Management of Pain | Spartanburg | South Carolina | 29303 | United States |
| Precision Spine Care | Tyler | Texas | 75701 | United States |
| Carilion Clinic Roanoke Memorial Hospital | Roanoke | Virginia | 24014 | United States |
| Northwest Pain Care | Spokane | Washington | 99201 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
| 3 Months to 12 Months |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treated | Enrolled subjects who are implanted with a spinal cord stimulation system that is activated. Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters. |
| 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Years from pain onset to enrollment | Mean | Standard Deviation | years |
|
| 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 | Change in Overall Pain Intensity on the Visual Analog Scale (0-100) | Demonstrate a significant improvement in overall pain intensity as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The change in overall pain intensity is calculated as the Baseline VAS minus the 3-month VAS, where a positive value indicates an improvement (ie, reduction) in pain from Baseline to 3 months. Higher values represent a larger reduction (ie, greater improvement) in pain. The change in overall pain intensity as measured by the VAS can range from -100 (worsening in pain from 0 at baseline to 100 at 3 months) to 100 (improvement in pain from 100 at baseline to 0 at 3 months). It should be noted that while the change in VAS can range from -100 to 100, no subjects had a VAS of 0 at baseline, as the presence of pain was required for eligibility for inclusion in the study. | Posted | Mean | Standard Error | units on a scale | Baseline to 3 months |
|
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| Secondary | Overall Pain Efficacy Responder Rate | Characterize the overall pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in overall pain, as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as [100*(Baseline VAS - 3-month VAS)/Baseline VAS], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder. The percentage of subjects who experience at least a 50% improvement in overall pain can range from 0% (no responders) to 100% (all responders). | Posted | Number | 95% Confidence Interval | percent of subjects who are responder | Baseline to 3 months |
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| Secondary | Low Back Pain Efficacy Responder Rate | Characterize the low back pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in low back pain, as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as [100*(Baseline VAS - 3-month VAS)/Baseline VAS], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder. The percentage of subjects who experience at least a 50% improvement in low back pain can range from 0% (no responders) to 100% (all responders). | Posted | Number | 95% Confidence Interval | percent of subjects who are responders | Baseline to 3 months |
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| Secondary | Leg Pain Efficacy Responder Rate | Characterize the leg pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in leg pain, as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as [100*(Baseline VAS - 3-month VAS)/Baseline VAS], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder. The percentage of subjects who experience at least a 50% improvement in leg pain can range from 0% (no responders) to 100% (all responders). | Posted | Number | 95% Confidence Interval | percent of subjects who are responders | Baseline to 3 months |
|
|
12 months post-device activation
Adverse events related to the implanted spinal cord stimulation system, accessories, surgical procedures, and therapy were collected.
The sum of subjects affected within each individual event may not add to the total number of subjects affected, as subjects may have experienced more than 1 type of event.
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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 | Treated | Enrolled subjects who are implanted with a spinal cord stimulation system that is activated. Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters. | 1 | 103 | 1 | 103 | 36 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paraesthesia | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Device stimulation issue | Product Issues | MedDRA (22.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
Per the Clinical Investigation Plan, all proposed publications must be reviewed and approved by Medtronic prior to publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stacie Hallaway/Senior Clinical Research Specialist | Medtronic Restorative Therapies Group, Spinal Cord Stimulation | 763-526-3844 | RS.VectorsPM@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 21, 2018 | Feb 3, 2020 | SAP_001.pdf |
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| 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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| Adverse Event |
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| Death |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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