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Trial record 1 of 13 for:    Medtronic Vectors
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Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation

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ClinicalTrials.gov Identifier: NCT03345472
Recruitment Status : Completed
First Posted : November 17, 2017
Results First Posted : March 20, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Tracking Information
First Submitted Date  ICMJE November 14, 2017
First Posted Date  ICMJE November 17, 2017
Results First Submitted Date  ICMJE February 3, 2020
Results First Posted Date  ICMJE March 20, 2020
Last Update Posted Date November 3, 2020
Actual Study Start Date  ICMJE November 30, 2017
Actual Primary Completion Date February 4, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2020)
Change in Overall Pain Intensity on the Visual Analog Scale (0-100) [ Time Frame: Baseline to 3 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 15, 2017)
Change in overall pain intensity on the Visual Analog Scale (0-100) [ Time Frame: Baseline to 3 months ]
Demonstrate a significant improvement in overall pain intensity as measured by the Visual Analog Scale (VAS)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2020)
  • Overall Pain Efficacy Responder Rate [ Time Frame: Baseline to 3 months ]
    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).
  • Low Back Pain Efficacy Responder Rate [ Time Frame: Baseline to 3 months ]
    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).
  • Leg Pain Efficacy Responder Rate [ Time Frame: Baseline to 3 months ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2017)
  • Overall pain efficacy responder rate [ Time Frame: Baseline to 3 months ]
    Characterize the overall pain efficacy responder rate, where the responder rate is the proportion of subjects who experience at least a 50% improvement in overall pain, as measured by the VAS
  • Low back pain efficacy responder rate [ Time Frame: Baseline to 3 months ]
    Characterize the low back pain efficacy responder rate, where the responder rate is the proportion of subjects who experience at least a 50% improvement in low back pain, as measured by the VAS
  • Leg pain efficacy responder rate [ Time Frame: Baseline to 3 months ]
    Characterize the leg pain efficacy responder rate, where the responder rate is the proportion of subjects who experience at least a 50% improvement in leg pain, as measured by the VAS
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation
Official Title  ICMJE Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation (SCS) With High Dose (HD) Stimulation Parameters
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE Device: Spinal Cord Stimulation System
Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
Other Names:
  • Medtronic RestoreSensor SureScan MRI neurostimulation system
  • Medtronic Intellis AdaptiveStim neurostimulation system
Study Arms  ICMJE Experimental: Treated
Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.
Intervention: Device: Spinal Cord Stimulation System
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2017)
175
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 21, 2019
Actual Primary Completion Date February 4, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Candidate per labeling for an SCS system as an aid in the management of chronic, intractable low back and leg pain
  • Presence of low back and leg pain
  • Moderate to crippled disability due to pain
  • Stable pain medications for back and leg pain for at least 28 days prior to enrollment
  • Willing and able to not increase pain medications through the 3-Month visit

Exclusion Criteria:

  • Previously trialed or implanted with stimulator or intrathecal drug delivery system
  • Current diagnosis of moderate to severe central lumbar spinal stenosis
  • Major psychiatric comorbidity or other progressive diseases
  • Serious drug-related behavioral issues
  • Pregnant or planning on becoming pregnant
  • Unable to achieve supine position
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03345472
Other Study ID Numbers  ICMJE MDT17053
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MedtronicNeuro
Study Sponsor  ICMJE MedtronicNeuro
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Vectors Post Market Clinical Research Study Team Medtronic Restorative Therapies, Pain Therapy
PRS Account MedtronicNeuro
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP