Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 13 for:    Medtronic Vectors
Previous Study | Return to List | Next Study

Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Device: Spinal Cord Stimulation System Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation (SCS) With High Dose (HD) Stimulation Parameters
Actual Study Start Date : November 30, 2017
Actual Primary Completion Date : February 4, 2019
Actual Study Completion Date : October 21, 2019

Arm Intervention/treatment
Experimental: Treated
Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.
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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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).


  2. 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).


  3. 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).




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345472


Locations
Show Show 20 study locations
Sponsors and Collaborators
MedtronicNeuro
Investigators
Layout table for investigator information
Study Director: Vectors Post Market Clinical Research Study Team Medtronic Restorative Therapies, Pain Therapy
  Study Documents (Full-Text)

Documents provided by MedtronicNeuro:
Study Protocol  [PDF] May 8, 2018
Statistical Analysis Plan  [PDF] June 21, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT03345472    
Other Study ID Numbers: MDT17053
First Posted: November 17, 2017    Key Record Dates
Results First Posted: March 20, 2020
Last Update Posted: November 3, 2020
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations