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

• 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: MedtronicNeuro
• Information provided by (Responsible Party): MedtronicNeuro

Tracking Information

• First Submitted Date: November 14, 2017
• First Posted Date: November 17, 2017
• Results First Submitted Date: February 3, 2020
• Results First Posted Date: March 20, 2020
• Last Update Posted Date: November 3, 2020
• Actual Study Start Date: November 30, 2017
• Actual Primary Completion Date: February 4, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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)

Current Secondary Outcome Measures (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 (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: Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Chronic Pain

Intervention

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

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 15, 2017): 175
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 21, 2019
• Actual Primary Completion Date: February 4, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03345472
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: MedtronicNeuro
• Original Responsible Party: Same as current
• Current Study Sponsor: MedtronicNeuro
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Vectors Post Market Clinical Research Study Team; Medtronic Restorative Therapies, Pain Therapy

• PRS Account: MedtronicNeuro
• Verification Date: October 2020