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SCS Research Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03763708
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : June 10, 2022
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Study Description
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Brief Summary:
To characterize the effects of stimulation parameters on pain relief and other cohort specific outcomes.

Condition or disease Intervention/treatment Phase
Limb Pain Trunk Pain Device: Spinal Cord Stimulation Phase 4

Detailed Description:

This post market study will measure the following:

  • Numeric Pain Rating Scale
  • Satisfaction and Stimulation Assessment
  • Stimulation feedback
  • Stimulation parameters
  • Anatomical locations of active contacts
  • Stimulation thresholds
  • Location of paresthesia
  • Oswestry Disability Index
  • European Quality of Life 5-Dimensions
  • To characterize non-invasive health monitoring data
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spinal Cord Stimulation Research Study
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : January 2029
Estimated Study Completion Date : January 2029
Arms and Interventions
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Arm Intervention/treatment
Experimental: Spinal Cord Stimulation
Each subject will be programmed to different settings.
 Device: Spinal Cord Stimulation
Programming


Outcome Measures
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Primary Outcome Measures :
  1. Numeric pain rating scale [ Time Frame: Up to 16 months ]
    To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded in clinic or once a day on a multi-day diary, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score from the diary prior to the scheduled visit will be used for analysis.


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 22 years of age or older
  2. Implanted with a Medtronic rechargeable neurostimulation system, for a labeled indication, for at least 1 month and expected longevity of neurostimulator is at least 5 months
  3. Willing and able to provide signed and dated informed consent
  4. Capable of comprehending and consenting in English
  5. Willing and able to comply with all study procedures, including diary completion, and visits
  6. Able to differentiate between pain associated with the indication for SCS implant and other types of pain

Exclusion Criteria:

  1. Implanted with neurostimulation system for an off-label indication
  2. Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results
  3. If female, pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
  4. Has untreated major psychiatric comorbidity
  5. Has a non-rechargeable neurostimulator where the battery longevity is not able to be estimated with the battery longevity calculator
Contacts and Locations
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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): NCT03763708


Contacts
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Contact: SCS Research Clinical Research Study Team 800-633-8766 rs.scsresearch@medtronic.com

Locations
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United States, Arizona
Center for Pain and Supportive Care Recruiting
Phoenix, Arizona, United States, 85028
Contact: Krisstin Hammond       khammond@azcpsc.com   
Contact: Christine Watson       cwatson@azcpsc.com   
Principal Investigator: Gobi Paramanandam, MD         
Sub-Investigator: Jennifer Kiser, PA         
Sub-Investigator: Janis Reinmuth, NP         
United States, California
University of California San Diego Altman Clinical and Translational Research Institute Not yet recruiting
La Jolla, California, United States, 92093
Contact: Lea Jacinto       ljacinto@health.ucsd.edu   
Principal Investigator: Timothy Furnish         
Sub-Investigator: Krishnan Chakravarthy         
United States, Indiana
Goodman Campbell Brain and Spine Recruiting
Carmel, Indiana, United States, 46032
Contact: Stacie Gren    317-396-1354    sgren@goodmancampbell.com   
Principal Investigator: Todd Schmidt, MD         
United States, Kentucky
Drez One Recruiting
Somerset, Kentucky, United States, 42503
Contact: Chelsea Decker       chelsea.decker7@gmail.com   
Principal Investigator: Amr El-Naggar, MD         
United States, Minnesota
Twin Cities Pain Clinic Recruiting
Edina, Minnesota, United States, 55439
Contact: Karen Trutnau    952-204-3090    karen.trutnau@tcpain.com   
Contact: David Kulberg    952-204-3090    David.Kulberg@tcpain.com   
Principal Investigator: Andrew Will, MD         
Sub-Investigator: Karen Trutnau, CNP         
United States, Missouri
Regional Brain and Spine Recruiting
Cape Girardeau, Missouri, United States, 63701
Contact: Hiliary Gooch    573-332-7746 ext 144    hgooch@regionalbrainandspine.com   
Principal Investigator: Christopher Reis, DO         
United States, North Carolina
Carolinas Research Institute Recruiting
Huntersville, North Carolina, United States, 28078
Contact: Alex Stevens       astevens@carolinaspaincenter.com   
Contact: Mandy Glass    704-500-2332 ext 4107    aglass@carolinaspaincenter.com   
Principal Investigator: Binit Shah, MD         
Sub-Investigator: Joanna Wroblewska-Shah, MD         
United States, Pennsylvania
Center for Interventional Pain and Spine Recruiting
Lancaster, Pennsylvania, United States, 17601
Contact: Ashley Scherer    302-750-3099    ashleys@centerisp.com   
Principal Investigator: Michael Fishman, MD         
Sub-Investigator: Steven Falowski, MD         
Sub-Investigator: Philip Kim, MD         
Sub-Investigator: Justin Winas, MD         
Pain Diagnostics and Interventional Care Recruiting
Sewickley, Pennsylvania, United States, 15143
Contact: Jozef Leech    412-221-7640    research@davidprovenzanomd.com   
Principal Investigator: David Provenzano, MD         
Sub-Investigator: L'lee Janicki, PA-C         
United States, Washington
Northwest Pain Care Recruiting
Spokane, Washington, United States, 99201
Contact: Crystal Stevens       cestevens@northwestpaincare.com   
Principal Investigator: John Hatheway, MD         
Sub-Investigator: Lauren Woodward, PA-C         
United States, West Virginia
West Virginia University Completed
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
MedtronicNeuro
More Information
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Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT03763708    
Other Study ID Numbers: MDT18036
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: June 10, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No