<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03763708</url>
  </required_header>
  <id_info>
    <org_study_id>MDT18036</org_study_id>
    <nct_id>NCT03763708</nct_id>
  </id_info>
  <brief_title>SCS Research Study</brief_title>
  <official_title>Spinal Cord Stimulation Research Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MedtronicNeuro</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MedtronicNeuro</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To characterize the effects of stimulation parameters on pain relief and other cohort&#xD;
      specific outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This post market study will measure the following:&#xD;
&#xD;
        -  Numeric Pain Rating Scale&#xD;
&#xD;
        -  Satisfaction and Stimulation Assessment&#xD;
&#xD;
        -  Stimulation feedback&#xD;
&#xD;
        -  Stimulation parameters&#xD;
&#xD;
        -  Anatomical locations of active contacts&#xD;
&#xD;
        -  Stimulation thresholds&#xD;
&#xD;
        -  Location of paresthesia&#xD;
&#xD;
        -  Oswestry Disability Index&#xD;
&#xD;
        -  European Quality of Life 5-Dimensions&#xD;
&#xD;
        -  To characterize non-invasive health monitoring data&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Anticipated">January 2029</completion_date>
  <primary_completion_date type="Anticipated">January 2029</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numeric pain rating scale</measure>
    <time_frame>Up to 16 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Limb Pain</condition>
  <condition>Trunk Pain</condition>
  <arm_group>
    <arm_group_label>Spinal Cord Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject will be programmed to different settings.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spinal Cord Stimulation</intervention_name>
    <description>Programming</description>
    <arm_group_label>Spinal Cord Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 22 years of age or older&#xD;
&#xD;
          2. Implanted with a Medtronic rechargeable neurostimulation system, for a labeled&#xD;
             indication, for at least 1 month and expected longevity of neurostimulator is at least&#xD;
             5 months&#xD;
&#xD;
          3. Willing and able to provide signed and dated informed consent&#xD;
&#xD;
          4. Capable of comprehending and consenting in English&#xD;
&#xD;
          5. Willing and able to comply with all study procedures, including diary completion, and&#xD;
             visits&#xD;
&#xD;
          6. Able to differentiate between pain associated with the indication for SCS implant and&#xD;
             other types of pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Implanted with neurostimulation system for an off-label indication&#xD;
&#xD;
          2. Currently enrolled or planning to enroll in an interventional clinical study that&#xD;
             could potentially confound the study results&#xD;
&#xD;
          3. If female, pregnant or is of child-bearing potential and unwilling to use a medically&#xD;
             acceptable form of birth control during the study&#xD;
&#xD;
          4. Has untreated major psychiatric comorbidity&#xD;
&#xD;
          5. Has a non-rechargeable neurostimulator where the battery longevity is not able to be&#xD;
             estimated with the battery longevity calculator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Center for Pain and Supportive Care</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Goodman Campbell Brain and Spine</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drez One</name>
      <address>
        <city>Somerset</city>
        <state>Kentucky</state>
        <zip>42503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Twin Cities Pain Clinic</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55439</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Brain and Spine</name>
      <address>
        <city>Cape Girardeau</city>
        <state>Missouri</state>
        <zip>63701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Research Institute</name>
      <address>
        <city>Huntersville</city>
        <state>North Carolina</state>
        <zip>28078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Interventional Pain and Spine</name>
      <address>
        <city>Lancaster</city>
        <state>Pennsylvania</state>
        <zip>17601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pain Diagnostics and Interventional Care</name>
      <address>
        <city>Sewickley</city>
        <state>Pennsylvania</state>
        <zip>15143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Pain Care</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>June 20, 2023</last_update_submitted>
  <last_update_submitted_qc>June 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03763708
org study id: MDT18036
nct id: NCT03763708
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
To characterize the effects of stimulation parameters on pain relief and other cohort
      specific outcomes.
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
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Numeric pain rating scale
time frame: Up to 16 months
description: 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.
arm group label: Spinal Cord Stimulation
arm group type: Experimental
description: Each subject will be programmed to different settings.
intervention type: Device
intervention name: Spinal Cord Stimulation
description: Programming
arm group label: Spinal Cord Stimulation
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No