<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/NCT03769675</url>
  </required_header>
  <id_info>
    <org_study_id>17-004317</org_study_id>
    <nct_id>NCT03769675</nct_id>
  </id_info>
  <brief_title>Quantitative Assessment of Painful Diabetic Peripheral Neuropathy After High Frequency Spinal Cord Stimulation</brief_title>
  <official_title>Quantitative Assessment of Painful Diabetic Peripheral Neuropathy After High Frequency Spinal Cord Stimulation: (QUANT) HF10 Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      Will participants with painful lower extremity diabetic peripheral neuropathy (DPN) that are&#xD;
      treated with high frequency spinal cord stimulation (HF10 SCS) have improvements in lower&#xD;
      extremity peripheral nerve function?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research study is being conducted to find out if spinal cord stimulation (SCS) can&#xD;
      improve nerve function. SCS is FDA approved for the treatment of intractable neuropathic&#xD;
      (nerve) pain related to diabetic peripheral neuropathy. With SCS a wire is placed in the&#xD;
      epidural space and the spinal cord is stimulated to interrupt the pain signal coming from the&#xD;
      legs. The spinal cord stimulator is a device similar to a pacemaker (which helps treat&#xD;
      abnormal rhythms of the heart). Recent studies have suggested that SCS with high frequencies&#xD;
      can improve nerve function for subjects with painful peripheral neuropathy therefore, the&#xD;
      investigators are looking to measure changes in nerve function after SCS for treatment of&#xD;
      painful diabetic peripheral neuropathy.&#xD;
&#xD;
      The purpose of this research is to gather information on the effect of high frequency spinal&#xD;
      cord stimulation (HF10) on nerve function with a spinal cord stimulator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2018</start_date>
  <completion_date type="Actual">April 15, 2022</completion_date>
  <primary_completion_date type="Actual">April 15, 2022</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>Pain Assessment</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Pain measurement using a Visual Analog Pain Scale by placing an X in the box to indicate the severity of pain from no pain to intolerable pain. The X in the box translates to a score of zero for no pain and increases by an additional 0.5 up to a high score of 10 which would be intolerable pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neuropathy Symptoms and Change (NSC) Score</measure>
    <time_frame>baseline, 12 months</time_frame>
    <description>Validated questionnaire that evaluates change in neuropathy symptoms, including symptoms of weakness, sensory symptoms, and autonomic symptoms. Answers to questionnaire are yes/no and if yes, then degree of severity is evaluated with a plus one(slight), plus two (moderate) and plus three (severe). Questionnaire screens the presence and severity of diabetic peripheral neuropathy. Change in severity of symptoms are compared over time. Total scores range from 0 - 114, lower scores reflect no neuropathy symptoms, higher scores reflect more neuropathy symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oswestry Disability Index</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Questionnaire examines perceived level of disability in 10 everyday activities of daily living including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling. The 6 statements are scored from 0 to 5 scale, zero meaning no disability. The final score ranges from 0-100 with a score of 0-20 equals minimal disability, 21-40 equals moderate disability, 41-60 equals severe disability, 61-80 equals crippled and 81-100 equals bed-bound.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neuropathy Impairment Score (NIS)</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Subject's scores neuropathic deficits using a scale of 0-4 (zero=normal, 4=paralysis) to measure muscle weakness. The NIS score is a measure of neurologic impairment. The NIS Score has a range of 0 to 244. Lower scores indicate higher function, higher scores indicate lower function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lower Limb Function Test</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Test for lower limb function in which the subject will need to walk on toes, walk on heels, and arise from kneeled position, each test is marked as not applicable, normal or abnormal. The examination assesses each component for the left and right side separately. If the test is normal, it is given a score of 0, and if it is abnormal, a score of 1. Not applicable scores a zero. Total scores range 0-6. Therefore, the maximum score of 6 indicates abnormality in all 3 components bilaterally and a minimum score of 0 indicates a normal result for all 3 components bilaterally.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Leads Assessment of Neuropathic Symptoms and Signs</measure>
    <time_frame>baseline, 12 months</time_frame>
    <description>Questionnaire to identify and analyze pain by answering yes/no which translates to scores from 0-24. A score of 12 or more suggests pain of predominantly neuropathic origin.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive Pain</measure>
    <time_frame>baseline, 12 months</time_frame>
    <description>Numeric Rating Scale used to assess pain from a scale of 0 (no pain) to 10 (worst possible pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Screens for the presence and severity of depression with 9 questions in a scale of 0-3. Zero=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Total score range 0 - 27. A total score of 0-4=minimal depression, 5-9=mild depression, 10-14=moderate depression, 15-19=moderately severe depression, 20-27=severe depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Subjects calculated height in centimeters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Subjects calculated weight in kilograms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Subject's BMI calculated as weight in kilograms divided by height in meters squared. Uses measurements of height and weight obtained during study (with appropriate metric conversions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1c</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Reported as percentage of glycated hemoglobin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forearm Sweat Volume Quantitative Axon Reflex Sweat Test (Q-SWEAT)</measure>
    <time_frame>baseline, 12 months</time_frame>
    <description>Test that measures the rate and volume of sweat to determine the severity and pattern of autonomic disorders. As measured by µL/cm²</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proximal Leg Laser Doppler Flowmetry (LDF)</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Laser Doppler velocimetry is used in hemodynamics research as a technique to partially quantify blood flow in human tissues such as skin. Within the clinical environment, the technology is often referred to as laser Doppler flowmetry (LDF). As measured in perfusion units (p.u.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extensor Digitorum Brevis Muscle Nerve Conduction</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>A nerve conduction study (NCS) is a medical diagnostic test commonly used to evaluate the function, especially the ability of electrical conduction, of the motor and sensory nerves of the human body. As measured by amplitude (AMP) milliamp (mA)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Painful Diabetic Neuropathy</condition>
  <arm_group>
    <arm_group_label>Spinal Cord Stimulator Implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spinal Cord Stimulator implant</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High Frequency Spinal Cord Stimulator</intervention_name>
    <description>The SCS implant will follow standard clinical practice for these FDA approved indications. Two percutaneous leads will be placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator (trial phase) or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing will be performed to ensure electrical integrity. Patients with HF10 SCS will receive 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming will occur postoperatively and as needed based on patient feedback in standard clinic visits. .</description>
    <arm_group_label>Spinal Cord Stimulator Implant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes mellitus&#xD;
&#xD;
          -  Refractory predominantly lower extremity neuropathic pain for &gt; 1 year&#xD;
&#xD;
          -  Presence of length dependent peripheral neuropathy on sudomotor testing&#xD;
&#xD;
          -  Completed spinal cord stimulation trial with 40% or greater pain reduction from&#xD;
             baseline&#xD;
&#xD;
          -  Failed medication trials or contraindication to gabapentin medications (gabapentin,&#xD;
             pregabalin) and/or serotonin/norepinephrine reuptake inhibitors (tricyclic&#xD;
             antidepressant (TCA) or duloxetine or venlafaxine)&#xD;
&#xD;
          -  Average pain score on a visual analog scale (VAS) of ≥ 5 (with 0 representing no pain&#xD;
             and 10 the worst pain imaginable)&#xD;
&#xD;
          -  Appropriate surgical candidate for spinal cord stimulator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe Autonomic Neuropathy as measured by the composite autonomic scoring scale (10&#xD;
             point scale) with a score ≥ 7&#xD;
&#xD;
          -  History of sympathectomy&#xD;
&#xD;
          -  Uncontrolled arterial hypertension (Systolic Blood Pressure &gt;160)&#xD;
&#xD;
          -  Baseline Foot TcPO2 &lt; 10 mmHg to exclude patients with severe peripheral arterial&#xD;
             disease&#xD;
&#xD;
          -  Hemoglobin A1c &gt; 8%&#xD;
&#xD;
          -  Stable opioid regimen with oral morphine equivalent ≥ 100 mg/day&#xD;
&#xD;
          -  Alternative principle cause for peripheral neuropathy or lower extremity neuropathic&#xD;
             pain&#xD;
&#xD;
          -  Disruptive psychiatric disorder (screened for during preoperative psychiatric&#xD;
             evaluation)&#xD;
&#xD;
          -  Pending litigations&#xD;
&#xD;
          -  Women of child bearing potential unwilling to use contraception or found to be&#xD;
             pregnant as part of perioperative screening&#xD;
&#xD;
          -  Patients unable to hold medications that would impact autonomic testing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Narayan R Kissoon</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <results_first_submitted>March 16, 2023</results_first_submitted>
  <results_first_submitted_qc>April 10, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 11, 2023</results_first_posted>
  <last_update_submitted>April 10, 2023</last_update_submitted>
  <last_update_submitted_qc>April 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Narayan R. Kissoon</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>spinal cord stimulation</keyword>
  <keyword>type 2 diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Diabetic Neuropathies</mesh_term>
    <mesh_term>Pain</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03769675/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Spinal Cord Stimulator Implant (SCS)</title>
          <description>Spinal Cord Stimulator implant&#xD;
High Frequency Spinal Cord Stimulator: The SCS implant followed standard clinical practice for FDA approved indications: Two percutaneous leads were placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing was performed to ensure electrical integrity. Patients with HF10 SCS received 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming occurred postoperatively and as needed based on patient feedback in standard clinic visits.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Spinal Cord Stimulator Implant (SCS)</title>
          <description>Spinal Cord Stimulator implant&#xD;
High Frequency Spinal Cord Stimulator: The SCS implant followed standard clinical practice for FDA approved indications: Two percutaneous leads were placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing was performed to ensure electrical integrity. Patients with HF10 SCS received 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming occurred postoperatively and as needed based on patient feedback in standard clinic visits.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.0" lower_limit="48.0" upper_limit="61.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Female</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>F-Transgender</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain Assessment</title>
        <description>Pain measurement using a Visual Analog Pain Scale by placing an X in the box to indicate the severity of pain from no pain to intolerable pain. The X in the box translates to a score of zero for no pain and increases by an additional 0.5 up to a high score of 10 which would be intolerable pain.</description>
        <time_frame>Baseline, 12 months</time_frame>
        <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Spinal Cord Stimulator Implant (SCS)</title>
            <description>Spinal Cord Stimulator implant&#xD;
High Frequency Spinal Cord Stimulator: The SCS implant followed standard clinical practice for FDA approved indications: Two percutaneous leads were placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing was performed to ensure electrical integrity. Patients with HF10 SCS received 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming occurred postoperatively and as needed based on patient feedback in standard clinic visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Assessment</title>
          <description>Pain measurement using a Visual Analog Pain Scale by placing an X in the box to indicate the severity of pain from no pain to intolerable pain. The X in the box translates to a score of zero for no pain and increases by an additional 0.5 up to a high score of 10 which would be intolerable pain.</description>
          <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" lower_limit="5.0" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Neuropathy Symptoms and Change (NSC) Score</title>
        <description>Validated questionnaire that evaluates change in neuropathy symptoms, including symptoms of weakness, sensory symptoms, and autonomic symptoms. Answers to questionnaire are yes/no and if yes, then degree of severity is evaluated with a plus one(slight), plus two (moderate) and plus three (severe). Questionnaire screens the presence and severity of diabetic peripheral neuropathy. Change in severity of symptoms are compared over time. Total scores range from 0 - 114, lower scores reflect no neuropathy symptoms, higher scores reflect more neuropathy symptoms.</description>
        <time_frame>baseline, 12 months</time_frame>
        <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Spinal Cord Stimulator Implant (SCS)</title>
            <description>Spinal Cord Stimulator implant&#xD;
High Frequency Spinal Cord Stimulator: The SCS implant followed standard clinical practice for FDA approved indications: Two percutaneous leads were placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing was performed to ensure electrical integrity. Patients with HF10 SCS received 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming occurred postoperatively and as needed based on patient feedback in standard clinic visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Neuropathy Symptoms and Change (NSC) Score</title>
          <description>Validated questionnaire that evaluates change in neuropathy symptoms, including symptoms of weakness, sensory symptoms, and autonomic symptoms. Answers to questionnaire are yes/no and if yes, then degree of severity is evaluated with a plus one(slight), plus two (moderate) and plus three (severe). Questionnaire screens the presence and severity of diabetic peripheral neuropathy. Change in severity of symptoms are compared over time. Total scores range from 0 - 114, lower scores reflect no neuropathy symptoms, higher scores reflect more neuropathy symptoms.</description>
          <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.5" lower_limit="16.0" upper_limit="28.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" lower_limit="6.0" upper_limit="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Oswestry Disability Index</title>
        <description>Questionnaire examines perceived level of disability in 10 everyday activities of daily living including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling. The 6 statements are scored from 0 to 5 scale, zero meaning no disability. The final score ranges from 0-100 with a score of 0-20 equals minimal disability, 21-40 equals moderate disability, 41-60 equals severe disability, 61-80 equals crippled and 81-100 equals bed-bound.</description>
        <time_frame>Baseline, 12 months</time_frame>
        <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Spinal Cord Stimulator Implant (SCS)</title>
            <description>Spinal Cord Stimulator implant&#xD;
High Frequency Spinal Cord Stimulator: The SCS implant followed standard clinical practice for FDA approved indications: Two percutaneous leads were placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing was performed to ensure electrical integrity. Patients with HF10 SCS received 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming occurred postoperatively and as needed based on patient feedback in standard clinic visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Oswestry Disability Index</title>
          <description>Questionnaire examines perceived level of disability in 10 everyday activities of daily living including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling. The 6 statements are scored from 0 to 5 scale, zero meaning no disability. The final score ranges from 0-100 with a score of 0-20 equals minimal disability, 21-40 equals moderate disability, 41-60 equals severe disability, 61-80 equals crippled and 81-100 equals bed-bound.</description>
          <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.0" lower_limit="28.0" upper_limit="56.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.0" lower_limit="12.0" upper_limit="40.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Neuropathy Impairment Score (NIS)</title>
        <description>Subject's scores neuropathic deficits using a scale of 0-4 (zero=normal, 4=paralysis) to measure muscle weakness. The NIS score is a measure of neurologic impairment. The NIS Score has a range of 0 to 244. Lower scores indicate higher function, higher scores indicate lower function.</description>
        <time_frame>Baseline, 12 months</time_frame>
        <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Spinal Cord Stimulator Implant (SCS)</title>
            <description>Spinal Cord Stimulator implant&#xD;
High Frequency Spinal Cord Stimulator: The SCS implant followed standard clinical practice for FDA approved indications: Two percutaneous leads were placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing was performed to ensure electrical integrity. Patients with HF10 SCS received 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming occurred postoperatively and as needed based on patient feedback in standard clinic visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Neuropathy Impairment Score (NIS)</title>
          <description>Subject's scores neuropathic deficits using a scale of 0-4 (zero=normal, 4=paralysis) to measure muscle weakness. The NIS score is a measure of neurologic impairment. The NIS Score has a range of 0 to 244. Lower scores indicate higher function, higher scores indicate lower function.</description>
          <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="12.0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.0" lower_limit="6.0" upper_limit="16.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lower Limb Function Test</title>
        <description>Test for lower limb function in which the subject will need to walk on toes, walk on heels, and arise from kneeled position, each test is marked as not applicable, normal or abnormal. The examination assesses each component for the left and right side separately. If the test is normal, it is given a score of 0, and if it is abnormal, a score of 1. Not applicable scores a zero. Total scores range 0-6. Therefore, the maximum score of 6 indicates abnormality in all 3 components bilaterally and a minimum score of 0 indicates a normal result for all 3 components bilaterally.</description>
        <time_frame>Baseline, 12 months</time_frame>
        <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Spinal Cord Stimulator Implant (SCS)</title>
            <description>Spinal Cord Stimulator implant&#xD;
High Frequency Spinal Cord Stimulator: The SCS implant followed standard clinical practice for FDA approved indications: Two percutaneous leads were placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing was performed to ensure electrical integrity. Patients with HF10 SCS received 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming occurred postoperatively and as needed based on patient feedback in standard clinic visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Lower Limb Function Test</title>
          <description>Test for lower limb function in which the subject will need to walk on toes, walk on heels, and arise from kneeled position, each test is marked as not applicable, normal or abnormal. The examination assesses each component for the left and right side separately. If the test is normal, it is given a score of 0, and if it is abnormal, a score of 1. Not applicable scores a zero. Total scores range 0-6. Therefore, the maximum score of 6 indicates abnormality in all 3 components bilaterally and a minimum score of 0 indicates a normal result for all 3 components bilaterally.</description>
          <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Modified Leads Assessment of Neuropathic Symptoms and Signs</title>
        <description>Questionnaire to identify and analyze pain by answering yes/no which translates to scores from 0-24. A score of 12 or more suggests pain of predominantly neuropathic origin.</description>
        <time_frame>baseline, 12 months</time_frame>
        <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Spinal Cord Stimulator Implant (SCS)</title>
            <description>Spinal Cord Stimulator implant&#xD;
High Frequency Spinal Cord Stimulator: The SCS implant followed standard clinical practice for FDA approved indications: Two percutaneous leads were placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing was performed to ensure electrical integrity. Patients with HF10 SCS received 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming occurred postoperatively and as needed based on patient feedback in standard clinic visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Modified Leads Assessment of Neuropathic Symptoms and Signs</title>
          <description>Questionnaire to identify and analyze pain by answering yes/no which translates to scores from 0-24. A score of 12 or more suggests pain of predominantly neuropathic origin.</description>
          <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.0" lower_limit="16.0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.0" lower_limit="11.0" upper_limit="22.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Positive Pain</title>
        <description>Numeric Rating Scale used to assess pain from a scale of 0 (no pain) to 10 (worst possible pain)</description>
        <time_frame>baseline, 12 months</time_frame>
        <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Spinal Cord Stimulator Implant (SCS)</title>
            <description>Spinal Cord Stimulator implant&#xD;
High Frequency Spinal Cord Stimulator: The SCS implant followed standard clinical practice for FDA approved indications: Two percutaneous leads were placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing was performed to ensure electrical integrity. Patients with HF10 SCS received 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming occurred postoperatively and as needed based on patient feedback in standard clinic visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Positive Pain</title>
          <description>Numeric Rating Scale used to assess pain from a scale of 0 (no pain) to 10 (worst possible pain)</description>
          <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" lower_limit="8.0" upper_limit="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="2.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Health Questionnaire</title>
        <description>Screens for the presence and severity of depression with 9 questions in a scale of 0-3. Zero=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Total score range 0 - 27. A total score of 0-4=minimal depression, 5-9=mild depression, 10-14=moderate depression, 15-19=moderately severe depression, 20-27=severe depression</description>
        <time_frame>Baseline, 12 months</time_frame>
        <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Spinal Cord Stimulator Implant (SCS)</title>
            <description>Spinal Cord Stimulator implant&#xD;
High Frequency Spinal Cord Stimulator: The SCS implant followed standard clinical practice for FDA approved indications: Two percutaneous leads were placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing was performed to ensure electrical integrity. Patients with HF10 SCS received 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming occurred postoperatively and as needed based on patient feedback in standard clinic visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Health Questionnaire</title>
          <description>Screens for the presence and severity of depression with 9 questions in a scale of 0-3. Zero=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Total score range 0 - 27. A total score of 0-4=minimal depression, 5-9=mild depression, 10-14=moderate depression, 15-19=moderately severe depression, 20-27=severe depression</description>
          <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="3.0" upper_limit="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="2.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Height</title>
        <description>Subjects calculated height in centimeters.</description>
        <time_frame>Baseline, 12 months</time_frame>
        <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Spinal Cord Stimulator Implant (SCS)</title>
            <description>Spinal Cord Stimulator implant&#xD;
High Frequency Spinal Cord Stimulator: The SCS implant followed standard clinical practice for FDA approved indications: Two percutaneous leads were placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing was performed to ensure electrical integrity. Patients with HF10 SCS received 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming occurred postoperatively and as needed based on patient feedback in standard clinic visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Height</title>
          <description>Subjects calculated height in centimeters.</description>
          <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
          <units>cm</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="173" lower_limit="160" upper_limit="185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="175" lower_limit="159" upper_limit="186"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weight</title>
        <description>Subjects calculated weight in kilograms</description>
        <time_frame>Baseline, 12 months</time_frame>
        <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Spinal Cord Stimulator Implant (SCS)</title>
            <description>Spinal Cord Stimulator implant&#xD;
High Frequency Spinal Cord Stimulator: The SCS implant followed standard clinical practice for FDA approved indications: Two percutaneous leads were placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing was performed to ensure electrical integrity. Patients with HF10 SCS received 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming occurred postoperatively and as needed based on patient feedback in standard clinic visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Weight</title>
          <description>Subjects calculated weight in kilograms</description>
          <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
          <units>kg</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.0" lower_limit="85.3" upper_limit="107.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.2" lower_limit="92.9" upper_limit="123.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Body Mass Index (BMI)</title>
        <description>Subject's BMI calculated as weight in kilograms divided by height in meters squared. Uses measurements of height and weight obtained during study (with appropriate metric conversions)</description>
        <time_frame>Baseline, 12 months</time_frame>
        <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Spinal Cord Stimulator Implant (SCS)</title>
            <description>Spinal Cord Stimulator implant&#xD;
High Frequency Spinal Cord Stimulator: The SCS implant followed standard clinical practice for FDA approved indications: Two percutaneous leads were placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing was performed to ensure electrical integrity. Patients with HF10 SCS received 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming occurred postoperatively and as needed based on patient feedback in standard clinic visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <description>Subject's BMI calculated as weight in kilograms divided by height in meters squared. Uses measurements of height and weight obtained during study (with appropriate metric conversions)</description>
          <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.3" lower_limit="31.2" upper_limit="36.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.5" lower_limit="31.2" upper_limit="37.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hemoglobin A1c</title>
        <description>Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Reported as percentage of glycated hemoglobin</description>
        <time_frame>Baseline, 12 months</time_frame>
        <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Spinal Cord Stimulator Implant (SCS)</title>
            <description>Spinal Cord Stimulator implant&#xD;
High Frequency Spinal Cord Stimulator: The SCS implant followed standard clinical practice for FDA approved indications: Two percutaneous leads were placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing was performed to ensure electrical integrity. Patients with HF10 SCS received 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming occurred postoperatively and as needed based on patient feedback in standard clinic visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Hemoglobin A1c</title>
          <description>Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Reported as percentage of glycated hemoglobin</description>
          <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
          <units>percentage of glycated hemoglobin</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3" lower_limit="6.1" upper_limit="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.85" lower_limit="6.2" upper_limit="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Forearm Sweat Volume Quantitative Axon Reflex Sweat Test (Q-SWEAT)</title>
        <description>Test that measures the rate and volume of sweat to determine the severity and pattern of autonomic disorders. As measured by µL/cm²</description>
        <time_frame>baseline, 12 months</time_frame>
        <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Spinal Cord Stimulator Implant (SCS)</title>
            <description>Spinal Cord Stimulator implant&#xD;
High Frequency Spinal Cord Stimulator: The SCS implant followed standard clinical practice for FDA approved indications: Two percutaneous leads were placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing was performed to ensure electrical integrity. Patients with HF10 SCS received 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming occurred postoperatively and as needed based on patient feedback in standard clinic visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Forearm Sweat Volume Quantitative Axon Reflex Sweat Test (Q-SWEAT)</title>
          <description>Test that measures the rate and volume of sweat to determine the severity and pattern of autonomic disorders. As measured by µL/cm²</description>
          <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
          <units>µL/cm²</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="0.3" upper_limit="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" lower_limit="0.2" upper_limit="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proximal Leg Laser Doppler Flowmetry (LDF)</title>
        <description>Laser Doppler velocimetry is used in hemodynamics research as a technique to partially quantify blood flow in human tissues such as skin. Within the clinical environment, the technology is often referred to as laser Doppler flowmetry (LDF). As measured in perfusion units (p.u.)</description>
        <time_frame>Baseline, 12 months</time_frame>
        <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Spinal Cord Stimulator Implant (SCS)</title>
            <description>Spinal Cord Stimulator implant&#xD;
High Frequency Spinal Cord Stimulator: The SCS implant followed standard clinical practice for FDA approved indications: Two percutaneous leads were placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing was performed to ensure electrical integrity. Patients with HF10 SCS received 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming occurred postoperatively and as needed based on patient feedback in standard clinic visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Proximal Leg Laser Doppler Flowmetry (LDF)</title>
          <description>Laser Doppler velocimetry is used in hemodynamics research as a technique to partially quantify blood flow in human tissues such as skin. Within the clinical environment, the technology is often referred to as laser Doppler flowmetry (LDF). As measured in perfusion units (p.u.)</description>
          <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
          <units>perfusion units (p.u.)</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2" lower_limit="14.7" upper_limit="28.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.0" lower_limit="18.8" upper_limit="29.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Extensor Digitorum Brevis Muscle Nerve Conduction</title>
        <description>A nerve conduction study (NCS) is a medical diagnostic test commonly used to evaluate the function, especially the ability of electrical conduction, of the motor and sensory nerves of the human body. As measured by amplitude (AMP) milliamp (mA)</description>
        <time_frame>Baseline, 12 months</time_frame>
        <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Spinal Cord Stimulator Implant (SCS)</title>
            <description>Spinal Cord Stimulator implant&#xD;
High Frequency Spinal Cord Stimulator: The SCS implant followed standard clinical practice for FDA approved indications: Two percutaneous leads were placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing was performed to ensure electrical integrity. Patients with HF10 SCS received 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming occurred postoperatively and as needed based on patient feedback in standard clinic visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Extensor Digitorum Brevis Muscle Nerve Conduction</title>
          <description>A nerve conduction study (NCS) is a medical diagnostic test commonly used to evaluate the function, especially the ability of electrical conduction, of the motor and sensory nerves of the human body. As measured by amplitude (AMP) milliamp (mA)</description>
          <population>Data was not collected or analyzed at 12 months for the one subject who did not complete the study.</population>
          <units>AMP (mA)</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" lower_limit="0.6" upper_limit="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.5" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were collected from baseline to end of study, approximately 12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Spinal Cord Stimulator Implant (SCS)</title>
          <description>Spinal Cord Stimulator implant&#xD;
High Frequency Spinal Cord Stimulator: The SCS implant followed standard clinical practice for FDA approved indications: Two percutaneous leads were placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing was performed to ensure electrical integrity. Patients with HF10 SCS received 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming occurred postoperatively and as needed based on patient feedback in standard clinic visits.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Narayan R. Kissoon, M.D.</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-284-4961</phone>
      <email>Kissoon.Narayan@mayo.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03769675
org study id: 17-004317
nct id: NCT03769675
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Will participants with painful lower extremity diabetic peripheral neuropathy (DPN) that are
      treated with high frequency spinal cord stimulation (HF10 SCS) have improvements in lower
      extremity peripheral nerve function?
This research study is being conducted to find out if spinal cord stimulation (SCS) can
      improve nerve function. SCS is FDA approved for the treatment of intractable neuropathic
      (nerve) pain related to diabetic peripheral neuropathy. With SCS a wire is placed in the
      epidural space and the spinal cord is stimulated to interrupt the pain signal coming from the
      legs. The spinal cord stimulator is a device similar to a pacemaker (which helps treat
      abnormal rhythms of the heart). Recent studies have suggested that SCS with high frequencies
      can improve nerve function for subjects with painful peripheral neuropathy therefore, the
      investigators are looking to measure changes in nerve function after SCS for treatment of
      painful diabetic peripheral neuropathy.

      The purpose of this research is to gather information on the effect of high frequency spinal
      cord stimulation (HF10) on nerve function with a spinal cord stimulator.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain Assessment
time frame: Baseline, 12 months
description: Pain measurement using a Visual Analog Pain Scale by placing an X in the box to indicate the severity of pain from no pain to intolerable pain. The X in the box translates to a score of zero for no pain and increases by an additional 0.5 up to a high score of 10 which would be intolerable pain.
measure: Neuropathy Symptoms and Change (NSC) Score
time frame: baseline, 12 months
description: Validated questionnaire that evaluates change in neuropathy symptoms, including symptoms of weakness, sensory symptoms, and autonomic symptoms. Answers to questionnaire are yes/no and if yes, then degree of severity is evaluated with a plus one(slight), plus two (moderate) and plus three (severe). Questionnaire screens the presence and severity of diabetic peripheral neuropathy. Change in severity of symptoms are compared over time. Total scores range from 0 - 114, lower scores reflect no neuropathy symptoms, higher scores reflect more neuropathy symptoms.
measure: Oswestry Disability Index
time frame: Baseline, 12 months
description: Questionnaire examines perceived level of disability in 10 everyday activities of daily living including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling. The 6 statements are scored from 0 to 5 scale, zero meaning no disability. The final score ranges from 0-100 with a score of 0-20 equals minimal disability, 21-40 equals moderate disability, 41-60 equals severe disability, 61-80 equals crippled and 81-100 equals bed-bound.
measure: Neuropathy Impairment Score (NIS)
time frame: Baseline, 12 months
description: Subject's scores neuropathic deficits using a scale of 0-4 (zero=normal, 4=paralysis) to measure muscle weakness. The NIS score is a measure of neurologic impairment. The NIS Score has a range of 0 to 244. Lower scores indicate higher function, higher scores indicate lower function.
measure: Lower Limb Function Test
time frame: Baseline, 12 months
description: Test for lower limb function in which the subject will need to walk on toes, walk on heels, and arise from kneeled position, each test is marked as not applicable, normal or abnormal. The examination assesses each component for the left and right side separately. If the test is normal, it is given a score of 0, and if it is abnormal, a score of 1. Not applicable scores a zero. Total scores range 0-6. Therefore, the maximum score of 6 indicates abnormality in all 3 components bilaterally and a minimum score of 0 indicates a normal result for all 3 components bilaterally.
measure: Modified Leads Assessment of Neuropathic Symptoms and Signs
time frame: baseline, 12 months
description: Questionnaire to identify and analyze pain by answering yes/no which translates to scores from 0-24. A score of 12 or more suggests pain of predominantly neuropathic origin.
measure: Positive Pain
time frame: baseline, 12 months
description: Numeric Rating Scale used to assess pain from a scale of 0 (no pain) to 10 (worst possible pain)
measure: Patient Health Questionnaire
time frame: Baseline, 12 months
description: Screens for the presence and severity of depression with 9 questions in a scale of 0-3. Zero=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Total score range 0 - 27. A total score of 0-4=minimal depression, 5-9=mild depression, 10-14=moderate depression, 15-19=moderately severe depression, 20-27=severe depression
measure: Height
time frame: Baseline, 12 months
description: Subjects calculated height in centimeters.
measure: Weight
time frame: Baseline, 12 months
description: Subjects calculated weight in kilograms
measure: Body Mass Index (BMI)
time frame: Baseline, 12 months
description: Subject's BMI calculated as weight in kilograms divided by height in meters squared. Uses measurements of height and weight obtained during study (with appropriate metric conversions)
measure: Hemoglobin A1c
time frame: Baseline, 12 months
description: Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Reported as percentage of glycated hemoglobin
measure: Forearm Sweat Volume Quantitative Axon Reflex Sweat Test (Q-SWEAT)
time frame: baseline, 12 months
description: Test that measures the rate and volume of sweat to determine the severity and pattern of autonomic disorders. As measured by µL/cm²
measure: Proximal Leg Laser Doppler Flowmetry (LDF)
time frame: Baseline, 12 months
description: Laser Doppler velocimetry is used in hemodynamics research as a technique to partially quantify blood flow in human tissues such as skin. Within the clinical environment, the technology is often referred to as laser Doppler flowmetry (LDF). As measured in perfusion units (p.u.)
measure: Extensor Digitorum Brevis Muscle Nerve Conduction
time frame: Baseline, 12 months
description: A nerve conduction study (NCS) is a medical diagnostic test commonly used to evaluate the function, especially the ability of electrical conduction, of the motor and sensory nerves of the human body. As measured by amplitude (AMP) milliamp (mA)
arm group label: Spinal Cord Stimulator Implant
arm group type: Experimental
description: Spinal Cord Stimulator implant
intervention type: Device
intervention name: High Frequency Spinal Cord Stimulator
description: The SCS implant will follow standard clinical practice for these FDA approved indications. Two percutaneous leads will be placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator (trial phase) or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing will be performed to ensure electrical integrity. Patients with HF10 SCS will receive 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming will occur postoperatively and as needed based on patient feedback in standard clinic visits. .
arm group label: Spinal Cord Stimulator Implant
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Narayan R Kissoon
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Narayan R. Kissoon
investigator title: Principal Investigator
mesh term: Peripheral Nervous System Diseases
mesh term: Diabetic Neuropathies
mesh term: Pain
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 