<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/NCT02227758</url>
  </required_header>
  <id_info>
    <org_study_id>NM-11-059-EU-ON</org_study_id>
    <nct_id>NCT02227758</nct_id>
  </id_info>
  <brief_title>Peripheral Nerve Stimulation Registry for Intractable Migraine Headache</brief_title>
  <acronym>Relief</acronym>
  <official_title>Peripheral Nerve Stimulation Registry for Intractable Migraine Headache</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the long-term safety and performance of&#xD;
      neurostimulation for the treatment of intractable chronic migraine as well as to detect&#xD;
      infrequent complications or problems only apparent in &quot;real-world&quot; practice&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events (First 12 Weeks)</measure>
    <time_frame>3 months</time_frame>
    <description>Events were classified as hardware related when a malfunction or migration of any device component including leads, extensions, IPG's, occurred. Events will classified as biological in cases where there was a biological reaction (hematoma, pain, etc.) to either the device or the surgical procedure to implant the device. Events were classified as stimulation related if the event was known to be caused by stimulation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Headache Pain Relief</measure>
    <time_frame>3 months</time_frame>
    <description>Patient reported headache pain relief in percentage for the previous month; patients were asked about their pain relief in percentage in the previous month; patient were asked &quot;in the last month&quot;, how much headache relief has the implant provided (0% represents no relief, 100% represents complete relief)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Headache Days</measure>
    <time_frame>3 months</time_frame>
    <description>Percentage change in number of Headache days from Baseline to 3 Months. Headache days are the amount of days the subject had an headache in the previous 3 months as captured by the MIDAS questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Migraine Disability</measure>
    <time_frame>3 months</time_frame>
    <description>Percentage change in Midas score from Baseline to 3 Months. The Midas questionnaire consists out of 5 questions to be answered by the patient. Three questions address the number of missed days due to headache in school or paid work, household work and family, social or leasure activities. The two remaining questions document the number of additional days with significant limitations to activity (defined as at least 50% reduced productivity) in the domains of employment and household work. The total score is the sum of days completed for questions 1-5. Midas score ranges from 0 to 21+ with higher values indicating greater disability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>3 months</time_frame>
    <description>Patients very satisfied or satisfied with the headache relief since the implant. Patients were asked about their satisfaction (very satisfied, satisfied, neither satisfied or dissatisfied, unsatisfied, very unsatisfied)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physician Satisfaction</measure>
    <time_frame>3 months</time_frame>
    <description>Patients for who the physician is very satisfied or satisfied with the patient headache relief since the implant. Physicians were asked about their satisfaction (very satisfied, satisfied, neither satisfied or dissatisfied, unsatisfied, very unsatisfied)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>3 months</time_frame>
    <description>Patients who reported the change in overall quality of life since the implant with greatly improved or improved. Patients were asked about their change in overall quality of life (Greatly improved, improved, neither improved or deteriorated, deteriorated, greatly deteriorated)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>3 months</time_frame>
    <description>Patients for who the physician reported the change in overall quality of life of the patient since the implant with greatly improved or improved. Physicians were asked about the change in overall quality of life of the patient(Greatly improved, improved, neither improved or deteriorated, deteriorated, greatly deteriorated)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">112</enrollment>
  <condition>Intractable Chronic Migraine</condition>
  <arm_group>
    <arm_group_label>implanted chronic migraine patients</arm_group_label>
    <description>Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with intractable chronic migraine and implanted with a St.Jude Medical&#xD;
        conformité européenne approved implantable neurostimulation system&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  Patient is 18 years of age or older.&#xD;
&#xD;
          -  Patient has signed and received a copy of the Informed Consent form;&#xD;
&#xD;
          -  Patient has been implanted with a St. Jude Medical CE approved implantable&#xD;
             neurostimulation system for the treatment of intractable chronic migraine:&#xD;
&#xD;
               -  Patient diagnosed with chronic migraine (15 or more days per month with headache&#xD;
                  lasting at least 4 hours per day)&#xD;
&#xD;
               -  Patient has failed three or more preventative drugs for treatment of their&#xD;
                  migraine&#xD;
&#xD;
               -  Patient has at least moderate disability determined using a validated migraine&#xD;
                  disability instrument [e.g., MIDAS &gt;11 or HIT-6 &gt;56]&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Heilig Hartziekenhuis</name>
      <address>
        <city>Roeselare</city>
        <state>West-Vlaanderen</state>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Régional de la CITADELLE</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Delmenhorst GmbH</name>
      <address>
        <city>Delmenhorst</city>
        <state>Großherzogtum Oldenburg</state>
        <zip>27753</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Düsseldorf</name>
      <address>
        <city>Düsseldorf</city>
        <state>Nordrhein-Westfalen</state>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis fur Neurologie, Spezielle Schmerztherapie, Psychotherapie</name>
      <address>
        <city>Essen</city>
        <state>Nordrhein-Westfalen</state>
        <zip>45133</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Essen</name>
      <address>
        <city>Essen</city>
        <state>Nordrhein-Westfalen</state>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Migräne and Kopfschmerzklinik Königstein</name>
      <address>
        <city>Königstein</city>
        <state>Saksen</state>
        <zip>61462</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schmerzklinik und Praxis an der Schmerzklinik Kiel</name>
      <address>
        <city>Kiel</city>
        <state>Schleswig-Holstein</state>
        <zip>24129</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurologische Klinik und Poliklinik Charité Campus Mitte</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Luxembourg</name>
      <address>
        <city>Luxembourg</city>
        <zip>1210</zip>
        <country>Luxembourg</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio</name>
      <address>
        <city>Sevilla</city>
        <state>Andalucia</state>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Puerta de Hierro</name>
      <address>
        <city>Madrid</city>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Hospital</name>
      <address>
        <city>Stockholm</city>
        <state>Stockholms Län</state>
        <zip>17176</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Radcliffe hospital</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX39DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal London Hospital</name>
      <address>
        <city>London</city>
        <state>Royal London Hospital</state>
        <zip>E1 1BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seacroft Hospital</name>
      <address>
        <city>Leeds</city>
        <state>Yorkshire</state>
        <zip>LS146UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital</name>
      <address>
        <city>London</city>
        <zip>sE5 9NT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Germany</country>
    <country>Luxembourg</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Netherlands</country>
  </removed_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>April 16, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <results_first_submitted>March 13, 2017</results_first_submitted>
  <results_first_submitted_qc>June 27, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 31, 2018</results_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Implanted Chronic Migraine Patients</title>
          <description>Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="112"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Implanted Chronic Migraine Patients</title>
          <description>Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="112"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.9" lower_limit="20" upper_limit="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Sweden</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Luxembourg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Adverse Events (First 12 Weeks)</title>
        <description>Events were classified as hardware related when a malfunction or migration of any device component including leads, extensions, IPG's, occurred. Events will classified as biological in cases where there was a biological reaction (hematoma, pain, etc.) to either the device or the surgical procedure to implant the device. Events were classified as stimulation related if the event was known to be caused by stimulation.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Implanted Chronic Migraine Patients</title>
            <description>Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events (First 12 Weeks)</title>
          <description>Events were classified as hardware related when a malfunction or migration of any device component including leads, extensions, IPG's, occurred. Events will classified as biological in cases where there was a biological reaction (hematoma, pain, etc.) to either the device or the surgical procedure to implant the device. Events were classified as stimulation related if the event was known to be caused by stimulation.</description>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hardware-related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Biological AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stimulation related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Headache Pain Relief</title>
        <description>Patient reported headache pain relief in percentage for the previous month; patients were asked about their pain relief in percentage in the previous month; patient were asked &quot;in the last month&quot;, how much headache relief has the implant provided (0% represents no relief, 100% represents complete relief)</description>
        <time_frame>3 months</time_frame>
        <population>82 patients had available data for pain relief in the previous month at the 3 month follow-up visit</population>
        <group_list>
          <group group_id="O1">
            <title>Implanted Chronic Migraine Patients</title>
            <description>Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system</description>
          </group>
        </group_list>
        <measure>
          <title>Headache Pain Relief</title>
          <description>Patient reported headache pain relief in percentage for the previous month; patients were asked about their pain relief in percentage in the previous month; patient were asked &quot;in the last month&quot;, how much headache relief has the implant provided (0% represents no relief, 100% represents complete relief)</description>
          <population>82 patients had available data for pain relief in the previous month at the 3 month follow-up visit</population>
          <units>percentage pain relief</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.1" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Headache Days</title>
        <description>Percentage change in number of Headache days from Baseline to 3 Months. Headache days are the amount of days the subject had an headache in the previous 3 months as captured by the MIDAS questionnaire.</description>
        <time_frame>3 months</time_frame>
        <population>69 patients had available data for headache days in the previous 3 months at the 3 month follow-up visit</population>
        <group_list>
          <group group_id="O1">
            <title>Implanted Chronic Migraine Patients</title>
            <description>Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system</description>
          </group>
        </group_list>
        <measure>
          <title>Headache Days</title>
          <description>Percentage change in number of Headache days from Baseline to 3 Months. Headache days are the amount of days the subject had an headache in the previous 3 months as captured by the MIDAS questionnaire.</description>
          <population>69 patients had available data for headache days in the previous 3 months at the 3 month follow-up visit</population>
          <units>percent change in headache days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Migraine Disability</title>
        <description>Percentage change in Midas score from Baseline to 3 Months. The Midas questionnaire consists out of 5 questions to be answered by the patient. Three questions address the number of missed days due to headache in school or paid work, household work and family, social or leasure activities. The two remaining questions document the number of additional days with significant limitations to activity (defined as at least 50% reduced productivity) in the domains of employment and household work. The total score is the sum of days completed for questions 1-5. Midas score ranges from 0 to 21+ with higher values indicating greater disability.</description>
        <time_frame>3 months</time_frame>
        <population>63 patients had available data for all 5 questions of the Midas questionnaire computing the total score at the 3 month follow-up visit. Excluding the outliers, 59 patients had available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Midas Score Including 4 Outliers</title>
            <description>Including outliers with a reported increase of 128%, 148%, 225% and 434% at 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Midas Score Excluding 4 Outliers</title>
            <description>Excluding outliers with a reported increase of 128%,148%, 225%, 434%</description>
          </group>
        </group_list>
        <measure>
          <title>Migraine Disability</title>
          <description>Percentage change in Midas score from Baseline to 3 Months. The Midas questionnaire consists out of 5 questions to be answered by the patient. Three questions address the number of missed days due to headache in school or paid work, household work and family, social or leasure activities. The two remaining questions document the number of additional days with significant limitations to activity (defined as at least 50% reduced productivity) in the domains of employment and household work. The total score is the sum of days completed for questions 1-5. Midas score ranges from 0 to 21+ with higher values indicating greater disability.</description>
          <population>63 patients had available data for all 5 questions of the Midas questionnaire computing the total score at the 3 month follow-up visit. Excluding the outliers, 59 patients had available data.</population>
          <units>percentage of change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74" spread="6.2"/>
                    <measurement group_id="O2" value="-37" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Satisfaction</title>
        <description>Patients very satisfied or satisfied with the headache relief since the implant. Patients were asked about their satisfaction (very satisfied, satisfied, neither satisfied or dissatisfied, unsatisfied, very unsatisfied)</description>
        <time_frame>3 months</time_frame>
        <population>84 subjects had available data for patient satisfaction at the 3 month follow-up visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Implanted Chronic Migraine Patients</title>
            <description>Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Patients very satisfied or satisfied with the headache relief since the implant. Patients were asked about their satisfaction (very satisfied, satisfied, neither satisfied or dissatisfied, unsatisfied, very unsatisfied)</description>
          <population>84 subjects had available data for patient satisfaction at the 3 month follow-up visit.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Physician Satisfaction</title>
        <description>Patients for who the physician is very satisfied or satisfied with the patient headache relief since the implant. Physicians were asked about their satisfaction (very satisfied, satisfied, neither satisfied or dissatisfied, unsatisfied, very unsatisfied)</description>
        <time_frame>3 months</time_frame>
        <population>84 subjects had available data for physician satisfaction at the 3 month follow-up visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Implanted Chronic Migraine Patients</title>
            <description>Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system</description>
          </group>
        </group_list>
        <measure>
          <title>Physician Satisfaction</title>
          <description>Patients for who the physician is very satisfied or satisfied with the patient headache relief since the implant. Physicians were asked about their satisfaction (very satisfied, satisfied, neither satisfied or dissatisfied, unsatisfied, very unsatisfied)</description>
          <population>84 subjects had available data for physician satisfaction at the 3 month follow-up visit.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Quality of Life</title>
        <description>Patients who reported the change in overall quality of life since the implant with greatly improved or improved. Patients were asked about their change in overall quality of life (Greatly improved, improved, neither improved or deteriorated, deteriorated, greatly deteriorated)</description>
        <time_frame>3 months</time_frame>
        <population>83 subjects had available data for Quality of life at the 3 month follow-up visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Implanted Chronic Migraine Patients</title>
            <description>Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life</title>
          <description>Patients who reported the change in overall quality of life since the implant with greatly improved or improved. Patients were asked about their change in overall quality of life (Greatly improved, improved, neither improved or deteriorated, deteriorated, greatly deteriorated)</description>
          <population>83 subjects had available data for Quality of life at the 3 month follow-up visit.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Quality of Life</title>
        <description>Patients for who the physician reported the change in overall quality of life of the patient since the implant with greatly improved or improved. Physicians were asked about the change in overall quality of life of the patient(Greatly improved, improved, neither improved or deteriorated, deteriorated, greatly deteriorated)</description>
        <time_frame>3 months</time_frame>
        <population>84 subjects had available data for physician reported overall quality of life</population>
        <group_list>
          <group group_id="O1">
            <title>Implanted Chronic Migraine Patients</title>
            <description>Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life</title>
          <description>Patients for who the physician reported the change in overall quality of life of the patient since the implant with greatly improved or improved. Physicians were asked about the change in overall quality of life of the patient(Greatly improved, improved, neither improved or deteriorated, deteriorated, greatly deteriorated)</description>
          <population>84 subjects had available data for physician reported overall quality of life</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <desc>Serious Device Related Adverse Events are described. The AE's reported on clinicaltrials.gov have a threshold of 5%</desc>
      <group_list>
        <group group_id="E1">
          <title>Implanted Chronic Migraine Patients</title>
          <description>Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system who experienced a Serious Device related adverse event</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection: IPG and lead site</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Infection: lead site only</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Breakage/facture of the extension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Device Malfunction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Lead breakage/fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>IPG migration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Lead migration</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>persistant pain and/or numbness: IPG site only</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>persistant pain and/or numbness: lead site only</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>persistent pain at connector site</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>skin erosion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Wound site complications</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="7" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Persistent pain and/or numbness</sub_title>
                <description>For 7 patients, there were reports of persistent pain and/or numbness at the lead and/or IPG site</description>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Study Director</name_or_title>
      <organization>St Jude Medical/Abbott</organization>
      <email>rdiaz@sjm.com</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/NCT02227758
org study id: NM-11-059-EU-ON
nct id: NCT02227758
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the long-term safety and performance of
      neurostimulation for the treatment of intractable chronic migraine as well as to detect
      infrequent complications or problems only apparent in "real-world" practice
observational model: Case-Only
time perspective: Prospective
measure: Adverse Events (First 12 Weeks)
time frame: 3 months
description: Events were classified as hardware related when a malfunction or migration of any device component including leads, extensions, IPG's, occurred. Events will classified as biological in cases where there was a biological reaction (hematoma, pain, etc.) to either the device or the surgical procedure to implant the device. Events were classified as stimulation related if the event was known to be caused by stimulation.
measure: Headache Pain Relief
time frame: 3 months
description: Patient reported headache pain relief in percentage for the previous month; patients were asked about their pain relief in percentage in the previous month; patient were asked "in the last month", how much headache relief has the implant provided (0% represents no relief, 100% represents complete relief)
measure: Headache Days
time frame: 3 months
description: Percentage change in number of Headache days from Baseline to 3 Months. Headache days are the amount of days the subject had an headache in the previous 3 months as captured by the MIDAS questionnaire.
measure: Migraine Disability
time frame: 3 months
description: Percentage change in Midas score from Baseline to 3 Months. The Midas questionnaire consists out of 5 questions to be answered by the patient. Three questions address the number of missed days due to headache in school or paid work, household work and family, social or leasure activities. The two remaining questions document the number of additional days with significant limitations to activity (defined as at least 50% reduced productivity) in the domains of employment and household work. The total score is the sum of days completed for questions 1-5. Midas score ranges from 0 to 21+ with higher values indicating greater disability.
measure: Patient Satisfaction
time frame: 3 months
description: Patients very satisfied or satisfied with the headache relief since the implant. Patients were asked about their satisfaction (very satisfied, satisfied, neither satisfied or dissatisfied, unsatisfied, very unsatisfied)
measure: Physician Satisfaction
time frame: 3 months
description: Patients for who the physician is very satisfied or satisfied with the patient headache relief since the implant. Physicians were asked about their satisfaction (very satisfied, satisfied, neither satisfied or dissatisfied, unsatisfied, very unsatisfied)
measure: Quality of Life
time frame: 3 months
description: Patients who reported the change in overall quality of life since the implant with greatly improved or improved. Patients were asked about their change in overall quality of life (Greatly improved, improved, neither improved or deteriorated, deteriorated, greatly deteriorated)
measure: Quality of Life
time frame: 3 months
description: Patients for who the physician reported the change in overall quality of life of the patient since the implant with greatly improved or improved. Physicians were asked about the change in overall quality of life of the patient(Greatly improved, improved, neither improved or deteriorated, deteriorated, greatly deteriorated)
arm group label: implanted chronic migraine patients
description: Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
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country: Belgium
country: Germany
country: Luxembourg
country: Spain
country: Sweden
country: United Kingdom
country: Netherlands
responsible party type: Sponsor
mesh term: Migraine Disorders
mesh term: Headache
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 