<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/NCT02991430</url>
  </required_header>
  <id_info>
    <org_study_id>SNS-MIG-02</org_study_id>
    <nct_id>NCT02991430</nct_id>
  </id_info>
  <brief_title>A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache</brief_title>
  <official_title>A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Scion NeuroStim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Scion NeuroStim</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_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess the efficacy of a neuromodulation device for the treatment of episodic&#xD;
      migraine headache.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a multi-center, triple-blinded, placebo-controlled, randomized clinical trial&#xD;
      for adjunctive prophylactic treatment of episodic migraine headache (with or without aura)&#xD;
      using neuromodulation device developed by Scion NeuroStim, LLC (SNS). The investigational use&#xD;
      of the device for episodic migraine headache has been reviewed by the FDA and is classified&#xD;
      as NSR (non-significant risk).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Inability to supply and maintain treatment device. No safety concerns occurred.&#xD;
  </why_stopped>
  <start_date type="Actual">June 30, 2017</start_date>
  <completion_date type="Actual">May 11, 2018</completion_date>
  <primary_completion_date type="Actual">May 11, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Migraine Headache Days (MHD)</measure>
    <time_frame>1 month of baseline recordation followed by 84 days of device use</time_frame>
    <description>comparison of MHD recorded in baseline month versus 3rd month of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Normalized Reduction in Migraine Headache Days</measure>
    <time_frame>1 month of baseline recordation followed by 84 days of device use</time_frame>
    <description>comparison of MHD recorded in baseline month versus 3rd month of treatment: percentages, active versus placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Medication Usage</measure>
    <time_frame>1 month of baseline recordation followed by 84 days of device use</time_frame>
    <description>reduction in acute, prescribed medications in month 3 of treatment versus baseline month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Headache Pain</measure>
    <time_frame>1 month of baseline recordation followed by 84 days of device use</time_frame>
    <description>reduction in subject perceived headache pain scores in month 3 of treatment versus baseline month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>1 month of baseline recordation followed by 84 days of device use</time_frame>
    <description>comparison of HIT-6 (headache impact test) scores between baseline month and treatment month 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depression</measure>
    <time_frame>1 month of baseline recordation followed by 84 days of device use</time_frame>
    <description>comparison of BDI-II (Beck depression index) scores between baseline month and treatment month 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Anxiety</measure>
    <time_frame>1 month of baseline recordation followed by 84 days of device use</time_frame>
    <description>comparison of BAI (Beck anxiety index) scores between baseline month and treatment month 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sleep Quality</measure>
    <time_frame>1 month of baseline recordation followed by 84 days of device use</time_frame>
    <description>comparison of Pittsburgh Sleep assessment scores between baseline month and treatment month 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Additional Treatment Time</measure>
    <time_frame>1 month of baseline recordation followed by 168 days of device use</time_frame>
    <description>comparison of MHD recorded in baseline month versus 6th month of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sustained Reduction in Migraine Headache Days</measure>
    <time_frame>1 month of baseline recordation followed by 252 days of device use</time_frame>
    <description>comparison of MHD recorded in baseline month versus post-treatment months 7, 8 and 9</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Intervention</condition>
  <arm_group>
    <arm_group_label>active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>active neuromodulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo neuromodulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>active neuromodulation for episodic migraine headache</intervention_name>
    <description>Non-invasive brainstem neuromodulator. Active and placebo devices appear identical</description>
    <arm_group_label>active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>placebo neuromodulation for episodic migraine headache</intervention_name>
    <description>Sham non-invasive brainstem neuromodulator. Active and placebo devices appear identical</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed with episodic migraine at least 6 months before study&#xD;
&#xD;
          -  at least 3 consecutive months of stable migraine headaches before study&#xD;
&#xD;
          -  at least 4-14 headache days per month, of which 4-14 may be migraines&#xD;
&#xD;
          -  must not have failed on more than 2 classes of migraine preventatives&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous use of the experimental device&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  using more than 1 concurrent migraine preventive&#xD;
&#xD;
          -  history of cardiovascular disease&#xD;
&#xD;
          -  work night shifts&#xD;
&#xD;
          -  diagnosed with vestibular migraine&#xD;
&#xD;
          -  menstrual migraines exclusively&#xD;
&#xD;
          -  diagnosed with post-traumatic migraine&#xD;
&#xD;
          -  have a history of unstable mood or anxiety disorder&#xD;
&#xD;
          -  use a hearing aid&#xD;
&#xD;
          -  have a cochlear implant&#xD;
&#xD;
          -  have chronic tinnitus&#xD;
&#xD;
          -  have temporomandibular joint disease&#xD;
&#xD;
          -  diagnosed with traumatic brain injury&#xD;
&#xD;
          -  diagnosed with neurological disease other than headaches&#xD;
&#xD;
          -  diagnosed vestibular and/or balance dysfunction&#xD;
&#xD;
          -  history of abusing alcohol or other drugs&#xD;
&#xD;
          -  are experiencing medication overuse headaches&#xD;
&#xD;
          -  have had eye surgery in the previous 3 months&#xD;
&#xD;
          -  have had ear surgery in the previous 6 months&#xD;
&#xD;
          -  have active ear infections or a perforated tympanic membrane&#xD;
&#xD;
          -  have participated in another clinical trial in the last 30 days&#xD;
&#xD;
          -  are currently participating in another clinical trial&#xD;
&#xD;
          -  using Botulinum toxin-based treatments for migraines or cosmetic reasons&#xD;
&#xD;
          -  taking anti-emetics more than 2 times per week (consistently)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurology Research Institute</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diamond Headache Clinic</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Headache Pain &amp; Neurological Inst.</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Metrix Research</name>
      <address>
        <city>Saint Peters</city>
        <state>Missouri</state>
        <zip>63303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jefferson Headache Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College London</name>
      <address>
        <city>London</city>
        <state>Denmark Hill</state>
        <zip>SE5 9PJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kent</name>
      <address>
        <city>Canterbury</city>
        <state>Kent</state>
        <zip>CT2 7NP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <results_first_submitted>May 9, 2019</results_first_submitted>
  <results_first_submitted_qc>June 15, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 19, 2019</results_first_posted>
  <last_update_submitted>June 15, 2019</last_update_submitted>
  <last_update_submitted_qc>June 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>migraine headache, episodic</keyword>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>August 9, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT02991430/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>BID Placebo</title>
          <description>Participants self-administered twice-daily inactive/sham treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
        </group>
        <group group_id="P2">
          <title>BID Active</title>
          <description>Participants self-administered twice-daily active treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
        </group>
        <group group_id="P3">
          <title>QD Active</title>
          <description>Participants self-administered once-daily active treatments for 12 weeks (treatment period 1) followed by once-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study Termination</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Post-treatment Observation Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study Termination</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>BID Placebo</title>
          <description>Participants self-administered twice-daily inactive/sham treatments for 12 weeks followed by twice-daily active treatments for 12 weeks followed by a post-treatment observation period lasting 12 months.</description>
        </group>
        <group group_id="B2">
          <title>BID Active</title>
          <description>Participants self-administered twice-daily treatments for 12 weeks followed by twice-daily active treatments for an additional 12 weeks followed by a post-treatment observation period lasting 12 months.</description>
        </group>
        <group group_id="B3">
          <title>QD Active</title>
          <description>Participants self-administered once-daily treatments for 12 weeks followed by once-daily active treatments for an additional 12 weeks followed by a post-treatment observation period lasting 12 months.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="16"/>
            <count group_id="B4" value="45"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="16"/>
                    <count group_id="B4" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.3" spread="12.2"/>
                    <measurement group_id="B2" value="43.9" spread="11.3"/>
                    <measurement group_id="B3" value="43.5" spread="10.8"/>
                    <measurement group_id="B4" value="43.87" spread="11.28"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="16"/>
                    <count group_id="B4" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="8"/>
                  </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 group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Monthly migraine days</title>
          <description>Monthly migraine days within the 28 day baseline according to an electronic daily diary.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="16"/>
                    <count group_id="B4" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.9" spread="1.7"/>
                    <measurement group_id="B2" value="7.7" spread="1.9"/>
                    <measurement group_id="B3" value="7.5" spread="2.4"/>
                    <measurement group_id="B4" value="7.8" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Migraine Headache Days (MHD)</title>
        <description>comparison of MHD recorded in baseline month versus 3rd month of treatment</description>
        <time_frame>1 month of baseline recordation followed by 84 days of device use</time_frame>
        <population>The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.</population>
        <group_list>
          <group group_id="O1">
            <title>BID Placebo</title>
            <description>Participants self-administered twice-daily inactive/sham treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
          <group group_id="O2">
            <title>BID Active</title>
            <description>Participants self-administered twice-daily active treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
          <group group_id="O3">
            <title>QD Active</title>
            <description>Participants self-administered once-daily active treatments for 12 weeks (treatment period 1) followed by once-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Migraine Headache Days (MHD)</title>
          <description>comparison of MHD recorded in baseline month versus 3rd month of treatment</description>
          <population>The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Normalized Reduction in Migraine Headache Days</title>
        <description>comparison of MHD recorded in baseline month versus 3rd month of treatment: percentages, active versus placebo</description>
        <time_frame>1 month of baseline recordation followed by 84 days of device use</time_frame>
        <population>The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.</population>
        <group_list>
          <group group_id="O1">
            <title>BID Placebo</title>
            <description>Participants self-administered twice-daily inactive/sham treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
          <group group_id="O2">
            <title>BID Active</title>
            <description>Participants self-administered twice-daily active treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
          <group group_id="O3">
            <title>QD Active</title>
            <description>Participants self-administered once-daily active treatments for 12 weeks (treatment period 1) followed by once-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
        </group_list>
        <measure>
          <title>Normalized Reduction in Migraine Headache Days</title>
          <description>comparison of MHD recorded in baseline month versus 3rd month of treatment: percentages, active versus placebo</description>
          <population>The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Medication Usage</title>
        <description>reduction in acute, prescribed medications in month 3 of treatment versus baseline month</description>
        <time_frame>1 month of baseline recordation followed by 84 days of device use</time_frame>
        <population>The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.</population>
        <group_list>
          <group group_id="O1">
            <title>BID Placebo</title>
            <description>Participants self-administered twice-daily inactive/sham treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
          <group group_id="O2">
            <title>BID Active</title>
            <description>Participants self-administered twice-daily active treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
          <group group_id="O3">
            <title>QD Active</title>
            <description>Participants self-administered once-daily active treatments for 12 weeks (treatment period 1) followed by once-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Medication Usage</title>
          <description>reduction in acute, prescribed medications in month 3 of treatment versus baseline month</description>
          <population>The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Headache Pain</title>
        <description>reduction in subject perceived headache pain scores in month 3 of treatment versus baseline month</description>
        <time_frame>1 month of baseline recordation followed by 84 days of device use</time_frame>
        <population>The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.</population>
        <group_list>
          <group group_id="O1">
            <title>BID Placebo</title>
            <description>Participants self-administered twice-daily inactive/sham treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
          <group group_id="O2">
            <title>BID Active</title>
            <description>Participants self-administered twice-daily active treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
          <group group_id="O3">
            <title>QD Active</title>
            <description>Participants self-administered once-daily active treatments for 12 weeks (treatment period 1) followed by once-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Headache Pain</title>
          <description>reduction in subject perceived headache pain scores in month 3 of treatment versus baseline month</description>
          <population>The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Quality of Life</title>
        <description>comparison of HIT-6 (headache impact test) scores between baseline month and treatment month 3</description>
        <time_frame>1 month of baseline recordation followed by 84 days of device use</time_frame>
        <population>The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.</population>
        <group_list>
          <group group_id="O1">
            <title>BID Placebo</title>
            <description>Participants self-administered twice-daily inactive/sham treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
          <group group_id="O2">
            <title>BID Active</title>
            <description>Participants self-administered twice-daily active treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
          <group group_id="O3">
            <title>QD Active</title>
            <description>Participants self-administered once-daily active treatments for 12 weeks (treatment period 1) followed by once-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life</title>
          <description>comparison of HIT-6 (headache impact test) scores between baseline month and treatment month 3</description>
          <population>The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Depression</title>
        <description>comparison of BDI-II (Beck depression index) scores between baseline month and treatment month 3</description>
        <time_frame>1 month of baseline recordation followed by 84 days of device use</time_frame>
        <population>The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.</population>
        <group_list>
          <group group_id="O1">
            <title>BID Placebo</title>
            <description>Participants self-administered twice-daily inactive/sham treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
          <group group_id="O2">
            <title>BID Active</title>
            <description>Participants self-administered twice-daily active treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
          <group group_id="O3">
            <title>QD Active</title>
            <description>Participants self-administered once-daily active treatments for 12 weeks (treatment period 1) followed by once-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Depression</title>
          <description>comparison of BDI-II (Beck depression index) scores between baseline month and treatment month 3</description>
          <population>The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Anxiety</title>
        <description>comparison of BAI (Beck anxiety index) scores between baseline month and treatment month 3</description>
        <time_frame>1 month of baseline recordation followed by 84 days of device use</time_frame>
        <population>The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.</population>
        <group_list>
          <group group_id="O1">
            <title>BID Placebo</title>
            <description>Participants self-administered twice-daily inactive/sham treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
          <group group_id="O2">
            <title>BID Active</title>
            <description>Participants self-administered twice-daily active treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
          <group group_id="O3">
            <title>QD Active</title>
            <description>Participants self-administered once-daily active treatments for 12 weeks (treatment period 1) followed by once-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Anxiety</title>
          <description>comparison of BAI (Beck anxiety index) scores between baseline month and treatment month 3</description>
          <population>The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Sleep Quality</title>
        <description>comparison of Pittsburgh Sleep assessment scores between baseline month and treatment month 3</description>
        <time_frame>1 month of baseline recordation followed by 84 days of device use</time_frame>
        <population>The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.</population>
        <group_list>
          <group group_id="O1">
            <title>BID Placebo</title>
            <description>Participants self-administered twice-daily inactive/sham treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
          <group group_id="O2">
            <title>BID Active</title>
            <description>Participants self-administered twice-daily active treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
          <group group_id="O3">
            <title>QD Active</title>
            <description>Participants self-administered once-daily active treatments for 12 weeks (treatment period 1) followed by once-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sleep Quality</title>
          <description>comparison of Pittsburgh Sleep assessment scores between baseline month and treatment month 3</description>
          <population>The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Additional Treatment Time</title>
        <description>comparison of MHD recorded in baseline month versus 6th month of treatment</description>
        <time_frame>1 month of baseline recordation followed by 168 days of device use</time_frame>
        <population>The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.</population>
        <group_list>
          <group group_id="O1">
            <title>BID Placebo</title>
            <description>Participants self-administered twice-daily inactive/sham treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
          <group group_id="O2">
            <title>BID Active</title>
            <description>Participants self-administered twice-daily active treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
          <group group_id="O3">
            <title>QD Active</title>
            <description>Participants self-administered once-daily active treatments for 12 weeks (treatment period 1) followed by once-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
        </group_list>
        <measure>
          <title>Additional Treatment Time</title>
          <description>comparison of MHD recorded in baseline month versus 6th month of treatment</description>
          <population>The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sustained Reduction in Migraine Headache Days</title>
        <description>comparison of MHD recorded in baseline month versus post-treatment months 7, 8 and 9</description>
        <time_frame>1 month of baseline recordation followed by 252 days of device use</time_frame>
        <population>The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.</population>
        <group_list>
          <group group_id="O1">
            <title>BID Placebo</title>
            <description>Participants self-administered twice-daily inactive/sham treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
          <group group_id="O2">
            <title>BID Active</title>
            <description>Participants self-administered twice-daily active treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
          <group group_id="O3">
            <title>QD Active</title>
            <description>Participants self-administered once-daily active treatments for 12 weeks (treatment period 1) followed by once-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
          </group>
        </group_list>
        <measure>
          <title>Sustained Reduction in Migraine Headache Days</title>
          <description>comparison of MHD recorded in baseline month versus post-treatment months 7, 8 and 9</description>
          <population>The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>11 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>BID Placebo</title>
          <description>Participants self-administered twice-daily inactive/sham treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
        </group>
        <group group_id="E2">
          <title>BID Active</title>
          <description>Participants self-administered twice-daily active treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</description>
        </group>
        <group group_id="E3">
          <title>QD Active</title>
          <description>Participants self-administered once-daily active treatments for 12 weeks (treatment period 1) followed by once-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).</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="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Ear discomfort, itch, irritation, pruritis or fullness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="15"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="16"/>
              </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>Dr. Robert Black</name_or_title>
      <organization>Scion NeuroStim, LLC</organization>
      <phone>(919) 260-5528</phone>
      <email>rblack@scionneurostim.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/NCT02991430
org study id: SNS-MIG-02
nct id: NCT02991430
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This study will assess the efficacy of a neuromodulation device for the treatment of episodic
      migraine headache.
This study is a multi-center, triple-blinded, placebo-controlled, randomized clinical trial
      for adjunctive prophylactic treatment of episodic migraine headache (with or without aura)
      using neuromodulation device developed by Scion NeuroStim, LLC (SNS). The investigational use
      of the device for episodic migraine headache has been reviewed by the FDA and is classified
      as NSR (non-significant risk).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in Migraine Headache Days (MHD)
time frame: 1 month of baseline recordation followed by 84 days of device use
description: comparison of MHD recorded in baseline month versus 3rd month of treatment
measure: Normalized Reduction in Migraine Headache Days
time frame: 1 month of baseline recordation followed by 84 days of device use
description: comparison of MHD recorded in baseline month versus 3rd month of treatment: percentages, active versus placebo
measure: Change in Medication Usage
time frame: 1 month of baseline recordation followed by 84 days of device use
description: reduction in acute, prescribed medications in month 3 of treatment versus baseline month
measure: Change in Headache Pain
time frame: 1 month of baseline recordation followed by 84 days of device use
description: reduction in subject perceived headache pain scores in month 3 of treatment versus baseline month
measure: Change in Quality of Life
time frame: 1 month of baseline recordation followed by 84 days of device use
description: comparison of HIT-6 (headache impact test) scores between baseline month and treatment month 3
measure: Change in Depression
time frame: 1 month of baseline recordation followed by 84 days of device use
description: comparison of BDI-II (Beck depression index) scores between baseline month and treatment month 3
measure: Change in Anxiety
time frame: 1 month of baseline recordation followed by 84 days of device use
description: comparison of BAI (Beck anxiety index) scores between baseline month and treatment month 3
measure: Change in Sleep Quality
time frame: 1 month of baseline recordation followed by 84 days of device use
description: comparison of Pittsburgh Sleep assessment scores between baseline month and treatment month 3
measure: Additional Treatment Time
time frame: 1 month of baseline recordation followed by 168 days of device use
description: comparison of MHD recorded in baseline month versus 6th month of treatment
measure: Sustained Reduction in Migraine Headache Days
time frame: 1 month of baseline recordation followed by 252 days of device use
description: comparison of MHD recorded in baseline month versus post-treatment months 7, 8 and 9
arm group label: active
arm group type: Active Comparator
description: active neuromodulation
arm group label: placebo
arm group type: Placebo Comparator
description: placebo neuromodulation
intervention type: Device
intervention name: active neuromodulation for episodic migraine headache
description: Non-invasive brainstem neuromodulator. Active and placebo devices appear identical
arm group label: active
intervention type: Device
intervention name: placebo neuromodulation for episodic migraine headache
description: Sham non-invasive brainstem neuromodulator. Active and placebo devices appear identical
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
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facility: 
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facility: 
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Migraine Disorders
mesh term: Headache
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 