<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/NCT03819543</url>
  </required_header>
  <id_info>
    <org_study_id>B2018:133</org_study_id>
    <nct_id>NCT03819543</nct_id>
  </id_info>
  <brief_title>SURESTEP: Transcranial Direct Current Stimulation in Super Refractory Status Epilepticus</brief_title>
  <acronym>SURESTEP</acronym>
  <official_title>Transcranial Direct Current Stimulation in SUper REfractory STatus EPilepticus (SURESTEP): Pilot Study of a Novel Therapy in a Common Medical Emergency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Manitoba Medical Service Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Manitoba</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether transcranial direct current stimulation&#xD;
      affects super refractory status epilepticus.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID-19&#xD;
  </why_stopped>
  <start_date type="Actual">July 15, 2019</start_date>
  <completion_date type="Actual">August 31, 2021</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of Epileptiform Activity, Per Patient-based</measure>
    <time_frame>Up to 3 hours per EEG recording</time_frame>
    <description>EEG epileptiform activity as defined in units of spikes per second for a given patient. Pre-stim compares spike rates during stimulation to before stimulation. Pre-post compares spike rates after stimulation to before stimulation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of Epileptiform Activity, Per-session Based</measure>
    <time_frame>Up to 3 hours per EEG recording</time_frame>
    <description>EEG epileptiform activity as defined in units of spikes per second for a given stimulation session. Pre-stim compares spike rates during stimulation to before stimulation. Pre-post compares spike rates after stimulation to before stimulation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Status Epilepticus</condition>
  <arm_group>
    <arm_group_label>Transcranial Direct Current Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial Direct Current Stimulation</intervention_name>
    <description>Application of transcranial direct current stimulation via scalp electrodes over presumed epileptogenic focus for 20 minutes at 2.0 mA.</description>
    <arm_group_label>Transcranial Direct Current Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of super refractory status epilepticus&#xD;
&#xD;
          -  admitted to the intensive care unit&#xD;
&#xD;
          -  identifiable epileptogenic focus on EEG&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindications to scalp EEG&#xD;
&#xD;
          -  lice&#xD;
&#xD;
          -  scabies&#xD;
&#xD;
          -  other hair/skin infection&#xD;
&#xD;
          -  scalp psoriasis&#xD;
&#xD;
          -  hypersensitivity&#xD;
&#xD;
          -  other severe dermatological condition&#xD;
&#xD;
          -  previous adverse reaction to collodion&#xD;
&#xD;
          -  vagal nerve stimulator&#xD;
&#xD;
          -  implantable cardioverter defibrillator&#xD;
&#xD;
          -  cardiac pacemaker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcus Ng, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Health Sciences Centre</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3A1R9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <results_first_submitted>November 1, 2022</results_first_submitted>
  <results_first_submitted_qc>January 19, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 16, 2023</results_first_posted>
  <last_update_submitted>January 19, 2023</last_update_submitted>
  <last_update_submitted_qc>January 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2023</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>Status Epilepticus</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03819543/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Transcranial Direct Current Stimulation</title>
          <description>Patients receiving transcranial direct current stimulation</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Transcranial Direct Current Stimulation</title>
          <description>Patients receiving transcranial direct current stimulation</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>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="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </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="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Frequency of Epileptiform Activity, Per Patient-based</title>
        <description>EEG epileptiform activity as defined in units of spikes per second for a given patient. Pre-stim compares spike rates during stimulation to before stimulation. Pre-post compares spike rates after stimulation to before stimulation.</description>
        <time_frame>Up to 3 hours per EEG recording</time_frame>
        <population>Automated and human counting methods found differing numbers of spikes between patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Transcranial Direct Current Stimulation</title>
            <description>Patients receiving transcranial direct current stimulation</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Epileptiform Activity, Per Patient-based</title>
          <description>EEG epileptiform activity as defined in units of spikes per second for a given patient. Pre-stim compares spike rates during stimulation to before stimulation. Pre-post compares spike rates after stimulation to before stimulation.</description>
          <population>Automated and human counting methods found differing numbers of spikes between patients.</population>
          <units>percentage reduction in spikes/sec</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-Stim Change (Automated Counts)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-45.9" lower_limit="-59" upper_limit="-11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-Stim Change (Human Counts)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-51.6" lower_limit="-70.2" upper_limit="-17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-Post Change (Automated Counts)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.3" lower_limit="-25.4" upper_limit="-1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-Post Change (Human Counts)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.3" lower_limit="-42.6" upper_limit="-15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Epileptiform Activity, Per-session Based</title>
        <description>EEG epileptiform activity as defined in units of spikes per second for a given stimulation session. Pre-stim compares spike rates during stimulation to before stimulation. Pre-post compares spike rates after stimulation to before stimulation.</description>
        <time_frame>Up to 3 hours per EEG recording</time_frame>
        <population>Automated and human counting methods found differing numbers of spikes between patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Transcranial Direct Current Stimulation</title>
            <description>Patients receiving transcranial direct current stimulation</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Epileptiform Activity, Per-session Based</title>
          <description>EEG epileptiform activity as defined in units of spikes per second for a given stimulation session. Pre-stim compares spike rates during stimulation to before stimulation. Pre-post compares spike rates after stimulation to before stimulation.</description>
          <population>Automated and human counting methods found differing numbers of spikes between patients.</population>
          <units>percentage reduction in spikes/sec</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <units_analyzed>Sessions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Sessions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-Stim Change (Automated Counts)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sessions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-47.2" lower_limit="-76.8" upper_limit="-16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-Stim Change (Human Counts)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sessions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-38.5" lower_limit="-79.7" upper_limit="-4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-Post Change (Automated Counts)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sessions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.8" lower_limit="-48.7" upper_limit="21.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-Post Change (Human Counts)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sessions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.8" lower_limit="-61.4" upper_limit="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>through study completion, an average of 251.1 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Transcranial Direct Current Stimulation</title>
          <description>Transcranial Direct Current Stimulation: Application of transcranial direct current stimulation via scalp electrodes over presumed epileptogenic focus for 20 minutes at 2.0 mA.</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="7" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Marcus Ng</name_or_title>
      <organization>University of Manitoba</organization>
      <phone>204-787-2684</phone>
      <email>marcus.ng@umanitoba.ca</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/NCT03819543
org study id: B2018:133
nct id: NCT03819543
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study is to determine whether transcranial direct current stimulation
      affects super refractory status epilepticus.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Frequency of Epileptiform Activity, Per Patient-based
time frame: Up to 3 hours per EEG recording
description: EEG epileptiform activity as defined in units of spikes per second for a given patient. Pre-stim compares spike rates during stimulation to before stimulation. Pre-post compares spike rates after stimulation to before stimulation.
measure: Frequency of Epileptiform Activity, Per-session Based
time frame: Up to 3 hours per EEG recording
description: EEG epileptiform activity as defined in units of spikes per second for a given stimulation session. Pre-stim compares spike rates during stimulation to before stimulation. Pre-post compares spike rates after stimulation to before stimulation.
arm group label: Transcranial Direct Current Stimulation
arm group type: Experimental
intervention type: Device
intervention name: Transcranial Direct Current Stimulation
description: Application of transcranial direct current stimulation via scalp electrodes over presumed epileptogenic focus for 20 minutes at 2.0 mA.
arm group label: Transcranial Direct Current Stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marcus Ng, MD
role: Principal Investigator
affiliation: University of Manitoba
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Status Epilepticus
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 