<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/NCT03277846</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 824349</org_study_id>
    <nct_id>NCT03277846</nct_id>
  </id_info>
  <brief_title>The Safety and Efficacy of Nexalin Trans-cranial Electrical Stimulation Stimulation for the Treatment of Depression</brief_title>
  <acronym>TES</acronym>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Nexalin Electrical Brain Stimulation for the Treatment of Depression in Patients Referred to Electro-Convulsive Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Carrier Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to determine whether Nexalin Trans-Cranial Electrical&#xD;
      Stimulation (TES) is an effective treatment for depression among patients who are candidates&#xD;
      for ECT. A secondary aim to assess whether Nexalin can be used as an alternative to ECT.&#xD;
      Although Nexalin has been approved for use in the US, using Nexalin to treat depression in&#xD;
      this way is investigational and experimental. If Nexalin is found to be an alternative to&#xD;
      ECT, it could offer a safer treatment for depression with less side-effects and a lower cost.&#xD;
&#xD;
      !!! NOTE !!! Post Script / Post Study. The ECT arm (profiling subjects as ECT accepters vs.&#xD;
      rejecters) was dropped owing to site objections by referring clinicians. Accordingly, the&#xD;
      study was framed as a simple comparison between TES and SHAM TES.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A 2x2 factor Randomized Controlled Trial with block randomization. Inpatient subjects at the&#xD;
      Carrier Clinic who are referred for ECT will be recruited, typed regarding their acceptance&#xD;
      of ECT, and randomized to either treatment with TES or to a Sham condition. Treatment&#xD;
      non-responders in either condition will continue as in patients at the Carrier Clinic until&#xD;
      they reach acceptable levels of functioning to be discharged.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">May 17, 2018</completion_date>
  <primary_completion_date type="Actual">May 17, 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>
    <intervention_model_description>A 2x2 factor Randomized Controlled Trial with block randomization</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>All participants and investigators are blind to condition.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment Response</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>Percent responders to TES treatment and Sham TES (50% reduction or a score below 10 on the PHQ-9). The PHQ-9 is a 9 item scale, where each item ranges from 0 to 3. Zero represents &quot;not at all&quot; and 3 represents &quot;nearly every day&quot;. The scale ranges from 0-27. We used percent change (from admission to &quot;ex-take&quot;) as a our metric.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Accept ECT - TES</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Accept ECT where subject is randomized to TES</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Accept ECT - SHAM</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Accept ECT where subject is randomized to a SHAM condition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reject ECT - TES</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reject ECT where subject is randomized to TES</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reject ECT - SHAM</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Reject ECT where subject is randomized to SHAM</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nexalin Based Trans-Cranial Electrical Stimulation</intervention_name>
    <description>The Nexalin device, FDA clearance (501K=K024377, Classification: Stimulator, Cranial Electrotherapy: CFR 882. 5800: U.S. Patent #6904322B2), produces a square waveform that provides trans-cranial electrical stimulation to the brain delivered at a frequency of 77.5 Hz at 0 to 4 mA peak current.</description>
    <arm_group_label>Accept ECT - SHAM</arm_group_label>
    <arm_group_label>Accept ECT - TES</arm_group_label>
    <arm_group_label>Reject ECT - SHAM</arm_group_label>
    <arm_group_label>Reject ECT - TES</arm_group_label>
    <other_name>TES</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. In-patients at the Carrier Clinic&#xD;
&#xD;
          2. Adults over age 18 and under age 65&#xD;
&#xD;
          3. Able to speak, read and write fluently in English, assessed by the study coordinator&#xD;
             at Carrier Clinic&#xD;
&#xD;
          4. Screened Negative for alcohol abuse and/or dependence&#xD;
&#xD;
          5. Able to provide informed consent, assessed by the study coordinator at Carrier Clinic&#xD;
&#xD;
          6. Referred for ECT&#xD;
&#xD;
          7. Not currently taking hypnotics or be prescribed hypnotics during the Nexalin trial&#xD;
&#xD;
          8. Not pregnant or intending to become pregnant during the study&#xD;
&#xD;
          9. Committed to completion of the study&#xD;
&#xD;
        Exclusion Criteria: Medically or psychiatrically unstable, where the severity of the&#xD;
        illness prohibits the subject from engaging in study procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael L Perlis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carrier Clinic</name>
      <address>
        <city>Belle Mead</city>
        <state>New Jersey</state>
        <zip>08502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bestmann S, Walsh V. Transcranial electrical stimulation. Curr Biol. 2017 Dec 4;27(23):R1258-R1262. doi: 10.1016/j.cub.2017.11.001.</citation>
    <PMID>29207262</PMID>
  </reference>
  <reference>
    <citation>Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.</citation>
    <PMID>28709880</PMID>
  </reference>
  <reference>
    <citation>Yavari F, Jamil A, Mosayebi Samani M, Vidor LP, Nitsche MA. Basic and functional effects of transcranial Electrical Stimulation (tES)-An introduction. Neurosci Biobehav Rev. 2018 Feb;85:81-92. doi: 10.1016/j.neubiorev.2017.06.015. Epub 2017 Jul 6.</citation>
    <PMID>28688701</PMID>
  </reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <results_first_submitted>May 7, 2019</results_first_submitted>
  <results_first_submitted_qc>October 4, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 28, 2019</results_first_posted>
  <last_update_submitted>October 4, 2019</last_update_submitted>
  <last_update_submitted_qc>October 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The de-identified data will be shared with our collaborators at Nexalin and Carrier Clinic.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>with 6-18 months</ipd_time_frame>
    <ipd_access_criteria>Only our direct collaborators.</ipd_access_criteria>
  </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>January 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/46/NCT03277846/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Transcranial Electrical Stimulation (Active)</title>
          <description>All subjects get active treatment with Transcranial Electrical Stimulation</description>
        </group>
        <group group_id="P2">
          <title>TES SHAM</title>
          <description>All subjects get SHAM treatment with TES</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Inpatient stay too brief</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Transcranial Electrical Stimulation</title>
          <description>Transcranial Electrical Stimulation (TES). Active Treatment.</description>
        </group>
        <group group_id="B2">
          <title>SHAM -TES</title>
          <description>Sham/placebo condition</description>
        </group>
        <group group_id="B3">
          <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="50"/>
            <count group_id="B2" value="51"/>
            <count group_id="B3" value="101"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="101"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.6" spread="2.4"/>
                    <measurement group_id="B2" value="35.9" spread="2.3"/>
                    <measurement group_id="B3" value="34.2" spread="2.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multi-Racial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Treatment Response</title>
        <description>Percent responders to TES treatment and Sham TES (50% reduction or a score below 10 on the PHQ-9). The PHQ-9 is a 9 item scale, where each item ranges from 0 to 3. Zero represents &quot;not at all&quot; and 3 represents &quot;nearly every day&quot;. The scale ranges from 0-27. We used percent change (from admission to &quot;ex-take&quot;) as a our metric.</description>
        <time_frame>1-2 weeks</time_frame>
        <population>101 were enrolled. 78 subjects were in study for the minimum time / minimum number of treatments and provided the full compliment of data.</population>
        <group_list>
          <group group_id="O1">
            <title>Transcranial Electrical Stimulation</title>
            <description>Transcranial Electrical Stimulation (Active Tx)</description>
          </group>
          <group group_id="O2">
            <title>TES-SHAM</title>
            <description>SHAM treatment (no current). Otherwise procedures identical.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Response</title>
          <description>Percent responders to TES treatment and Sham TES (50% reduction or a score below 10 on the PHQ-9). The PHQ-9 is a 9 item scale, where each item ranges from 0 to 3. Zero represents &quot;not at all&quot; and 3 represents &quot;nearly every day&quot;. The scale ranges from 0-27. We used percent change (from admission to &quot;ex-take&quot;) as a our metric.</description>
          <population>101 were enrolled. 78 subjects were in study for the minimum time / minimum number of treatments and provided the full compliment of data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Transcranial Electrical Stimulation</title>
          <description>TES = Transcranial Electrical Stimulation (active treatment)</description>
        </group>
        <group group_id="E2">
          <title>SHAM-TES</title>
          <description>TES. No current. Procedures were otherwise identical between conditions</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="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </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="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </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>Michael Perlis</name_or_title>
      <organization>University of Pennsylvania</organization>
      <phone>215-746-3577</phone>
      <email>mperlis@upenn.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03277846
org study id: IRB 824349
nct id: NCT03277846
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this research study is to determine whether Nexalin Trans-Cranial Electrical
      Stimulation (TES) is an effective treatment for depression among patients who are candidates
      for ECT. A secondary aim to assess whether Nexalin can be used as an alternative to ECT.
      Although Nexalin has been approved for use in the US, using Nexalin to treat depression in
      this way is investigational and experimental. If Nexalin is found to be an alternative to
      ECT, it could offer a safer treatment for depression with less side-effects and a lower cost.

      !!! NOTE !!! Post Script / Post Study. The ECT arm (profiling subjects as ECT accepters vs.
      rejecters) was dropped owing to site objections by referring clinicians. Accordingly, the
      study was framed as a simple comparison between TES and SHAM TES.
A 2x2 factor Randomized Controlled Trial with block randomization. Inpatient subjects at the
      Carrier Clinic who are referred for ECT will be recruited, typed regarding their acceptance
      of ECT, and randomized to either treatment with TES or to a Sham condition. Treatment
      non-responders in either condition will continue as in patients at the Carrier Clinic until
      they reach acceptable levels of functioning to be discharged.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A 2x2 factor Randomized Controlled Trial with block randomization
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: All participants and investigators are blind to condition.
measure: Treatment Response
time frame: 1-2 weeks
description: Percent responders to TES treatment and Sham TES (50% reduction or a score below 10 on the PHQ-9). The PHQ-9 is a 9 item scale, where each item ranges from 0 to 3. Zero represents "not at all" and 3 represents "nearly every day". The scale ranges from 0-27. We used percent change (from admission to "ex-take") as a our metric.
arm group label: Accept ECT - TES
arm group type: Experimental
description: Accept ECT where subject is randomized to TES
arm group label: Accept ECT - SHAM
arm group type: Placebo Comparator
description: Accept ECT where subject is randomized to a SHAM condition
arm group label: Reject ECT - TES
arm group type: Experimental
description: Reject ECT where subject is randomized to TES
arm group label: Reject ECT - SHAM
arm group type: Placebo Comparator
description: Reject ECT where subject is randomized to SHAM
intervention type: Device
intervention name: Nexalin Based Trans-Cranial Electrical Stimulation
description: The Nexalin device, FDA clearance (501K=K024377, Classification: Stimulator, Cranial Electrotherapy: CFR 882. 5800: U.S. Patent #6904322B2), produces a square waveform that provides trans-cranial electrical stimulation to the brain delivered at a frequency of 77.5 Hz at 0 to 4 mA peak current.
arm group label: Accept ECT - SHAM
arm group label: Accept ECT - TES
arm group label: Reject ECT - SHAM
arm group label: Reject ECT - TES
other name: TES
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Michael L Perlis, PhD
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
citation: Bestmann S, Walsh V. Transcranial electrical stimulation. Curr Biol. 2017 Dec 4;27(23):R1258-R1262. doi: 10.1016/j.cub.2017.11.001.
PMID: 29207262
citation: Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.
PMID: 28709880
citation: Yavari F, Jamil A, Mosayebi Samani M, Vidor LP, Nitsche MA. Basic and functional effects of transcranial Electrical Stimulation (tES)-An introduction. Neurosci Biobehav Rev. 2018 Feb;85:81-92. doi: 10.1016/j.neubiorev.2017.06.015. Epub 2017 Jul 6.
PMID: 28688701
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: Yes
ipd description: The de-identified data will be shared with our collaborators at Nexalin and Carrier Clinic.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: with 6-18 months
ipd access criteria: Only our direct collaborators.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 