<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/NCT01683019</url>
  </required_header>
  <id_info>
    <org_study_id>NST#002</org_study_id>
    <nct_id>NCT01683019</nct_id>
  </id_info>
  <brief_title>Feasibility Study to Test Clinical Efficacy of Low Energy AC Magnetic Field to Treat Major Depression</brief_title>
  <official_title>A MULTICENTER, RANDOMIZED, BLINDED, SHAM CONTROLLED, PARALLEL GROUP TRIAL TO TEST CLINICAL EFFICACY OF LOW FREQUENCY AC MAGNETIC FIELD INDUCED EEG SYNCHRONIZATION IN MAJOR DEPRESSION</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wave Neuroscience</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wave Neuroscience</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This feasibility study investigates effects of EEG-based low frequency, low emission magnetic&#xD;
      cortical stimulation in comparison to a sham treatment in subjects with moderate to severe&#xD;
      depressive disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Major Depressive Disorder (MDD) is associated with functional impairment and disability, and&#xD;
      results in a significant burden on the affected individual, his or her family, and society in&#xD;
      general. Psychopharmacological therapy has been shown to be effective, but may be accompanied&#xD;
      by significant side effects. The investigators propose an alternative model, based on the&#xD;
      relationship between symptoms, brain metabolism, and neural activity as recorded with&#xD;
      electroencephalography (EEG). Subjects with MDD often have decreased brain metabolism,&#xD;
      accompanied by increased EEG activity in the alpha band. The investigators hypothesis is that&#xD;
      a gentle, non-significant risk, sinusoidal magnetic field above the subject's scalp, which&#xD;
      oscillates at precisely his or her Intrinsic Alpha Frequency (IAF) can take advantage of this&#xD;
      relationship to reduce symptoms without the significant side effects associated with&#xD;
      pharmaceuticals. The investigators propose a 4-week, sham controlled, randomized,&#xD;
      double-blind multi-center feasibility study to determine the efficacy of synchronized low&#xD;
      energy magnetic fields delivered at the subject's IAF to treat MDD. Treatment will be given&#xD;
      concomitant to the subject's existing medication, and will occur 5 days per week at the&#xD;
      clinical site. Target enrollment is 45 adult subjects diagnosed with MDD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2008</start_date>
  <completion_date type="Actual">December 2008</completion_date>
  <primary_completion_date type="Actual">November 2008</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, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment.</measure>
    <time_frame>Assessed at baseline and the end of Week 4 of treatment.</time_frame>
    <description>Outcome measured using the Hamilton Depression Rating Scale (HAMD-17) and calculated as percent change in severity score from baseline until the end of the 4th week of treatment.&#xD;
The HAMD-17 scale ranges between 0-54, with higher numbers indicating more severe symptoms. 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates moderate to severe depression.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Major Depressive Disorder (MDD)</condition>
  <arm_group>
    <arm_group_label>Active Fixed Alpha Frequency Magnetic Stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Random Frequency Magnetic Stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inactive Sham Treatment</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Generate sound similar to active treatment, except that no magnetic field is generated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NeoSync EEG Synchronization Therapy</intervention_name>
    <description>Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks.</description>
    <arm_group_label>Active Fixed Alpha Frequency Magnetic Stimulation</arm_group_label>
    <arm_group_label>Active Random Frequency Magnetic Stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham NeoSync EEG Synchronization Therapy</intervention_name>
    <description>A device that looks and sounds similar to the active treatment, but no magnetic field is generated.</description>
    <arm_group_label>Inactive Sham Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Diagnosis of MDD with HAMD-17 greater than or equal to 17&#xD;
&#xD;
          -  On a stable dose of existing medication or no medication for 1 month or longer prior&#xD;
             to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with another primary Axis I illness&#xD;
&#xD;
          -  Recent history of or current substance abuse&#xD;
&#xD;
          -  Clinically significant medical illness, including any thyroid disorders&#xD;
&#xD;
          -  Known pregnancy and/or lactation, or intent to become pregnant during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Amen Clinic</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Mental Health, Peking University</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <results_first_submitted>October 28, 2013</results_first_submitted>
  <results_first_submitted_qc>April 2, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 5, 2014</results_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>magnetic field</keyword>
  <keyword>alpha frequency</keyword>
  <keyword>EEG</keyword>
  <keyword>NeoSync EEG Synchronization Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited at two separate psychiatric clinics. The recruitment period was between June 9, 2008 and November 5, 2008. Recruitment was accomplished through selection from the normal patient flow at the clinics.</recruitment_details>
      <pre_assignment_details>Following enrollment and completion of informed consent, subjects were randomized to a treatment arm. Subjects were instructed to continue any concomitant medication throughout the treatment period. There was no wash out or transition required.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Active Fixed Alpha Frequency Magnetic Stimulation</title>
          <description>Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).&#xD;
NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Active Random Frequency Magnetic Stimulation</title>
          <description>Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.&#xD;
NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Inactive Sham Treatment</title>
          <description>Generate sound similar to active treatment, except that no magnetic field is generated.&#xD;
Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Active Fixed Alpha Frequency Magnetic Stimulation</title>
          <description>Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).&#xD;
NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Active Random Frequency Magnetic Stimulation</title>
          <description>Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.&#xD;
NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Inactive Sham Treatment</title>
          <description>Generate sound similar to active treatment, except that no magnetic field is generated.&#xD;
Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated.</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="18"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="19"/>
            <count group_id="B4" value="52"/>
          </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="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </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="44.2" spread="15.1"/>
                    <measurement group_id="B2" value="40.7" spread="15.9"/>
                    <measurement group_id="B3" value="46.3" spread="12.7"/>
                    <measurement group_id="B4" value="43.5" spread="14.2"/>
                  </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="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="25"/>
                  </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="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment.</title>
        <description>Outcome measured using the Hamilton Depression Rating Scale (HAMD-17) and calculated as percent change in severity score from baseline until the end of the 4th week of treatment.&#xD;
The HAMD-17 scale ranges between 0-54, with higher numbers indicating more severe symptoms. 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates moderate to severe depression.</description>
        <time_frame>Assessed at baseline and the end of Week 4 of treatment.</time_frame>
        <population>52 subjects were randomized into the study. Of those, 7 dropped in the first week due to difficulties driving to the study site. An intent-to-treat analysis was performed on the remaining 45 subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Active Fixed Alpha Frequency Magnetic Stimulation</title>
            <description>Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).&#xD;
NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Active Random Frequency Magnetic Stimulation</title>
            <description>Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.&#xD;
NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Inactive Sham Treatment</title>
            <description>Generate sound similar to active treatment, except that no magnetic field is generated.&#xD;
Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment.</title>
          <description>Outcome measured using the Hamilton Depression Rating Scale (HAMD-17) and calculated as percent change in severity score from baseline until the end of the 4th week of treatment.&#xD;
The HAMD-17 scale ranges between 0-54, with higher numbers indicating more severe symptoms. 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates moderate to severe depression.</description>
          <population>52 subjects were randomized into the study. Of those, 7 dropped in the first week due to difficulties driving to the study site. An intent-to-treat analysis was performed on the remaining 45 subjects.</population>
          <units>% change in HAM-D score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-53.8" spread="27.8"/>
                    <measurement group_id="O2" value="-53.1" spread="26.9"/>
                    <measurement group_id="O3" value="-24.2" spread="24.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Active Fixed Alpha Frequency Magnetic Stimulation</title>
          <description>Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).&#xD;
NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Active Random Frequency Magnetic Stimulation</title>
          <description>Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.&#xD;
NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Inactive Sham Treatment</title>
          <description>Generate sound similar to active treatment, except that no magnetic field is generated.&#xD;
Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </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. Bill Phillips</name_or_title>
      <organization>NeoSync, Inc.</organization>
      <phone>949-333-2906</phone>
      <email>bill@neosync.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/NCT01683019
org study id: NST#002
nct id: NCT01683019
lead sponsor: 
has dmc: No
is fda regulated device: Yes
This feasibility study investigates effects of EEG-based low frequency, low emission magnetic
      cortical stimulation in comparison to a sham treatment in subjects with moderate to severe
      depressive disorder.
Major Depressive Disorder (MDD) is associated with functional impairment and disability, and
      results in a significant burden on the affected individual, his or her family, and society in
      general. Psychopharmacological therapy has been shown to be effective, but may be accompanied
      by significant side effects. The investigators propose an alternative model, based on the
      relationship between symptoms, brain metabolism, and neural activity as recorded with
      electroencephalography (EEG). Subjects with MDD often have decreased brain metabolism,
      accompanied by increased EEG activity in the alpha band. The investigators hypothesis is that
      a gentle, non-significant risk, sinusoidal magnetic field above the subject's scalp, which
      oscillates at precisely his or her Intrinsic Alpha Frequency (IAF) can take advantage of this
      relationship to reduce symptoms without the significant side effects associated with
      pharmaceuticals. The investigators propose a 4-week, sham controlled, randomized,
      double-blind multi-center feasibility study to determine the efficacy of synchronized low
      energy magnetic fields delivered at the subject's IAF to treat MDD. Treatment will be given
      concomitant to the subject's existing medication, and will occur 5 days per week at the
      clinical site. Target enrollment is 45 adult subjects diagnosed with MDD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment.
time frame: Assessed at baseline and the end of Week 4 of treatment.
description: Outcome measured using the Hamilton Depression Rating Scale (HAMD-17) and calculated as percent change in severity score from baseline until the end of the 4th week of treatment.
The HAMD-17 scale ranges between 0-54, with higher numbers indicating more severe symptoms. 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates moderate to severe depression.
arm group label: Active Fixed Alpha Frequency Magnetic Stimulation
arm group type: Active Comparator
description: Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).
arm group label: Active Random Frequency Magnetic Stimulation
arm group type: Active Comparator
description: Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.
arm group label: Inactive Sham Treatment
arm group type: Sham Comparator
description: Generate sound similar to active treatment, except that no magnetic field is generated.
intervention type: Device
intervention name: NeoSync EEG Synchronization Therapy
description: Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks.
arm group label: Active Fixed Alpha Frequency Magnetic Stimulation
arm group label: Active Random Frequency Magnetic Stimulation
intervention type: Device
intervention name: Sham NeoSync EEG Synchronization Therapy
description: A device that looks and sounds similar to the active treatment, but no magnetic field is generated.
arm group label: Inactive Sham Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: China
country: United States
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 