<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/NCT02981381</url>
  </required_header>
  <id_info>
    <org_study_id>2016-004</org_study_id>
    <secondary_id>1010584-1</secondary_id>
    <nct_id>NCT02981381</nct_id>
  </id_info>
  <brief_title>Synchronized Transcranial Magnetic Stimulation for PTSD</brief_title>
  <acronym>sTMS</acronym>
  <official_title>Synchronized TMS for Posttraumatic Stress Disorder and Comorbid Depressive Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Providence VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wave Neuroscience</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Providence VA Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators propose a small, two-site, sham-controlled pilot study of synchronized&#xD;
      Transcranial Magnetic Stimulation (sTMS) in patients with comorbid post-traumatic stress&#xD;
      disorder (PTSD) and depression. It is hypothesized that sTMS will be effective for PTSD and&#xD;
      mood symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Posttraumatic stress disorder (PTSD) is a highly prevalent psychiatric disorder associated&#xD;
      with high degrees of comorbidity (e.g., major depressive disorder), poor quality of life, and&#xD;
      significant social and occupational dysfunction. Currently available evidence-based&#xD;
      pharmacological and psychological treatments for PTSD have only modest efficacy, and thus&#xD;
      further research is necessary to develop treatment approaches in order to ameliorate the&#xD;
      current disparity between disorder impact and prevalence, and effective therapies.&#xD;
&#xD;
      The use of non-invasive neuromodulation techniques, such as repetitive transcranial magnetic&#xD;
      stimulation (rTMS), in an outpatient setting, has shown to be effective in reducing symptoms&#xD;
      in various mental disorders, including PTSD and major depressive disorder (MDD). Research&#xD;
      examining the use of rTMS for PTSD still remain limited, the majority of findings pertain to&#xD;
      rTMS in MDD cohorts, which excluded individuals with PTSD. Given the high rate of PTSD with&#xD;
      MDD comorbidity, additional studies examining this comorbid population are necessary.&#xD;
&#xD;
      Furthermore, rTMS treatment parameters and duration are rather time consuming for patients,&#xD;
      requiring that patient travel to an outpatient facility daily, for 6 to 8 weeks, for 30 to 40&#xD;
      minutes each day. This can be an inconvenience and poses an additional burden for individuals&#xD;
      that already struggle with societal integration and social/occupational dysfunction. Thus,&#xD;
      further exploration and development of non-invasive brain stimulatory devices with the same&#xD;
      (or better) effectiveness as rTMS, that can be adapted to be utilized in an at home setting,&#xD;
      would revolutionize the treatment of PTSD.&#xD;
&#xD;
      The synchronized transcranial magnetic stimulation (sTMS, NeoSync Inc.) device provides the&#xD;
      possibility of the fore mentioned therapeutic development. The sTMS device employs 3&#xD;
      transversely rotating, to deliver low energy, sinusoidal magnetic fields synchronized to an&#xD;
      individuals' intrinsic alpha frequency (IAF). Preliminary data has shown that sTMS can&#xD;
      effectively reduce depressive symptoms in MDD. Additionally, the investigators' preliminary&#xD;
      examination of IAF in participants with comorbid PTSD and depressive symptoms, has&#xD;
      illuminated the feasibility of this modality as a treatment approach for PTSD comorbid with&#xD;
      MDD.&#xD;
&#xD;
      This study is a prospective, sham-controlled, trial of sTMS delivered to patients who are&#xD;
      symptomatic despite ongoing pharmacotherapy for PTSD and mood symptoms. Eligible subjects&#xD;
      will be randomized using to receive 4 weeks (5 daily sessions per week) of either sham or&#xD;
      active sTMS treatment. Clinical and self-report assessments will be completed at baseline,&#xD;
      sham/control series endpoint, and 1 month after the final treatment session. An optional&#xD;
      open-label continuation phase will be offered to all study participants who complete the&#xD;
      sham-control phase of this study, and additional endpoint assessments will be administered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 13, 2016</start_date>
  <completion_date type="Actual">October 26, 2018</completion_date>
  <primary_completion_date type="Actual">October 26, 2018</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PCL-5 Total Score Change</measure>
    <time_frame>Through Study Completion (up to 2 years)</time_frame>
    <description>The PTSD checklist (PCL-5) will be used to assess PTSD symptom severity pre- and post-treatment. The change in total PCL-5 score from Baseline (Day 0) to endpoint (PT1) compared between active treatment and sham-controlled groups. If a participant does not complete PT1, last observation carried forward (LOCF) will be used. A 50% reduction in scores from Baseline scores to PT1 indicates clinical response to treatment (active sTMS vs. sham), and remission is defined by a post-treatment score below the threshold score published for the PCL-5.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>QIDS-SR Total Score Change: Clinical Response</measure>
    <time_frame>Through Study Completion (up to 2 years)</time_frame>
    <description>The Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR) is a 16 question self-rating assessment of depressive symptom severity. Pre- and post-treatment scores on the QIDS-SR will be analyzed and reported in a descriptive manner for the sample. Categorical response (empirically defined as 50% decrease from pre-treatment baseline) and remission (below threshold score, per published standards for each scale) at endpoint will be calculated and reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship between Intrinsic Alpha Frequency (IAF) and treatment outcomes</measure>
    <time_frame>Through Study Completion (up to 2 years)</time_frame>
    <description>TMS will be synchronized to the Individual Alpha Frequency (IAF) of each participant, calculated using electroencephalography (EEG) prior to the first treatment. The relationship between mean IAF at baseline and treatment outcomes (i.e., change in total symptom severity) will be analyzed and reported for both groups, at PT1 and open-label continuation endpoint (OL PT1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Event or Unexpected Side Effects: Safety Endpoint</measure>
    <time_frame>2 years</time_frame>
    <description>Unexpected side effects and adverse events will be descriptively reported to analyze sTMS safety efficacy. The investigators will follow Institutional Review Board (IRB) guidelines for reporting significant and unexpected adverse events.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>PTSD</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Active sTMS (NEST-1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized to this group will receive 20 active synchronized Transcranial Magnetic Stimulation (sTMS) treatments (30 minutes each) over a period of 40 calendar days. Treatment windows will be 10 calendar days to complete 5 active sTMS sessions. Serial assessments will be completed every 5 sessions. Post-treatment (PT1) endpoint assessments will take place on the last day of active sTMS.&#xD;
Participants that elect to participate in the open-label continuation phase, will receive an additional 20 sTMS treatments (using the NEST-2 device), following the same administration structure as the sham-control series.&#xD;
Participants will return to complete post-treatment follow-up assessments (PT2) 1 month after their last treatment session (either PT1 or OL PT1).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham sTMS (SHAM)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Subjects randomized to this group will receive 20 sham synchronized Transcranial Magnetic Stimulation (sTMS) treatments (30 minutes each) over a period of 40 calendar days. Treatment windows will be 10 calendar days to complete 5 sham sessions. Serial assessments will be completed every 5 sessions. Post-treatment (PT1) endpoint assessments will take place immediately after the final sham session.&#xD;
Participants that elect to participate in the open-label continuation phase, will receive 20 sTMS treatments (using the NEST-2 device), following the same administration structure as the sham-control series.&#xD;
Participants will return to complete post-treatment follow-up assessments (PT2) 1 month after their last treatment session (either PT1 or OL PT1).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NEST-1</intervention_name>
    <description>The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of PTSD. The device includes an EEG recording module that is used to record individualized alpha frequency (IAF) on randomized personal passport modules (PPM) pre-assigned to be NEST-1 compatible.</description>
    <arm_group_label>Active sTMS (NEST-1)</arm_group_label>
    <other_name>Active sTMS</other_name>
    <other_name>NeoSync EEG Synchronized TMS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SHAM</intervention_name>
    <description>The SHAM NeoSync EEG Synchronized TMS (NEST) is a device, identical to the active NEST-1 device, that is configured to simulate the delivery of active treatment without actively delivering sTMS therapy. The device includes an EEG recording module that is used to record individualized alpha frequency (IAF) on randomized personal passport modules (PPM) pre-assigned to be SHAM compatible.</description>
    <arm_group_label>Sham sTMS (SHAM)</arm_group_label>
    <other_name>NEST-1 Sham Comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NEST-2</intervention_name>
    <description>The open-label NeoSync EEG Synchronized TMS (NEST) that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of PTSD. The device is distinct in both color and sound both SHAM and NEST-1 devices. PPMs corresponding with both SHAM and NEST-1 devices are compatible with the NEST-2 device.</description>
    <arm_group_label>Active sTMS (NEST-1)</arm_group_label>
    <arm_group_label>Sham sTMS (SHAM)</arm_group_label>
    <other_name>Open-label sTMS</other_name>
    <other_name>NeoSync EEG Synchronized TMS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be a Veteran;&#xD;
&#xD;
          -  MRI safe;&#xD;
&#xD;
          -  Meet Diagnostic and Statistical Manual, Fifth Edition (DSM 5) criterion for PTSD&#xD;
             (acute or chronic, confirmed by the Clinician Administered PTSD Scale (CAPS) and at&#xD;
             least moderate severity defined by a PCL-5 score &gt; 33); AND at least moderate&#xD;
             depressive symptom severity (defined by QIDS-SR score &gt; or equal to 11) at baseline&#xD;
             visit. Individuals with bipolar II or otherwise unspecified who are currently in a&#xD;
             depressed episode are eligible;&#xD;
&#xD;
          -  Baseline score of &quot;moderately ill&quot; or worse on the Clinical Global&#xD;
             Impressions-Severity (CGI-S);&#xD;
&#xD;
          -  Stable psychotropic regimen for at least 6 weeks prior to baseline and willing to&#xD;
             maintain current dose and regimen throughout study, or no psychotropic medication at&#xD;
             all;&#xD;
&#xD;
          -  If female and of child bearing potential, must agree to use an acceptable method of&#xD;
             birth control for the duration of the study treatment period;&#xD;
&#xD;
          -  Be willing and able to comply with all study related procedures and visits;&#xD;
&#xD;
          -  Be capable of independently reading and understanding all patient information&#xD;
             materials and giving written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating, or planning on becoming pregnant within the next 3 months;&#xD;
&#xD;
          -  Lifetime history of loss of consciousness (&gt;10 minutes) due to head injury, or&#xD;
             lifetime history of head injury with documented evidence of brain injury;&#xD;
&#xD;
          -  Current (or past) significant neurological disorders (seizure disorder, primary or&#xD;
             secondary central nervous system (CNS) tumors, stroke, cerebral aneurysm);&#xD;
&#xD;
          -  Unstable medical illness, or significant absence of appropriate medical care;&#xD;
&#xD;
          -  Current axis I primary psychotic disorder or Bipolar I disorder;&#xD;
&#xD;
          -  Active (within the last month) moderate or severe substance (excluding&#xD;
             nicotine/caffeine) abuse disorders. Individuals on stable (&gt;3 months), monitored&#xD;
             opiate agonist therapy may be included at investigator's discretion;&#xD;
&#xD;
          -  Past failed treatment with rTMS or electroconvulsive therapy (ECT); any past treatment&#xD;
             with deep brain stimulation or vagus nerve stimulation;&#xD;
&#xD;
          -  Have an active suicidal intent or plan, or in the opinion of the investigator, is&#xD;
             likely to attempt suicide in the next 6 months;&#xD;
&#xD;
          -  Presence of condition or circumstance with potential to prevent study completion;&#xD;
&#xD;
          -  Inability to obtain sufficient EEG to calibrate study device.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Noah S Philip, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Study Principal Investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Providence VAMC</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>White River Junction VAMC</name>
      <address>
        <city>White River Junction</city>
        <state>Vermont</state>
        <zip>05009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>October 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Providence VA Medical Center</investigator_affiliation>
    <investigator_full_name>Noah S. Philip, MD</investigator_full_name>
    <investigator_title>Psychiatrist</investigator_title>
  </responsible_party>
  <keyword>sTMS</keyword>
  <keyword>NeoSync</keyword>
  <keyword>NEST</keyword>
  <keyword>synchronous</keyword>
  <keyword>non-invasive neuromodulation</keyword>
  <keyword>TMS</keyword>
  <keyword>Transcranial Magnetic Stimulation</keyword>
  <keyword>PTSD</keyword>
  <keyword>EEG</keyword>
  <keyword>Depression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02981381
org study id: 2016-004
secondary id: 1010584-1
nct id: NCT02981381
lead sponsor: 
collaborator: 
has dmc: No
The investigators propose a small, two-site, sham-controlled pilot study of synchronized
      Transcranial Magnetic Stimulation (sTMS) in patients with comorbid post-traumatic stress
      disorder (PTSD) and depression. It is hypothesized that sTMS will be effective for PTSD and
      mood symptoms.
Posttraumatic stress disorder (PTSD) is a highly prevalent psychiatric disorder associated
      with high degrees of comorbidity (e.g., major depressive disorder), poor quality of life, and
      significant social and occupational dysfunction. Currently available evidence-based
      pharmacological and psychological treatments for PTSD have only modest efficacy, and thus
      further research is necessary to develop treatment approaches in order to ameliorate the
      current disparity between disorder impact and prevalence, and effective therapies.

      The use of non-invasive neuromodulation techniques, such as repetitive transcranial magnetic
      stimulation (rTMS), in an outpatient setting, has shown to be effective in reducing symptoms
      in various mental disorders, including PTSD and major depressive disorder (MDD). Research
      examining the use of rTMS for PTSD still remain limited, the majority of findings pertain to
      rTMS in MDD cohorts, which excluded individuals with PTSD. Given the high rate of PTSD with
      MDD comorbidity, additional studies examining this comorbid population are necessary.

      Furthermore, rTMS treatment parameters and duration are rather time consuming for patients,
      requiring that patient travel to an outpatient facility daily, for 6 to 8 weeks, for 30 to 40
      minutes each day. This can be an inconvenience and poses an additional burden for individuals
      that already struggle with societal integration and social/occupational dysfunction. Thus,
      further exploration and development of non-invasive brain stimulatory devices with the same
      (or better) effectiveness as rTMS, that can be adapted to be utilized in an at home setting,
      would revolutionize the treatment of PTSD.

      The synchronized transcranial magnetic stimulation (sTMS, NeoSync Inc.) device provides the
      possibility of the fore mentioned therapeutic development. The sTMS device employs 3
      transversely rotating, to deliver low energy, sinusoidal magnetic fields synchronized to an
      individuals' intrinsic alpha frequency (IAF). Preliminary data has shown that sTMS can
      effectively reduce depressive symptoms in MDD. Additionally, the investigators' preliminary
      examination of IAF in participants with comorbid PTSD and depressive symptoms, has
      illuminated the feasibility of this modality as a treatment approach for PTSD comorbid with
      MDD.

      This study is a prospective, sham-controlled, trial of sTMS delivered to patients who are
      symptomatic despite ongoing pharmacotherapy for PTSD and mood symptoms. Eligible subjects
      will be randomized using to receive 4 weeks (5 daily sessions per week) of either sham or
      active sTMS treatment. Clinical and self-report assessments will be completed at baseline,
      sham/control series endpoint, and 1 month after the final treatment session. An optional
      open-label continuation phase will be offered to all study participants who complete the
      sham-control phase of this study, and additional endpoint assessments will be administered.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: PCL-5 Total Score Change
time frame: Through Study Completion (up to 2 years)
description: The PTSD checklist (PCL-5) will be used to assess PTSD symptom severity pre- and post-treatment. The change in total PCL-5 score from Baseline (Day 0) to endpoint (PT1) compared between active treatment and sham-controlled groups. If a participant does not complete PT1, last observation carried forward (LOCF) will be used. A 50% reduction in scores from Baseline scores to PT1 indicates clinical response to treatment (active sTMS vs. sham), and remission is defined by a post-treatment score below the threshold score published for the PCL-5.
measure: QIDS-SR Total Score Change: Clinical Response
time frame: Through Study Completion (up to 2 years)
description: The Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR) is a 16 question self-rating assessment of depressive symptom severity. Pre- and post-treatment scores on the QIDS-SR will be analyzed and reported in a descriptive manner for the sample. Categorical response (empirically defined as 50% decrease from pre-treatment baseline) and remission (below threshold score, per published standards for each scale) at endpoint will be calculated and reported.
measure: Relationship between Intrinsic Alpha Frequency (IAF) and treatment outcomes
time frame: Through Study Completion (up to 2 years)
description: TMS will be synchronized to the Individual Alpha Frequency (IAF) of each participant, calculated using electroencephalography (EEG) prior to the first treatment. The relationship between mean IAF at baseline and treatment outcomes (i.e., change in total symptom severity) will be analyzed and reported for both groups, at PT1 and open-label continuation endpoint (OL PT1).
measure: Number of Participants with Adverse Event or Unexpected Side Effects: Safety Endpoint
time frame: 2 years
description: Unexpected side effects and adverse events will be descriptively reported to analyze sTMS safety efficacy. The investigators will follow Institutional Review Board (IRB) guidelines for reporting significant and unexpected adverse events.
arm group label: Active sTMS (NEST-1)
arm group type: Experimental
description: Subjects randomized to this group will receive 20 active synchronized Transcranial Magnetic Stimulation (sTMS) treatments (30 minutes each) over a period of 40 calendar days. Treatment windows will be 10 calendar days to complete 5 active sTMS sessions. Serial assessments will be completed every 5 sessions. Post-treatment (PT1) endpoint assessments will take place on the last day of active sTMS.
Participants that elect to participate in the open-label continuation phase, will receive an additional 20 sTMS treatments (using the NEST-2 device), following the same administration structure as the sham-control series.
Participants will return to complete post-treatment follow-up assessments (PT2) 1 month after their last treatment session (either PT1 or OL PT1).
arm group label: Sham sTMS (SHAM)
arm group type: Sham Comparator
description: Subjects randomized to this group will receive 20 sham synchronized Transcranial Magnetic Stimulation (sTMS) treatments (30 minutes each) over a period of 40 calendar days. Treatment windows will be 10 calendar days to complete 5 sham sessions. Serial assessments will be completed every 5 sessions. Post-treatment (PT1) endpoint assessments will take place immediately after the final sham session.
Participants that elect to participate in the open-label continuation phase, will receive 20 sTMS treatments (using the NEST-2 device), following the same administration structure as the sham-control series.
Participants will return to complete post-treatment follow-up assessments (PT2) 1 month after their last treatment session (either PT1 or OL PT1).
intervention type: Device
intervention name: NEST-1
description: The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of PTSD. The device includes an EEG recording module that is used to record individualized alpha frequency (IAF) on randomized personal passport modules (PPM) pre-assigned to be NEST-1 compatible.
arm group label: Active sTMS (NEST-1)
other name: Active sTMS
other name: NeoSync EEG Synchronized TMS
intervention type: Device
intervention name: SHAM
description: The SHAM NeoSync EEG Synchronized TMS (NEST) is a device, identical to the active NEST-1 device, that is configured to simulate the delivery of active treatment without actively delivering sTMS therapy. The device includes an EEG recording module that is used to record individualized alpha frequency (IAF) on randomized personal passport modules (PPM) pre-assigned to be SHAM compatible.
arm group label: Sham sTMS (SHAM)
other name: NEST-1 Sham Comparator
intervention type: Device
intervention name: NEST-2
description: The open-label NeoSync EEG Synchronized TMS (NEST) that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of PTSD. The device is distinct in both color and sound both SHAM and NEST-1 devices. PPMs corresponding with both SHAM and NEST-1 devices are compatible with the NEST-2 device.
arm group label: Active sTMS (NEST-1)
arm group label: Sham sTMS (SHAM)
other name: Open-label sTMS
other name: NeoSync EEG Synchronized TMS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Noah S Philip, MD
role: Principal Investigator
affiliation: Study Principal Investigator
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Providence VA Medical Center
investigator full name: Noah S. Philip, MD
investigator title: Psychiatrist
mesh term: Depression
sharing ipd: No