<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/NCT03795051</url>
  </required_header>
  <id_info>
    <org_study_id>MGS-2018-SS</org_study_id>
    <nct_id>NCT03795051</nct_id>
  </id_info>
  <brief_title>Coil Positioning in Navigated Transcranial Magnetic Stimulation Feasibility in Depression Patients Trial</brief_title>
  <acronym>CONFIDENT</acronym>
  <official_title>Precise Coil Positioning in Navigated Transcranial Magnetic Stimulation (nTMS) in Medication- Resistant Major Depressive Disorder (MDD): A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Magstim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Magstim</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the feasibility of adding a navigational system to&#xD;
      traditional repetitive Transcranial Magnetic Stimulation (rTMS, referred to in this&#xD;
      application as nTMS) as a way to establish and maintain precise coil positioning (contact,&#xD;
      rotation, and tilt) and consistent brain region targeting throughout a nTMS treatment session&#xD;
      and in subsequent nTMS sessions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: The objective of this study is to evaluate the feasibility of adding a&#xD;
      navigational system to traditional repetitive Transcranial Magnetic Stimulation (rTMS,&#xD;
      referred to in this application as nTMS) as a way to establish and maintain precise coil&#xD;
      positioning (contact, rotation, and tilt) and consistent brain region targeting throughout a&#xD;
      nTMS treatment session and in subsequent nTMS sessions. Success will be evaluated via data&#xD;
      analysis of information captured during nTMS, which will evaluate coordinates, contact,&#xD;
      rotation, and tilt parameters of the stimulation pulses delivered. The study will be&#xD;
      conducted with patients who have been selected as traditional rTMS candidates and have met&#xD;
      the criteria for rTMS, which includes, but is not limited to the following: Adults with Major&#xD;
      Depressive Disorder (MDD) who have failed to achieve satisfactory improvement from prior&#xD;
      antidepressant medication in the current episode. For the purposes of this study, nTMS is&#xD;
      referring to the use of a navigation device in combination with delivery of traditional rTMS.&#xD;
&#xD;
      Aim 1: Determine the percentage of successful nTMS treatment sessions. A successful nTMS&#xD;
      treatment session is defined as the following: 80% of the TMS pulse trains are delivered&#xD;
      while the coil is within acceptance criteria measured by tracking the following parameters:&#xD;
      coil deviations from digitally saved target location, which includes contact (mm), rotation&#xD;
      (°), and tilt (°) parameters. The acceptance criteria are met with coil position at the time&#xD;
      of pulse delivery as follows: coil rotation within ±15° of target; coil tilt within ±15° of&#xD;
      target; in-plane deviation within ±5mm of target; contact deviation within ±2mm of target.&#xD;
&#xD;
      Aim 2: Determine Patient Health Questionnaire (PHQ-9) change measured weekly from baseline to&#xD;
      after 30 sessions of nTMS, collect Patient comfort data, measure Operator confidence and&#xD;
      collect coil position data for nTMS sessions to determine future product improvements and&#xD;
      clinical studies.&#xD;
&#xD;
      The goal of this proposal is to establish nTMS as a means of precise administration of&#xD;
      transcranial magnetic stimulation. Ultimately, data from this study will be used to design&#xD;
      larger, comparative studies to establish superior efficacy profiles in the treatment of MDD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2019</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</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>Percentage of successful nTMS treatment sessions</measure>
    <time_frame>The number of successful treatment sessions will be assessed after 6 weeks of treatment. Only data from week 2 through 6 will be included (approximately 25 treatment sessions). (Example 20 out of 25 sessions were successful.)</time_frame>
    <description>The primary outcome measure will be the percentage of successful nTMS treatment sessions pooled from sessions 6 through 30 for each study subject. A successful nTMS treatment session is defined as: 80% of the TMS pulse trains are delivered while the coil is within acceptance criteria measured by tracking the following parameters: coil deviations from digitally saved target location, which includes contact (mm), rotation (°), and tilt (°) parameters. The acceptance criteria are met with coil position at the time of pulse delivery as follows: coil rotation within ±15° of target; coil tilt within ±15° of target; in-plane deviation within ±5mm of target; contact deviation within ±2mm of target.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operator Confidence</measure>
    <time_frame>Aproximately 5 months after first patient treatment. After last study patient at site has completed the treatment or has exited the study (expected for May 2019).</time_frame>
    <description>Operator confidence will be measured on a scale of 1 to 5; 1 being not confident at all in using StimGuide to consistently find the treatment site and deliver therapy to 5 being very confident in using StimGuide to consistently find the treatment site and deliver therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Comfort</measure>
    <time_frame>After last treatment has been completed; approximately six week after treatment start</time_frame>
    <description>Patient comfort measured on a scale from 1 to 5; with 1 being uncomfortable and 5 being extremely comfortable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire 9 (PHQ-9) - Patient Depression Questionnaire</measure>
    <time_frame>At baseline and after six weeks of treatment</time_frame>
    <description>Patient Health Questionnaire (PHQ-9) change from baseline. The PHQ-9 Patient Depression Questionnaire has 9 questions with a scale range for each question of 0 to 3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day. The maximum summed score (severely depressed) is 27.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coil Position deviation from target</measure>
    <time_frame>Coil position deviation: every treatment session during week 2 through 6</time_frame>
    <description>Coil deviation for every pulse train for each patient's nTMS session. Coil deviations from digitally saved target location, which includes contact (mm), rotation (°), and tilt (°) parameters will be measured and reported.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Depressive Disorder, Major</condition>
  <arm_group>
    <arm_group_label>Navigated TMS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each participant will receive 30 sessions of 10 Hz or 20 Hz navigated transcranial magnetic stimulation over the left DLPFC.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Navigated Transcranial Magnetic Stimulation</intervention_name>
    <description>This study is a feasibility trial. Each participant will receive 30sessions of 10 Hz or 20 Hz rTMS over the left DLPFC. The rTMS interventions will be guided by a neuronavigation system (StimGuide TMS Navigation System, Magstim, Ltd. Carmarthenshire, UK) for navigation to the treatment location and to ensure consistent placement and orientation of the coil during and between each session. For the purpose of this protocol, these sessions are referred to as nTMS.</description>
    <arm_group_label>Navigated TMS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of medication-resistant MDD,&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Normal findings in the medical history, physical, and neurological examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of seizure disorder&#xD;
&#xD;
          -  History of neuroleptic medications/prior use of neuroleptics&#xD;
&#xD;
          -  Presence of implanted medical pump, metal plate, or metal object in skull or eye&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lothar Krinke, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Magstim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Georgia Behavioral Health Professionals</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Behavioral Health Professionals</name>
      <address>
        <city>Dunwoody</city>
        <state>Georgia</state>
        <zip>30338</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>January 2, 2020</last_update_submitted>
  <last_update_submitted_qc>January 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Transcranial Magnetic Stimulation</keyword>
  <keyword>Navigated Transcranial Magnetic Stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT03795051/Prot_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03795051
org study id: MGS-2018-SS
nct id: NCT03795051
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The objective of this study is to evaluate the feasibility of adding a navigational system to
      traditional repetitive Transcranial Magnetic Stimulation (rTMS, referred to in this
      application as nTMS) as a way to establish and maintain precise coil positioning (contact,
      rotation, and tilt) and consistent brain region targeting throughout a nTMS treatment session
      and in subsequent nTMS sessions.
Objective: The objective of this study is to evaluate the feasibility of adding a
      navigational system to traditional repetitive Transcranial Magnetic Stimulation (rTMS,
      referred to in this application as nTMS) as a way to establish and maintain precise coil
      positioning (contact, rotation, and tilt) and consistent brain region targeting throughout a
      nTMS treatment session and in subsequent nTMS sessions. Success will be evaluated via data
      analysis of information captured during nTMS, which will evaluate coordinates, contact,
      rotation, and tilt parameters of the stimulation pulses delivered. The study will be
      conducted with patients who have been selected as traditional rTMS candidates and have met
      the criteria for rTMS, which includes, but is not limited to the following: Adults with Major
      Depressive Disorder (MDD) who have failed to achieve satisfactory improvement from prior
      antidepressant medication in the current episode. For the purposes of this study, nTMS is
      referring to the use of a navigation device in combination with delivery of traditional rTMS.

      Aim 1: Determine the percentage of successful nTMS treatment sessions. A successful nTMS
      treatment session is defined as the following: 80% of the TMS pulse trains are delivered
      while the coil is within acceptance criteria measured by tracking the following parameters:
      coil deviations from digitally saved target location, which includes contact (mm), rotation
      (°), and tilt (°) parameters. The acceptance criteria are met with coil position at the time
      of pulse delivery as follows: coil rotation within ±15° of target; coil tilt within ±15° of
      target; in-plane deviation within ±5mm of target; contact deviation within ±2mm of target.

      Aim 2: Determine Patient Health Questionnaire (PHQ-9) change measured weekly from baseline to
      after 30 sessions of nTMS, collect Patient comfort data, measure Operator confidence and
      collect coil position data for nTMS sessions to determine future product improvements and
      clinical studies.

      The goal of this proposal is to establish nTMS as a means of precise administration of
      transcranial magnetic stimulation. Ultimately, data from this study will be used to design
      larger, comparative studies to establish superior efficacy profiles in the treatment of MDD.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of successful nTMS treatment sessions
time frame: The number of successful treatment sessions will be assessed after 6 weeks of treatment. Only data from week 2 through 6 will be included (approximately 25 treatment sessions). (Example 20 out of 25 sessions were successful.)
description: The primary outcome measure will be the percentage of successful nTMS treatment sessions pooled from sessions 6 through 30 for each study subject. A successful nTMS treatment session is defined as: 80% of the TMS pulse trains are delivered while the coil is within acceptance criteria measured by tracking the following parameters: coil deviations from digitally saved target location, which includes contact (mm), rotation (°), and tilt (°) parameters. The acceptance criteria are met with coil position at the time of pulse delivery as follows: coil rotation within ±15° of target; coil tilt within ±15° of target; in-plane deviation within ±5mm of target; contact deviation within ±2mm of target.
measure: Operator Confidence
time frame: Aproximately 5 months after first patient treatment. After last study patient at site has completed the treatment or has exited the study (expected for May 2019).
description: Operator confidence will be measured on a scale of 1 to 5; 1 being not confident at all in using StimGuide to consistently find the treatment site and deliver therapy to 5 being very confident in using StimGuide to consistently find the treatment site and deliver therapy.
measure: Patient Comfort
time frame: After last treatment has been completed; approximately six week after treatment start
description: Patient comfort measured on a scale from 1 to 5; with 1 being uncomfortable and 5 being extremely comfortable
measure: Patient Health Questionnaire 9 (PHQ-9) - Patient Depression Questionnaire
time frame: At baseline and after six weeks of treatment
description: Patient Health Questionnaire (PHQ-9) change from baseline. The PHQ-9 Patient Depression Questionnaire has 9 questions with a scale range for each question of 0 to 3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day. The maximum summed score (severely depressed) is 27.
measure: Coil Position deviation from target
time frame: Coil position deviation: every treatment session during week 2 through 6
description: Coil deviation for every pulse train for each patient's nTMS session. Coil deviations from digitally saved target location, which includes contact (mm), rotation (°), and tilt (°) parameters will be measured and reported.
arm group label: Navigated TMS
arm group type: Experimental
description: Each participant will receive 30 sessions of 10 Hz or 20 Hz navigated transcranial magnetic stimulation over the left DLPFC.
intervention type: Device
intervention name: Navigated Transcranial Magnetic Stimulation
description: This study is a feasibility trial. Each participant will receive 30sessions of 10 Hz or 20 Hz rTMS over the left DLPFC. The rTMS interventions will be guided by a neuronavigation system (StimGuide TMS Navigation System, Magstim, Ltd. Carmarthenshire, UK) for navigation to the treatment location and to ensure consistent placement and orientation of the coil during and between each session. For the purpose of this protocol, these sessions are referred to as nTMS.
arm group label: Navigated TMS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Lothar Krinke, PhD
role: Principal Investigator
affiliation: Magstim
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major
provided document: 