<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/NCT03832777</url>
  </required_header>
  <id_info>
    <org_study_id>04-01/02/2018</org_study_id>
    <nct_id>NCT03832777</nct_id>
  </id_info>
  <brief_title>Transcranial Magnetic Stimulation on Dorsomedial Prefrontal Cortex in Borderline Personality Disorder</brief_title>
  <acronym>TMS&amp;BPD</acronym>
  <official_title>Effect of Transcranial Magnetic Stimulation on Dorsomedial Cortex in Clinical and Neuropsychological Variables in Borderline Personality Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Autonoma de Queretaro</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Autonoma de Queretaro</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effect of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) on&#xD;
      Dorsomedial Prefrontal Cortex on Borderline Personality Disorder (BPD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Borderline Personality Disorder (BPD) is a mental illness with a high worldwide prevalence&#xD;
      and economic costs, and is characterized with impulsiveness, both interpersonal relationships&#xD;
      and emotional disturbance. Symptoms are related to hypofunction of frontal areas like&#xD;
      Dorsomedial Prefrontal Cortex (DMPFC). Psychotherapy is the base treatment in this disease,&#xD;
      but economic costs and long-time therapy have made difficult the attachment. Repetitive&#xD;
      Transcranial Magnetic Stimulation(rTMS), authorized by Food and Drug Administration (FDA) on&#xD;
      Major Depressive Disorder (MDD) treatment has proven good results in previous works in BPD&#xD;
      clinical characteristics on both dorsolateral prefrontal cortex (DLPFC) and enhancement in&#xD;
      depressive symptoms stimulating DMPFC in high frequency. However, there are no current&#xD;
      research that have addressed the use of low-frequency on this anatomical area.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 5, 2018</start_date>
  <completion_date type="Anticipated">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 30, 2019</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>Crossover Assignment</intervention_model>
    <intervention_model_description>The aim of this study is to evaluate the clinical effects of 5Hz rTMS over Dorsomedial Prefrontal Cortex on an active versus placebo modality stimulation.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Single</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Borderline Symptoms List (BSL)</measure>
    <time_frame>6 weeks</time_frame>
    <description>BSL is a 23 item scale that evaluates the general symptoms and 11 items with behavioural evaluation of BPD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Global Clinical Impression of BPD (GCI-BPD)</measure>
    <time_frame>6 weeks</time_frame>
    <description>CGI-BPD is a 10 item evaluation that rates the severity of BPD distributed in 9 neuropsychological domains with a final global score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Borderline Evaluation of Severity Over Time (BEST)</measure>
    <time_frame>6 weeks</time_frame>
    <description>BEST is a 15 item scale that evaluates the severity in this pathology according to 3 areas: thoughts, emotions and typical behaviours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hamilton Depression Rating Scale (HDRS)</measure>
    <time_frame>6 weeks</time_frame>
    <description>HDRS is a 21 item scale that evaluates the severity of depressive symptoms in patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hamilton Anxiety Rating Scale (HARS)</measure>
    <time_frame>6 weeks</time_frame>
    <description>HARS is a 14 items rating scale that evaluates the severity of anxiety symptoms in patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barratt Impulsivity Scale (BIS-11)</measure>
    <time_frame>6 weeks</time_frame>
    <description>The Barratt Impulsiveness Scale is a questionnaire designed to assess the personality / behavioral construct of impulsiveness; composed of 30 items describing common impulsive or non-impulsive (for reversed scored items) behaviors and preferences .</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Borderline Personality Disorder</condition>
  <arm_group>
    <arm_group_label>5 Hz Stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive 5Hz (Hertz) Dorsomedial Prefrontal Cortex repetitive Transcranial Magnetic Stimulation with 1500 pulses per session, once per weekday, with a final result of 15 sessions in this modality.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Stimulation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This group will receive the Sham modality simulating 1500 pulses of 5Hz Transcranial Magnetic Stimulation for 15 sessions, one per weekday.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Repetitive Transcranial Magnetic Stimulation</intervention_name>
    <description>Subjects will receive both active and placebo rTMS, in a crossover modality.</description>
    <arm_group_label>5 Hz Stimulation</arm_group_label>
    <arm_group_label>Placebo Stimulation</arm_group_label>
    <other_name>Transcranial Magnetic Stimulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-45 years old.&#xD;
&#xD;
          -  Meet DSM 5 (Diagnostic and Statistical Manual, 5th edition) diagnostic criteria for&#xD;
             Borderline Personality Disorder.&#xD;
&#xD;
          -  Score of &gt;7 in the Diagnostic Interview for Borderline (Revised version, DIB-R)&#xD;
&#xD;
          -  All patients must have follow-up psychotherapy of at least one month.&#xD;
&#xD;
          -  No changes on pharmacological treatment within the last month.&#xD;
&#xD;
          -  Patients must provide their oral and written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with history of traumatic brain injury with loss of consciousness.&#xD;
&#xD;
          -  Subjects with intracranial metallic objects or metal plates in the skull.&#xD;
&#xD;
          -  Subjects diagnosed with uncontrolled chronic (for example: hypertension, diabetes) or&#xD;
             neurological diseases.&#xD;
&#xD;
          -  Comorbidity with other mental illness. (Except Depressive symptoms and Anxiety&#xD;
             Disorders).&#xD;
&#xD;
          -  Presence of psychotic symptoms.&#xD;
&#xD;
          -  Alterations in the electroencephalogram (epileptiform activity).&#xD;
&#xD;
          -  Self injury or suicidal attempts in less than 2 weeks (depends on the severity and&#xD;
             deepness).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julian V Reyes-López, Psychiatrist</last_name>
    <role>Study Director</role>
    <affiliation>Faculty of Medicine, Autonomous University of Queretaro</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Angel R Calderón-Moctezuma, Physician</last_name>
    <phone>+52 9511047213</phone>
    <email>angel_roman_cm@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Autonomous University of Queretaro</name>
      <address>
        <city>Querétaro City</city>
        <state>Querétaro</state>
        <zip>76176</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Angel R Calderón-Moctezuma, Physician</last_name>
      <phone>+529511047213</phone>
      <email>angel_roman_cm@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 12, 2019</last_update_submitted>
  <last_update_submitted_qc>February 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Autonoma de Queretaro</investigator_affiliation>
    <investigator_full_name>Dr. Julian Reyes López</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Borderline Personality Disorder</keyword>
  <keyword>Personality Disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Personality Disorders</mesh_term>
    <mesh_term>Borderline Personality Disorder</mesh_term>
  </condition_browse>
  <!-- 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/NCT03832777
org study id: 04-01/02/2018
nct id: NCT03832777
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effect of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) on
      Dorsomedial Prefrontal Cortex on Borderline Personality Disorder (BPD).
Borderline Personality Disorder (BPD) is a mental illness with a high worldwide prevalence
      and economic costs, and is characterized with impulsiveness, both interpersonal relationships
      and emotional disturbance. Symptoms are related to hypofunction of frontal areas like
      Dorsomedial Prefrontal Cortex (DMPFC). Psychotherapy is the base treatment in this disease,
      but economic costs and long-time therapy have made difficult the attachment. Repetitive
      Transcranial Magnetic Stimulation(rTMS), authorized by Food and Drug Administration (FDA) on
      Major Depressive Disorder (MDD) treatment has proven good results in previous works in BPD
      clinical characteristics on both dorsolateral prefrontal cortex (DLPFC) and enhancement in
      depressive symptoms stimulating DMPFC in high frequency. However, there are no current
      research that have addressed the use of low-frequency on this anatomical area.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: The aim of this study is to evaluate the clinical effects of 5Hz rTMS over Dorsomedial Prefrontal Cortex on an active versus placebo modality stimulation.
primary purpose: Treatment
masking: Single (Participant)
masking description: Single
measure: Borderline Symptoms List (BSL)
time frame: 6 weeks
description: BSL is a 23 item scale that evaluates the general symptoms and 11 items with behavioural evaluation of BPD.
measure: Global Clinical Impression of BPD (GCI-BPD)
time frame: 6 weeks
description: CGI-BPD is a 10 item evaluation that rates the severity of BPD distributed in 9 neuropsychological domains with a final global score.
measure: Borderline Evaluation of Severity Over Time (BEST)
time frame: 6 weeks
description: BEST is a 15 item scale that evaluates the severity in this pathology according to 3 areas: thoughts, emotions and typical behaviours.
measure: Hamilton Depression Rating Scale (HDRS)
time frame: 6 weeks
description: HDRS is a 21 item scale that evaluates the severity of depressive symptoms in patients.
measure: Hamilton Anxiety Rating Scale (HARS)
time frame: 6 weeks
description: HARS is a 14 items rating scale that evaluates the severity of anxiety symptoms in patients.
measure: Barratt Impulsivity Scale (BIS-11)
time frame: 6 weeks
description: The Barratt Impulsiveness Scale is a questionnaire designed to assess the personality / behavioral construct of impulsiveness; composed of 30 items describing common impulsive or non-impulsive (for reversed scored items) behaviors and preferences .
arm group label: 5 Hz Stimulation
arm group type: Active Comparator
description: This group will receive 5Hz (Hertz) Dorsomedial Prefrontal Cortex repetitive Transcranial Magnetic Stimulation with 1500 pulses per session, once per weekday, with a final result of 15 sessions in this modality.
arm group label: Placebo Stimulation
arm group type: Placebo Comparator
description: This group will receive the Sham modality simulating 1500 pulses of 5Hz Transcranial Magnetic Stimulation for 15 sessions, one per weekday.
intervention type: Device
intervention name: Repetitive Transcranial Magnetic Stimulation
description: Subjects will receive both active and placebo rTMS, in a crossover modality.
arm group label: 5 Hz Stimulation
arm group label: Placebo Stimulation
other name: Transcranial Magnetic Stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Julian V Reyes-López, Psychiatrist
role: Study Director
affiliation: Faculty of Medicine, Autonomous University of Queretaro
last name: Angel R Calderón-Moctezuma, Physician
phone: +52 9511047213
email: angel_roman_cm@hotmail.com
facility: 
status: Recruiting
contact: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Universidad Autonoma de Queretaro
investigator full name: Dr. Julian Reyes López
investigator title: Professor
mesh term: Personality Disorders
mesh term: Borderline Personality Disorder