<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/NCT01683136</url>
  </required_header>
  <id_info>
    <org_study_id>SHA-09-11</org_study_id>
    <nct_id>NCT01683136</nct_id>
  </id_info>
  <brief_title>Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Feasibility Study for the Treatment of Borderline Personality Disorder</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shalvata Mental Health Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shalvata Mental Health Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open study.approximately 20 patients diagnosed with Borderline Personality&#xD;
      Disorder (in case patient is under drug treatment, treatment should be stable within the&#xD;
      prior 4 weeks before study entry).Starting from the third day, subjects would undergo rTMS&#xD;
      (repetitive Transcranial Magnetic Stimulation) for five days a week, for four weeks, and will&#xD;
      be clinically evaluated in order to monitor for improvement.&#xD;
&#xD;
      The investigators anticipate a significant reduction in symptoms severity at the end of the&#xD;
      treatment compared to study entry.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The symptoms of borderline personality disorder can be treated, but there is no known cure.&#xD;
&#xD;
      Several recent studies have shown that patients suffering from borderline personality&#xD;
      disorder (BPD) express a significant hypoactivity and smaller gray matter concentration in&#xD;
      the anterior cingulate cortex (ACC), compared to healthy controls.&#xD;
&#xD;
      In this current study we are attempting to find a better solution for the treatment of&#xD;
      Borderline Personality Disorder using deep Transcranial magnetic stimulation (dTMS)&#xD;
      technology.&#xD;
&#xD;
      The HBDL coil is intended to induce activation of prefrontal and orbitofrontal brain&#xD;
      structures, including the ACC, in order to induce long term potentiation in this brain&#xD;
      region.&#xD;
&#xD;
      The protocol includes bilateral stimulation to the SMA at 110% of the motor threshold of the&#xD;
      Abductor Policies Brevis and at a frequency of 10 Hz. each session is comprised of four&#xD;
      cycles of 3 seconds of stimulation and a 20 seconds recess(Total number of pulses:&#xD;
      1200).approximately 20 patients diagnosed with Borderline Personality Disorder will&#xD;
      participate. subjects would undergo rTMS sessions for five days a week, for four weeks, using&#xD;
      the HBDL dTMS coil. this coil is capable of producing a magnetic field in deeper parts of the&#xD;
      cerebral cortex, and for that reason we believe that it can produce better clinical outcomes&#xD;
      then superficial TMS coils used in earlier studies.&#xD;
&#xD;
      The goal of this study is to determine the safety and efficacy of transcranial magnetic&#xD;
      stimulation (TMS) in treating patients suffering from borderline personality disorder.&#xD;
&#xD;
      Our main objective is to observe a reduction in the severity of the symptoms post treatment&#xD;
      in comparison to pre treatment, using the zan-bpd as the main outcome measure. Additional&#xD;
      objective is to observe normalizaition of borderline's empathic tendencies: on one hand, we&#xD;
      expect their affective empathy to be compromised post treatment in comparison to pre&#xD;
      treatment. on the other hand, we expect heir cognitive empathy to be increased post treatment&#xD;
      in comparison to pre treatment.&#xD;
&#xD;
      Note that on the first day subjects will be randomized to receive sham stimulation or real&#xD;
      stimulation. subject who received real stimulation on the first day will receive sham&#xD;
      stimulation on the second day. Likewise, Subjects who received sham stimulation on the first&#xD;
      day will receive real stimulation on the second day. After receiving stimulation subjects&#xD;
      will perform a facemorph task which evaluates their empathic capabilities.&#xD;
&#xD;
      the 20 day of treatments will be started from the third day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <primary_completion_date type="Anticipated">March 2014</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>Change from Baseline in ZAN-BPD</measure>
    <time_frame>every 2 weeks, up to 4 weeks.</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Borderline Personality Disorder</condition>
  <arm_group>
    <arm_group_label>Deep TMS treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>inactive stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)</intervention_name>
    <description>on the first day subjects will be randomized to receive sham stimulation or real stimulation. subject who received real stimulation on the first day will receive sham stimulation on the second day. Likewise, Subjects who received sham stimulation on the first day will receive real stimulation on the second day. After receiving stimulation subjects will perform a facemorph task which evaluates their empathic capabilities.&#xD;
From the third treatment all subjects will recive a real stimulaitiobn: a session of rdTMS includes 4 cycles of 5 minutes of stimulation at a frequency of 10 Hz to the supplementary motor cortex and then a 20 seconds recess.each subject would undergo 5 sessions a week for 4 weeks</description>
    <arm_group_label>Deep TMS treatment</arm_group_label>
    <arm_group_label>inactive stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and woman between the ages of 18-60&#xD;
&#xD;
          -  Diagnosed as suffering from Borderline Personality Disorder according to the DSM IV,&#xD;
             as determined by a senior psychiatrist on the basis of the Structured Clinical&#xD;
             Interview for DSM-IV Axis I&#xD;
&#xD;
          -  pharmocological treatment stays constant for the duration of the study&#xD;
&#xD;
          -  Gave informed consent for participation in the study&#xD;
&#xD;
          -  Not pregnant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Electroconvulsive therapy (ECT) less than 9 months prior to screening.&#xD;
&#xD;
          -  suicide risk (assessed by the patient's doctor)&#xD;
&#xD;
          -  Suffer from active AXIS I disorder (according to the DSM IV)during the 3 months before&#xD;
             study entry(besides: eating disorder, phobia and somatoform disorder)&#xD;
&#xD;
          -  History of seizure or heat convulsion.&#xD;
&#xD;
          -  History of epilepsy or seizure in first degree relatives.&#xD;
&#xD;
          -  History of head injury.&#xD;
&#xD;
          -  History of any metal in the head (outside the mouth).&#xD;
&#xD;
          -  Known history of any metallic particles in the eye, implanted cardiac pacemaker or any&#xD;
             intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.&#xD;
&#xD;
          -  History of frequent or severe headaches.&#xD;
&#xD;
          -  History of migraine.&#xD;
&#xD;
          -  History of hearing loss.&#xD;
&#xD;
          -  Pregnancy or not using a reliable method of birth control.&#xD;
&#xD;
          -  Inadequate communication with the patient.&#xD;
&#xD;
          -  Under custodial care.&#xD;
&#xD;
          -  Participation in current clinical study or&#xD;
&#xD;
          -  A significant physical illness which is not balanced.&#xD;
&#xD;
          -  Cerebral Palsy, history of encephalitis or other structural brain damage.&#xD;
&#xD;
          -  Pseudotumor cerebri&#xD;
&#xD;
          -  neurological deficit&#xD;
&#xD;
          -  Patients using high dosage of antipsychotic medicine :&#xD;
&#xD;
        more than 7.5 mg Haldol, 10 mg Olanzapine, 4 mg Risperdal, 400 mg SEROQUEL, 120 mg Geodon,&#xD;
        100 mg Clopixol, 12 mg Perphenan.&#xD;
&#xD;
        Patients taking Clozapine will not be recruited to the present study In case of taking&#xD;
        other antipsychotic medicine besides those listed above, the principal investigator will&#xD;
        decide whether patients are eligible for recruitment .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hagai Harari, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shalvata Mental Health Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hilik Levkovitz, Prof.</last_name>
    <phone>972-9-7478568</phone>
    <email>ylevk@clalit.org.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hila Gvirts, MA</last_name>
    <phone>972-9-7478644</phone>
    <email>hilagv@clalit.org.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shalvata Mental Health Center</name>
      <address>
        <city>Hod Hasharon,</city>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Hillik Levkovitz, Prof</last_name>
      <phone>972-9-7478568</phone>
      <email>ylevk@clalit.org.il</email>
    </contact>
    <contact_backup>
      <last_name>Hagai Harari, MD</last_name>
      <phone>972-9-7478500</phone>
      <email>rreh@clalit.org.il</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 21, 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>
  <last_update_submitted>September 6, 2012</last_update_submitted>
  <last_update_submitted_qc>September 6, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT01683136
org study id: SHA-09-11
nct id: NCT01683136
lead sponsor: 
has dmc: Yes
This is an open study.approximately 20 patients diagnosed with Borderline Personality
      Disorder (in case patient is under drug treatment, treatment should be stable within the
      prior 4 weeks before study entry).Starting from the third day, subjects would undergo rTMS
      (repetitive Transcranial Magnetic Stimulation) for five days a week, for four weeks, and will
      be clinically evaluated in order to monitor for improvement.

      The investigators anticipate a significant reduction in symptoms severity at the end of the
      treatment compared to study entry.
The symptoms of borderline personality disorder can be treated, but there is no known cure.

      Several recent studies have shown that patients suffering from borderline personality
      disorder (BPD) express a significant hypoactivity and smaller gray matter concentration in
      the anterior cingulate cortex (ACC), compared to healthy controls.

      In this current study we are attempting to find a better solution for the treatment of
      Borderline Personality Disorder using deep Transcranial magnetic stimulation (dTMS)
      technology.

      The HBDL coil is intended to induce activation of prefrontal and orbitofrontal brain
      structures, including the ACC, in order to induce long term potentiation in this brain
      region.

      The protocol includes bilateral stimulation to the SMA at 110% of the motor threshold of the
      Abductor Policies Brevis and at a frequency of 10 Hz. each session is comprised of four
      cycles of 3 seconds of stimulation and a 20 seconds recess(Total number of pulses:
      1200).approximately 20 patients diagnosed with Borderline Personality Disorder will
      participate. subjects would undergo rTMS sessions for five days a week, for four weeks, using
      the HBDL dTMS coil. this coil is capable of producing a magnetic field in deeper parts of the
      cerebral cortex, and for that reason we believe that it can produce better clinical outcomes
      then superficial TMS coils used in earlier studies.

      The goal of this study is to determine the safety and efficacy of transcranial magnetic
      stimulation (TMS) in treating patients suffering from borderline personality disorder.

      Our main objective is to observe a reduction in the severity of the symptoms post treatment
      in comparison to pre treatment, using the zan-bpd as the main outcome measure. Additional
      objective is to observe normalizaition of borderline's empathic tendencies: on one hand, we
      expect their affective empathy to be compromised post treatment in comparison to pre
      treatment. on the other hand, we expect heir cognitive empathy to be increased post treatment
      in comparison to pre treatment.

      Note that on the first day subjects will be randomized to receive sham stimulation or real
      stimulation. subject who received real stimulation on the first day will receive sham
      stimulation on the second day. Likewise, Subjects who received sham stimulation on the first
      day will receive real stimulation on the second day. After receiving stimulation subjects
      will perform a facemorph task which evaluates their empathic capabilities.

      the 20 day of treatments will be started from the third day.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline in ZAN-BPD
time frame: every 2 weeks, up to 4 weeks.
arm group label: Deep TMS treatment
arm group type: Experimental
arm group label: inactive stimulation
arm group type: Sham Comparator
intervention type: Device
intervention name: HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)
description: on the first day subjects will be randomized to receive sham stimulation or real stimulation. subject who received real stimulation on the first day will receive sham stimulation on the second day. Likewise, Subjects who received sham stimulation on the first day will receive real stimulation on the second day. After receiving stimulation subjects will perform a facemorph task which evaluates their empathic capabilities.
From the third treatment all subjects will recive a real stimulaitiobn: a session of rdTMS includes 4 cycles of 5 minutes of stimulation at a frequency of 10 Hz to the supplementary motor cortex and then a 20 seconds recess.each subject would undergo 5 sessions a week for 4 weeks
arm group label: Deep TMS treatment
arm group label: inactive stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Hagai Harari, MD
role: Principal Investigator
affiliation: Shalvata Mental Health Center
last name: Hilik Levkovitz, Prof.
phone: 972-9-7478568
email: ylevk@clalit.org.il
last name: Hila Gvirts, MA
phone: 972-9-7478644
email: hilagv@clalit.org.il
facility: 
contact: 
contact backup: 
country: Israel
responsible party type: Sponsor
mesh term: Personality Disorders
mesh term: Borderline Personality Disorder