<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/NCT02229903</url>
  </required_header>
  <id_info>
    <org_study_id>CTP-OCD-01</org_study_id>
    <nct_id>NCT02229903</nct_id>
  </id_info>
  <brief_title>An Evaluation of the Safety and Efficacy of the dTMS Treatment for OCD</brief_title>
  <official_title>A Prospective Double Blind Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Deep Transcranial Magnetic Stimulation (dTMS) in Obsessive-Compulsive Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brainsway</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brainsway</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the safety and efficacy of the Deep TMS (DTMS)&#xD;
      treatment in subjects with OCD. The device technology is based on the application of deep&#xD;
      brain TMS by means of repetitive pulse trains at a predetermined frequency. The Brainsway&#xD;
      DTMS study is a randomized, 10 week, double blind, multi-center trial comparing active DTMS&#xD;
      treatment to sham treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The OCD study will compare one group of OCD subjects receiving DTMS treatment (HAC-coil) to a&#xD;
      second group of OCD subjects receiving sham treatment (sham coil). The treatment group will&#xD;
      receive 5 weeks of daily DTMS treatments followed by 4 treatments in week 6, for a total of&#xD;
      29 treatment sessions. The control group will receive the same treatments with a sham coil.&#xD;
      Subjects may continue to take SSRI medications (if prescribed) and any other antidepressant&#xD;
      medications will be tapered down prior to the first treatment. SSRI medications approved for&#xD;
      OCD include Fluoxetine (Prozac, Sarafem, Symbyax), Fluvoxamine (Luvox, Luvox CR), Paroxetine&#xD;
      (Paxil, Paxil CR, Pexeva) and Sertraline (Zoloft). Efficacy will be assessed using the&#xD;
      Yale-Brown Obsessive Compulsive Scale score (YBOCS), as well as other efficacy scales. Safety&#xD;
      will be assessed by monitoring of adverse events, vital signs, physical and neurological&#xD;
      examination and using certain safety questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Yale Brown Obsessive Compulsive Scale (YBOCS) score</measure>
    <time_frame>6 Weeks</time_frame>
    <description>The primary objective of the study is to compare the change in Yale Brown Obsessive Compulsive Scale (YBOCS) scores from baseline to the 6 week (post-randomization) visit, between the two treatments groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Yale Brown Obsessive Compulsive Scale (YBOCS), Sheehan Disability Scale (SDS), Clinical Global Impression - Severity Scale (CGI-S), Clinical Global Impression - Improvement Scale (CGI-I)</measure>
    <time_frame>6 Weeks and 10 weeks</time_frame>
    <description>The secondary effectiveness objectives of the study are:&#xD;
i. Change from baseline to 6 weeks in Yale Brown Obsessive Compulsive Scale (YBOCS) (and other assessment scale) scores, between treatment groups.&#xD;
ii. Response rate at 6 weeks in Yale Brown Obsessive Compulsive Scale (YBOCS) score from baseline, between treatment groups; iii.Partial Response rate at 6 weeks in Yale Brown Obsessive Compulsive Scale (YBOCS) score, between treatment groups; iv. Change from baseline to 10 weeks in above scales. v. Remission rates at 6 weeks between treatment groups.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of adverse events, changes in vitals signs, physical and neurological results, changes in suicide scale and changes in cognitive scales</measure>
    <time_frame>10 Weeks</time_frame>
    <description>Safety of the DTMS treatment as defined by maintained subject baseline, pre-treatment, physical and neurological examinations and lack of significant increase in suicide ideation measured by:&#xD;
Vital signs&#xD;
Physical and neurological examination&#xD;
Scale for Suicide Ideation&#xD;
Cognitive evaluation using the Mini-Mental State Exam (MMSE), Buschke Selective Reminding Test (BSRT) and Autobiographical Memory Interview - Short Form (AMI-S) scales&#xD;
Any other adverse events (AEs).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Obsessive Compulsive Disorder</condition>
  <arm_group>
    <arm_group_label>Active DTMS Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active DTMS Treatment constitutes the Deep Transcranial Magnetci Stimulation (DTMS) which is a new form of TMS which allows direct stimulation of deeper neruonal pathways than the standard TMS. The DTMS coil is designed to allow deeper brain stimulation without significant increase of electric fields included in superficial cortical regions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Treatment</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The Sham Treatment consists of an electrical field which cannot invoke any action potentials and if no action potentials are induced, then the electric field is insignificant and there is no treatment effect on the brain.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active DTMS Treatment</intervention_name>
    <description>H-coil Deep TMS 29 TMS treatments over 6 weeks.</description>
    <arm_group_label>Active DTMS Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Treatment</intervention_name>
    <description>29 treatments over 6 weeks.</description>
    <arm_group_label>Sham Treatment</arm_group_label>
    <other_name>Deep TMS Sham treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - • Outpatients&#xD;
&#xD;
          -  Men and women 22-68 years of age.&#xD;
&#xD;
          -  Subjects diagnosed as suffering from OCD according to the DSM-IV-TR.&#xD;
&#xD;
          -  Subjects with at least moderate OCD, rating a YBOCS score of &gt;20.&#xD;
&#xD;
          -  Subjects are maintained on SSRI medication at at least a therapeutic dosage for at&#xD;
             least 2 months prior to study entry and for the duration of the trial and/or subjects&#xD;
             are maintained on psychotherapeutic behavioral intervention therapy (subjects&#xD;
             undergoing CBT treatment must be in the maintenance stage (i.e., not during the&#xD;
             assessment or skills acquisition or training stages).&#xD;
&#xD;
          -  Subjects with negative responses on the Transcranial Magnetic Stimulation Safety&#xD;
             Screening questionnaire (TASS).&#xD;
&#xD;
          -  According to the treating physician the subject is compliant with taking medication,&#xD;
             if applicable.&#xD;
&#xD;
          -  Subject is capable and willing to provide informed consent.&#xD;
&#xD;
          -  Subject is able to adhere to the treatment schedule.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - • Subjects diagnosed according to the SCID I as suffering from any other Axis I diagnosis&#xD;
        as the primary diagnosis.&#xD;
&#xD;
          -  Subjects diagnosed according to the SCID II as suffering from severe Personality&#xD;
             Disorder (excluding Obsessive Compulsive Personality Disorder) or hospitalized due to&#xD;
             exacerbation related to borderline personality disorder.&#xD;
&#xD;
          -  Present suicidal risk as assessed by the investigator using the Scale for Suicide&#xD;
             Ideation (SSI), brief mental status exam and psychiatric interview or significant&#xD;
             suicide risk based on HDRS-21 item 3 score of 3 or 4 or a history of attempted suicide&#xD;
             in the past year.&#xD;
&#xD;
          -  Subject has a history of epilepsy or seizure (EXCEPT those therapeutically induced by&#xD;
             ECT) or history of such in first degree relatives.&#xD;
&#xD;
          -  Subject has an increased risk of seizure for any reason, including prior diagnosis of&#xD;
             increased intracranial pressure, or history of significant head trauma with loss of&#xD;
             consciousness for greater than or equal to 5 minutes.&#xD;
&#xD;
          -  Subject has a history of head injury necessitating cranial surgery or prolonged coma.&#xD;
&#xD;
          -  Subject has a history of any metal in the head including the eyes and ears (outside&#xD;
             the mouth).&#xD;
&#xD;
          -  Subject has known history of any metallic particles in the eye, implanted cardiac&#xD;
             pacemaker or any intracardiac lines, implanted neurostimulators, intracranial implant&#xD;
             (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or&#xD;
             implanted medical pumps.&#xD;
&#xD;
          -  Subject has a history of significant hearing loss.&#xD;
&#xD;
          -  Subjects with significant neurological disorder or insult including, but not limited&#xD;
             to:&#xD;
&#xD;
          -  Any condition likely to be associated with increased intracranial pressure&#xD;
&#xD;
          -  Subject has a history of substance abuse including alcoholism within the past 6 months&#xD;
             (except nicotine and caffeine).&#xD;
&#xD;
          -  Inadequate communication with the patient.&#xD;
&#xD;
          -  Subject is currently participating in another clinical study or enrolled in another&#xD;
             clinical study within 30 days prior to this study.&#xD;
&#xD;
          -  Subjects who suffer from an unstable physical, systemic and metabolic disorder such as&#xD;
             unstabilized blood pressure or acute, unstable cardiac disease.&#xD;
&#xD;
          -  Subject is currently on any antidepressant medication other than SSRIs.&#xD;
&#xD;
          -  Subject is currently on Clomipramine&#xD;
&#xD;
          -  Subject has had previous treatment with TMS&#xD;
&#xD;
          -  Women who are breast-feeding&#xD;
&#xD;
          -  Women who are pregnant or with suspected pregnancy&#xD;
&#xD;
          -  Women of childbearing potential and not using a medically accepted form of&#xD;
             contraception when engaging in sexual intercourse.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>68 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph Zohar, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tel Hashomer Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Abraham Zangen, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Soroka University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California (UCLA)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida College of Medicine</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Mental Health Care Inc. - Juno Beach</name>
      <address>
        <city>Juno Beach</city>
        <state>Florida</state>
        <zip>33408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Mental Health Care Inc. - Royal Palm Beach</name>
      <address>
        <city>Royal Palm Beach</city>
        <state>Florida</state>
        <zip>33411</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuropharmacology Services</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TMS Hope Center of Long Island</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>11777</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lindner Center of HOPE, University of Cincinnati College of Medicine</name>
      <address>
        <city>Mason</city>
        <state>Ohio</state>
        <zip>45040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Addiction and Mental Health (CAMH)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Hashomer Hospital</name>
      <address>
        <city>Tel Hashomer</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Israel</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Germany</country>
  </removed_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>OCD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obsessive-Compulsive 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/NCT02229903
org study id: CTP-OCD-01
nct id: NCT02229903
lead sponsor: 
has dmc: Yes
The purpose of the study is to evaluate the safety and efficacy of the Deep TMS (DTMS)
      treatment in subjects with OCD. The device technology is based on the application of deep
      brain TMS by means of repetitive pulse trains at a predetermined frequency. The Brainsway
      DTMS study is a randomized, 10 week, double blind, multi-center trial comparing active DTMS
      treatment to sham treatment.
The OCD study will compare one group of OCD subjects receiving DTMS treatment (HAC-coil) to a
      second group of OCD subjects receiving sham treatment (sham coil). The treatment group will
      receive 5 weeks of daily DTMS treatments followed by 4 treatments in week 6, for a total of
      29 treatment sessions. The control group will receive the same treatments with a sham coil.
      Subjects may continue to take SSRI medications (if prescribed) and any other antidepressant
      medications will be tapered down prior to the first treatment. SSRI medications approved for
      OCD include Fluoxetine (Prozac, Sarafem, Symbyax), Fluvoxamine (Luvox, Luvox CR), Paroxetine
      (Paxil, Paxil CR, Pexeva) and Sertraline (Zoloft). Efficacy will be assessed using the
      Yale-Brown Obsessive Compulsive Scale score (YBOCS), as well as other efficacy scales. Safety
      will be assessed by monitoring of adverse events, vital signs, physical and neurological
      examination and using certain safety questionnaires.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Yale Brown Obsessive Compulsive Scale (YBOCS) score
time frame: 6 Weeks
description: The primary objective of the study is to compare the change in Yale Brown Obsessive Compulsive Scale (YBOCS) scores from baseline to the 6 week (post-randomization) visit, between the two treatments groups.
measure: Yale Brown Obsessive Compulsive Scale (YBOCS), Sheehan Disability Scale (SDS), Clinical Global Impression - Severity Scale (CGI-S), Clinical Global Impression - Improvement Scale (CGI-I)
time frame: 6 Weeks and 10 weeks
description: The secondary effectiveness objectives of the study are:
i. Change from baseline to 6 weeks in Yale Brown Obsessive Compulsive Scale (YBOCS) (and other assessment scale) scores, between treatment groups.
ii. Response rate at 6 weeks in Yale Brown Obsessive Compulsive Scale (YBOCS) score from baseline, between treatment groups; iii.Partial Response rate at 6 weeks in Yale Brown Obsessive Compulsive Scale (YBOCS) score, between treatment groups; iv. Change from baseline to 10 weeks in above scales. v. Remission rates at 6 weeks between treatment groups.
measure: Number of adverse events, changes in vitals signs, physical and neurological results, changes in suicide scale and changes in cognitive scales
time frame: 10 Weeks
description: Safety of the DTMS treatment as defined by maintained subject baseline, pre-treatment, physical and neurological examinations and lack of significant increase in suicide ideation measured by:
Vital signs
Physical and neurological examination
Scale for Suicide Ideation
Cognitive evaluation using the Mini-Mental State Exam (MMSE), Buschke Selective Reminding Test (BSRT) and Autobiographical Memory Interview - Short Form (AMI-S) scales
Any other adverse events (AEs).
arm group label: Active DTMS Treatment
arm group type: Active Comparator
description: Active DTMS Treatment constitutes the Deep Transcranial Magnetci Stimulation (DTMS) which is a new form of TMS which allows direct stimulation of deeper neruonal pathways than the standard TMS. The DTMS coil is designed to allow deeper brain stimulation without significant increase of electric fields included in superficial cortical regions.
arm group label: Sham Treatment
arm group type: Sham Comparator
description: The Sham Treatment consists of an electrical field which cannot invoke any action potentials and if no action potentials are induced, then the electric field is insignificant and there is no treatment effect on the brain.
intervention type: Device
intervention name: Active DTMS Treatment
description: H-coil Deep TMS 29 TMS treatments over 6 weeks.
arm group label: Active DTMS Treatment
intervention type: Device
intervention name: Sham Treatment
description: 29 treatments over 6 weeks.
arm group label: Sham Treatment
other name: Deep TMS Sham treatment
criteria: 
gender: All
minimum age: 22 Years
maximum age: 68 Years
healthy volunteers: No
last name: Joseph Zohar, Prof
role: Principal Investigator
affiliation: Tel Hashomer Hospital
last name: Abraham Zangen, Prof
role: Principal Investigator
affiliation: Soroka University Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: Israel
country: United States
country: Germany
responsible party type: Sponsor
mesh term: Obsessive-Compulsive Disorder