<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/NCT01723319</url>
  </required_header>
  <id_info>
    <org_study_id>SH-0025-12</org_study_id>
    <nct_id>NCT01723319</nct_id>
  </id_info>
  <brief_title>A Double Blind Randomized Controlled Evaluation of the HBLPADD-coil Transcranial Magnetic Stimulation (TMS) Device - Efficacy and Safety In Subjects With ADHD.</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>
      Objectives:The purpose of the study is to explore the efficacy and safety of HBLPADD Coil&#xD;
      deep brain TMS in subjects with ADHD.&#xD;
&#xD;
      Patient Population: The intention is to treat 40 patients diagnosed with ADHD. The patients&#xD;
      will be of all racial, ethnic and gender categories, ranging from 18 to 65 years of age.&#xD;
&#xD;
      Structure: The study is a randomized, prospective, 5 weeks, double blind study. Blinding: The&#xD;
      treatment administrator and the study personnel and patients will be masked to the treatment&#xD;
      being administrated.&#xD;
&#xD;
      The study group will receive active dTMS treatment and the control group will receive an&#xD;
      inactive, sham treatment&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <primary_completion_date type="Anticipated">May 2013</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>Efficacy will be examined by the change in the CAARS questionnaire from the baseline visit to the determination visit in the treatment group compared to the control group.</measure>
    <time_frame>5 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical improvement as measured using Clinical global Impression (CGI).</measure>
    <time_frame>5 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>ADHD</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>deep TMS treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>inactive treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HBLPADD coil deep TMS</intervention_name>
    <description>20 daily deep TMS treatment</description>
    <arm_group_label>1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham</intervention_name>
    <description>inactive treatment</description>
    <arm_group_label>2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients between the ages of 18-65(male and female).&#xD;
&#xD;
          2. Diagnosed as suffering from Attention-Deficit Hyperactivity Disorder according to the&#xD;
             DSM IV.&#xD;
&#xD;
          3. Patients taking medication for ADHD will give their consent to stop those medication&#xD;
             48 before entering the study and throughout the daily treatments.&#xD;
&#xD;
          4. Gave informed consent for participation in the study.&#xD;
&#xD;
          5. If referred by the treating psychiatrist, he or she approves of the subjects&#xD;
             participation in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Suffering from other diagnosis on axis 1.&#xD;
&#xD;
          2. antipsychotic treatment with stabilizers; medications from the Benzodiazepines group&#xD;
             are allowed, if need be,to a maximum dosage of 2 mg lorazepam.&#xD;
&#xD;
          3. History of lack of tolerance to TMS.&#xD;
&#xD;
          4. Axis 2 diagnosis according to the DSM IV.&#xD;
&#xD;
          5. Substantial suicidal risk as judged by the treating psychiatrist or by an independent&#xD;
             psychiatrist.&#xD;
&#xD;
          6. Attempted suicide in the past year.&#xD;
&#xD;
          7. High and not controlled blood pressure.&#xD;
&#xD;
          8. History of epilepsy, seizure, or hot spasm.&#xD;
&#xD;
          9. History of epilepsy or seizure in first degree relatives.&#xD;
&#xD;
         10. History of a significant head injury&#xD;
&#xD;
         11. History of metal in the head (outside the mouth space).&#xD;
&#xD;
         12. 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;
         13. Use of hearing aids for hearing loss.&#xD;
&#xD;
         14. History of frequent or severe headaches.&#xD;
&#xD;
         15. History of drug or alcohol abuse during the last year.&#xD;
&#xD;
         16. Inability to achieve satisfying level of communication with the subject.&#xD;
&#xD;
         17. Participation in current clinical study or clinical study within 30 days prior to this&#xD;
             study&#xD;
&#xD;
         18. Patients declared as legally incompetent, with an appointed physical guardian and/or&#xD;
             cannot sign informed consent due to cognitive incompetence.&#xD;
&#xD;
         19. Women - Pregnancy or not using a reliable method of birth control.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>yechiel levkovitz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shalvata Mental Health Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yechiel Levkovitz, MD</last_name>
    <phone>972-9-7478644</phone>
    <email>ylevk@clalit.org.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shalvata</name>
      <address>
        <city>Hod hasharon</city>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Yechiel levkovitz, MD</last_name>
      <phone>972-9-7478644</phone>
      <email>ylevk@clalit.org.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>November 5, 2012</last_update_submitted>
  <last_update_submitted_qc>November 5, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 7, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ADHD</keyword>
  <keyword>TMS</keyword>
  <keyword>brain stimulation</keyword>
  <keyword>clinical improvement</keyword>
  <!-- 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/NCT01723319
org study id: SH-0025-12
nct id: NCT01723319
lead sponsor: 
has dmc: Yes
Objectives:The purpose of the study is to explore the efficacy and safety of HBLPADD Coil
      deep brain TMS in subjects with ADHD.

      Patient Population: The intention is to treat 40 patients diagnosed with ADHD. The patients
      will be of all racial, ethnic and gender categories, ranging from 18 to 65 years of age.

      Structure: The study is a randomized, prospective, 5 weeks, double blind study. Blinding: The
      treatment administrator and the study personnel and patients will be masked to the treatment
      being administrated.

      The study group will receive active dTMS treatment and the control group will receive an
      inactive, sham treatment
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Efficacy will be examined by the change in the CAARS questionnaire from the baseline visit to the determination visit in the treatment group compared to the control group.
time frame: 5 weeks
measure: clinical improvement as measured using Clinical global Impression (CGI).
time frame: 5 weeks
arm group label: 1
arm group type: Experimental
description: deep TMS treatment
arm group label: 2
arm group type: Sham Comparator
description: inactive treatment
intervention type: Device
intervention name: HBLPADD coil deep TMS
description: 20 daily deep TMS treatment
arm group label: 1
intervention type: Device
intervention name: Sham
description: inactive treatment
arm group label: 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: yechiel levkovitz, MD
role: Principal Investigator
affiliation: Shalvata Mental Health Center
last name: Yechiel Levkovitz, MD
phone: 972-9-7478644
email: ylevk@clalit.org.il
facility: 
contact: 
country: Israel
responsible party type: Sponsor