<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/NCT02206516</url>
  </required_header>
  <id_info>
    <org_study_id>0214-14</org_study_id>
    <nct_id>NCT02206516</nct_id>
  </id_info>
  <brief_title>Feasibility of Transcranial Direct Current Stimulation (tDCS) in the Treatment of Adult Attention Deficit Disorder (ADD).</brief_title>
  <acronym>BMST</acronym>
  <official_title>Using Combined Neuroimaging Techniques and Clinical Measures to Assess Feasibility of tDCS as an Intervention in Adult ADD.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ElMindA Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brainsway</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ornim Medical Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims at combining imaging techniques and clinical evaluations to assess clinical&#xD;
      change as well as brain changes that occur as a result of brain stimulation in adult&#xD;
      attention deficit disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will use clinical measures and cognitive tasks covering 3 different functional&#xD;
      domains during functional magnetic resonance imaging (fMRI), ElectroEncephaloGram (EEG) and&#xD;
      Ultrasound tagged near infrared spectroscopy (UT-NIRS), to assess functional brain changes as&#xD;
      a result of a treatment protocol with Transcaranial direct current stimulation (tDCS) in&#xD;
      adults suffering from attention deficit disorder (ADD).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <phase>Phase 1</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>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>6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in functional activity after 4 weeks of tDCS treatment during response inhibition</measure>
    <time_frame>6 weeks</time_frame>
    <description>ROI analysis of right Inferior frontal cortex will be measured during response inhibition in the Go/Nogo task at the end of the 4 weeks of treatment and will be compared to baseline measures.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Adult Attention Deficit Disorder</condition>
  <arm_group>
    <arm_group_label>patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stimulation using tDCS will be administered daily, 5 days a week for 4 weeks. each session will last 22 minutes during which the anode electrode will be positioned over the right Inferior Frontal Gyrus (IFG) and the Katode electrode over the right Orbito Frontal Gyrus (OFG).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial Direct Current Stimulation</intervention_name>
    <arm_group_label>patients</arm_group_label>
    <other_name>neuroConn GmbH, Germany</other_name>
  </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. History of drug or alcohol abuse during the last year&#xD;
&#xD;
          3. Inability to achieve satisfying level of communication with the subject&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Talma Hendler, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>TASMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>TASMC</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>March 7, 2018</last_update_submitted>
  <last_update_submitted_qc>March 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2018</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>Attention Deficit Disorder with Hyperactivity</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/NCT02206516
org study id: 0214-14
nct id: NCT02206516
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This study aims at combining imaging techniques and clinical evaluations to assess clinical
      change as well as brain changes that occur as a result of brain stimulation in adult
      attention deficit disorder.
This study will use clinical measures and cognitive tasks covering 3 different functional
      domains during functional magnetic resonance imaging (fMRI), ElectroEncephaloGram (EEG) and
      Ultrasound tagged near infrared spectroscopy (UT-NIRS), to assess functional brain changes as
      a result of a treatment protocol with Transcaranial direct current stimulation (tDCS) in
      adults suffering from attention deficit disorder (ADD).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
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: 6 weeks
measure: changes in functional activity after 4 weeks of tDCS treatment during response inhibition
time frame: 6 weeks
description: ROI analysis of right Inferior frontal cortex will be measured during response inhibition in the Go/Nogo task at the end of the 4 weeks of treatment and will be compared to baseline measures.
arm group label: patients
arm group type: Experimental
description: Stimulation using tDCS will be administered daily, 5 days a week for 4 weeks. each session will last 22 minutes during which the anode electrode will be positioned over the right Inferior Frontal Gyrus (IFG) and the Katode electrode over the right Orbito Frontal Gyrus (OFG).
intervention type: Device
intervention name: Transcranial Direct Current Stimulation
arm group label: patients
other name: neuroConn GmbH, Germany
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Talma Hendler, MD, PhD
role: Principal Investigator
affiliation: TASMC
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Attention Deficit Disorder with Hyperactivity