xml: <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/NCT06030024</url>
    </required_header>
    <id_info>
      <org_study_id>Attention</org_study_id>
      <nct_id>NCT06030024</nct_id>
    </id_info>
    <brief_title>Efficacy of Repetitive Transcranial Magnetic Stimulation in Adult Attention Deficit Disorder</brief_title>
    <official_title>An Open-lable Investigation of the Effect of rTMS on Attention in an Adult Sample Suffering From ADD</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Tehran</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Tehran</source>
    <oversight_info>
      <has_dmc>No</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>
        The purpose of the current open-lable study was to use low-frequency repetitive transcranial&#xD;
        magnetic stimulation (rTMS) to improve the attention deficits in a sample of adult patients&#xD;
        suffering from attention deficit disorder. Participants received 10 sessions of rTMS over Fz&#xD;
        (located using the EEG 10-20 international system) and underwent assessments of their&#xD;
        attentional capacity using the gradCPT task in an fMRI scanner, before and after the&#xD;
        intervention. Other behavioral assessments of their attention symptoms have also been&#xD;
        conducted.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 1, 2021</start_date>
    <completion_date type="Actual">March 1, 2023</completion_date>
    <primary_completion_date type="Actual">February 1, 2023</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 in performance</measure>
      <time_frame>Up to 10 days, i.e., before and after the completion of the 10 sessions of rTMS</time_frame>
      <description>Shortened version (4 min) of the continuous go/no-go task: gradual-onset continuous performance task (gradCPT)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in self-report attention scores</measure>
      <time_frame>Baseline, after 5 days of stimulation, after 10 days of stimulation; Range= 0-6; Higher scores represent worse outcome</time_frame>
      <description>The 6-item ASRS-V1.1 Adult ADHD Self-Report</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in investigator-rated attention scores</measure>
      <time_frame>Baseline, after 5 days of stimulation, after 10 days of stimulation; Range:0 - 54; Higher scores represent worse outcome</time_frame>
      <description>Investigator-Rated Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV (I-ADHD RS-IV) with adult prompts</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">10</enrollment>
    <condition>Attention Deficit Disorder</condition>
    <condition>ADHD</condition>
    <arm_group>
      <arm_group_label>Active rTMS</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in this one and only arm in the current study received active repetitive transcranial magnetic stimulation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>repetitive Transcranial Magnetic Stimulation</intervention_name>
      <description>Magnetic pulses delivered to the Fz area of the brain in a low frequency (1 Hz) manner.</description>
      <arm_group_label>Active rTMS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Normal intelligence level (&gt;90)&#xD;
  &#xD;
            -  Diagnosis of ADD by a psychiatrist using the ADHD-RS-IV with Adult Prompts&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Scores of 21 or more on BDI and/or BAI&#xD;
  &#xD;
            -  History of head trauma&#xD;
  &#xD;
            -  History of a major psychological or neurological condition&#xD;
  &#xD;
            -  Presence of metal in the head&#xD;
  &#xD;
            -  History of seizures&#xD;
  &#xD;
            -  Serious cardiovascular disease&#xD;
  &#xD;
            -  Use of medications with an impact on cognitive functions during the treatment window&#xD;
               (patients with a constant and stable dose were included)&#xD;
  &#xD;
            -  Recent use of alcohol or substance abuse&#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>Reza Rostami, M.D</last_name>
      <role>Study Director</role>
      <affiliation>University of Tehran</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Fatemeh Soltani, MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Tehran</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>National Brain Mapping Lab</name>
        <address>
          <city>Tehran</city>
          <zip>1439957131</zip>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Iran, Islamic Republic of</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Tehran</investigator_affiliation>
      <investigator_full_name>reza kazemi</investigator_full_name>
      <investigator_title>Assistant professor</investigator_title>
    </responsible_party>
    <keyword>rTMS</keyword>
    <keyword>ADHD</keyword>
    <keyword>ADD</keyword>
    <keyword>fMRI</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06030024
  org study id: Attention
  nct id: NCT06030024
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of the current open-lable study was to use low-frequency repetitive transcranial
        magnetic stimulation (rTMS) to improve the attention deficits in a sample of adult patients
        suffering from attention deficit disorder. Participants received 10 sessions of rTMS over Fz
        (located using the EEG 10-20 international system) and underwent assessments of their
        attentional capacity using the gradCPT task in an fMRI scanner, before and after the
        intervention. Other behavioral assessments of their attention symptoms have also been
        conducted.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in performance
  time frame: Up to 10 days, i.e., before and after the completion of the 10 sessions of rTMS
  description: Shortened version (4 min) of the continuous go/no-go task: gradual-onset continuous performance task (gradCPT)
  measure: Change in self-report attention scores
  time frame: Baseline, after 5 days of stimulation, after 10 days of stimulation; Range= 0-6; Higher scores represent worse outcome
  description: The 6-item ASRS-V1.1 Adult ADHD Self-Report
  measure: Change in investigator-rated attention scores
  time frame: Baseline, after 5 days of stimulation, after 10 days of stimulation; Range:0 - 54; Higher scores represent worse outcome
  description: Investigator-Rated Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV (I-ADHD RS-IV) with adult prompts
  arm group label: Active rTMS
  arm group type: Experimental
  description: Participants in this one and only arm in the current study received active repetitive transcranial magnetic stimulation.
  intervention type: Device
  intervention name: repetitive Transcranial Magnetic Stimulation
  description: Magnetic pulses delivered to the Fz area of the brain in a low frequency (1 Hz) manner.
  arm group label: Active rTMS
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Reza Rostami, M.D
  role: Study Director
  affiliation: University of Tehran
  last name: Fatemeh Soltani, MSc
  role: Principal Investigator
  affiliation: University of Tehran
  facility: 
  country: Iran, Islamic Republic of
  responsible party type: Principal Investigator
  investigator affiliation: University of Tehran
  investigator full name: reza kazemi
  investigator title: Assistant professor
  mesh term: Attention Deficit Disorder with Hyperactivity
  sharing ipd: No