<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/NCT04446442</url>
  </required_header>
  <id_info>
    <org_study_id>UTSW 022017-071</org_study_id>
    <nct_id>NCT04446442</nct_id>
  </id_info>
  <brief_title>Cerebellar tDCS in Children With Autism Spectrum Disorder</brief_title>
  <official_title>Biologic Effects and Efficacy of Cerebellar tDCS in Children With Autism Spectrum Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to investigate whether tDCS to the cerebellum&#xD;
      (specifically, the right crus I/II area of the cerebellum) of children and young adults with&#xD;
      autism spectrum disorders (ASD) is safe and to examine its effects on some of the symptoms of&#xD;
      ASD, such as repetitive behaviors and hyperactivity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be randomized, double-blind, and controlled. It will involve a group of 60&#xD;
      children with ASD (diagnosed with the Autism Diagnostic Observation Schedule (ADOS-2) by a&#xD;
      research-reliable clinician) coming in for an orientation day, where participants will be&#xD;
      acclimated to the testing environment, as well as undergo safety screening, and a mock MRI.&#xD;
      The investigators will recruit from a sample of children diagnosed with ASD (The diagnosis&#xD;
      must be made by experienced, research reliable clinicians using gold standard measures&#xD;
      including the Autism Diagnostic Observation schedule Second Edition Study, or ADOS-2 and a&#xD;
      diagnostic and developmental parent interview). The investigators will request this&#xD;
      information from the institution where the diagnosis was given with parent/caregiver&#xD;
      permission. Diagnostic information will be reviewed by the study neuropsychologist, and if&#xD;
      additional testing is needed to update or confirm the diagnosis, the investigators will&#xD;
      administer an ADOS-2 here at UTSW prior to other baseline measures. If diagnostic information&#xD;
      from a previous CADD clinic visit or an outside institution by a research reliable clinician&#xD;
      is current, the investigators will accept it.&#xD;
&#xD;
      Participants will complete in a variety of tasks during a pre-treatment visit. In addition,&#xD;
      baseline behavioral measurements will be performed. These tests include an abbreviated&#xD;
      measure of cognitive ability using the Stanford Binet-Fifth Edition, interpretation of facial&#xD;
      expressions, memory for faces, reading the mind in the eyes, triangle animations, cyberball&#xD;
      /social ball throwing, dimensional card change sort, and caregiver-completed behavioral scale&#xD;
      including the Autsim Spectrum Rating Scale (ASRS). Participants will also be asked about&#xD;
      their mood before, during, and after treatment. Participants will then be randomly assigned&#xD;
      into either a sham treatment group or an active treatment group. The next time the&#xD;
      participants come in, participants vitals will be monitored in addition to eye monitoring and&#xD;
      will undergo either 1 mA for 20 minutes of anodal or cathodal tDCS administration to Right&#xD;
      Crus I/II area of the cerebellum or sham treatment. Participants will undergo fMRI imaging&#xD;
      prior, during, and after anodal or cathodal tDCS. After the scans, testing will be repeated&#xD;
      and include interpretation of facial expression, memory for faces, reading the mind in the&#xD;
      eyes, triangle animations, theory of mind, cyberball/social ball throwing, and dimensional&#xD;
      card change sort. At the end of the visit parents/guardians/participants will receive a&#xD;
      safety questionnaire asking about the presence and severity of the possible side effects. The&#xD;
      participants will then follow up in 1 week with the safety questionnaire and at 1 month with&#xD;
      the safety questionnaire and the Autism Spectrum Rating Scale.&#xD;
&#xD;
      Study Procedures:&#xD;
&#xD;
      Investigators, including those involved in questionnaire and behavioral scales administration&#xD;
      and fMRI scanning/interpreting will be blinded to which treatment group participants are in.&#xD;
      Staff members in charge of applying tDCS will be aware of what treatment group the&#xD;
      participant is in but will not be involved in analysis of data to ensure blinding of results.&#xD;
      As far as the tDCS procedure goes, the device consists of a programmable current source with&#xD;
      a rechargeable battery with two wires connected to electrodes in fabric pads. The device&#xD;
      cannot be plugged into an outlet while the electrodes are connected, ensuring safety. tDCS&#xD;
      pads are moistened with 0.9% normal saline and placed on the participant's scalp using&#xD;
      elastic bands. During stimulation, the electrodes will apply 1 mA of constant DC electrical&#xD;
      current. Current will be increased over 10-60 seconds. The current will be applied for no&#xD;
      more than 20 minutes, after which the current is decreased over 10-60 seconds. In sham tDCS,&#xD;
      the current is increased and then immediately decreased to provide sensations associated with&#xD;
      tDCS (mild tingling or itching, which blinds the participant).&#xD;
&#xD;
      Testing will take place before (on orientation day) and after tDCS. Baseline testing includes&#xD;
      an ADOS-2 if deemed necessary, an abbreviated cognitive measure, interpretation of facial&#xD;
      expressions, memory for faces, reading the mind in the eyes, triangle animations, cyberball&#xD;
      /social ball throwing, dimensional card change sort, and caregiver-completed behavioral scale&#xD;
      including the Autsim Spectrum Rating Scale.. Testing immediately after tDCS includes only the&#xD;
      following: interpretation of facial expressions, memory for faces, reading the mind in the&#xD;
      eyes, triangle animations, theory of mind, cyberball/social ball throwing, and dimensional&#xD;
      card change sort.&#xD;
&#xD;
      Participants with ASD will come in on designated orientation days and be assigned an&#xD;
      alphanumeric identifier to ensure confidentiality. An initial safety screening will be done&#xD;
      to ensure no exclusion criteria are met. Participants will then be randomly split into either&#xD;
      a sham group or a treatment group. Baseline testing will be completed. Participants will then&#xD;
      be allowed to explore and become acclimated with study equipment, and a mock MRI will be done&#xD;
      on the first visit at the UTSW Advanced Imaging Research Center (AIRC).&#xD;
&#xD;
      Participants will be desensitized to the sounds and tactile sensations of the fMRI&#xD;
      environment while in a space similar to that of the scanner bore. Participants will practice&#xD;
      remaining still within the mock MRI while viewing a movie, and biofeedback is used to train&#xD;
      participants to keep their movement &lt;1mm during practice periods of 10 minutes. Participants&#xD;
      should be able to complete all of the screening in one visit. If participants cannot due to&#xD;
      time constraints participants will be brought back in on a different day to complete the&#xD;
      screening visit.&#xD;
&#xD;
      The next time participants return, participants will be hooked up to vitals and eye movement&#xD;
      monitoring and will be placed in the fMRI machine so the &quot;before&quot; scanning can begin. After&#xD;
      this &quot;before&quot; scan, tDCS electrodes will be applied and participants will again be placed in&#xD;
      the fMRI machine for the &quot;during&quot; scan. As soon as scanning begins, tDCS (either sham or&#xD;
      treatment of 1 mA for 20 minutes of anodal tDCS administration to the Right Crus I/II area of&#xD;
      the cerebellum) will begin as well. During tDCS treatment caregivers will receive a safety&#xD;
      questionnaire for them to assess any side effects occurring in their child. After this scan,&#xD;
      the tDCS electrode will be removed, and a final &quot;after&quot; fMRI scan will take place. The safety&#xD;
      questionnaire will be given after tDCS at the end of the visit and behavioral tests are&#xD;
      complete.The time estimated for all of this is about 90-180 minutes.&#xD;
&#xD;
      The Safety Questionnaire will be assessed again with follow-up visits 1 week and 1 month&#xD;
      afterwards using the same caregiver-completed scales.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 4, 2019</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of tDCS associated side effects assessed by tDCS Safety Assessment</measure>
    <time_frame>Post-Intervention up to one month</time_frame>
    <description>Observe whether tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) is safe and easily tolerated using a tDCS Safety Assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Autism Spectrum Disorder Symptoms assessed by NEPSY-2 Subtests</measure>
    <time_frame>Pre-Intervention at 1 week and Post-Intervention at 1 hour</time_frame>
    <description>Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, related to social behavior and cognition. The NEPSY-2 subtests include: Memory for Faces, Theory of Mind, and Affect Recognition. The NEPSY-2 subtests are designed to assess abilities related to memory, learning, and social perception.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Autism Spectrum Disorder Symptoms assessed by Reading the Mind in the Eyes</measure>
    <time_frame>Pre-Intervention at 1 week and Post-Intervention at 1 hour</time_frame>
    <description>Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, related to social behavior and cognition. This will be assessed by Reading the Mind in the Eyes, a measure of complex mental state recognition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Autism Spectrum Disorder Symptoms assessed by Triangle Animations/Social Perception Task</measure>
    <time_frame>Pre-Intervention at 1 week and Post-Intervention at 1 hour</time_frame>
    <description>Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, related to social behavior and cognition. The Triangle Animations/ Social Perception Task assesses Theory of Mind mental functions such as belief and intention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Autism Spectrum Disorder Symptoms assessed by Cyberball/Social Ball Throwing Task</measure>
    <time_frame>Pre-Intervention at 1 week and Post-Intervention at 1 hour</time_frame>
    <description>Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, related to social behavior. The Cyberball/Social Ball Throwing Task assesses engagement in social interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Autism Spectrum Disorder Symptoms assessed by Dimensional Change Card Sort</measure>
    <time_frame>Pre-Intervention at 1 week and Post-Intervention at 1 hour</time_frame>
    <description>Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, related to cognition. The Dimensional Change Card Sort is a measure of cognitive flexibility, also known as task switching or set shifting.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Autism Spectrum Disorder Symptoms assessed by Autism Spectrum Rating Scale</measure>
    <time_frame>Pre-Intervention at 1 week and Post-Intervention at 1 week and 1 month</time_frame>
    <description>Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, such as repetitive behaviors and hyperactivity. The Autism Spectrum Rating Scale (ASRS) is a nationally-standardized, norm-referenced checklist designed to identify symptoms, behaviors, and associated features of Autism Spectrum Disorders in children and adolescents. Using a five-point Likert rating scale (1- Never, 2- Rarely, 3- Occasionally, 4- Frequently, 5- Very Frequently), parents/caregivers are asked to evaluate how often they observed specific behaviors in the child or adolescent in areas such as socialization, communication, unusual behaviors, behavioral rigidity, sensory sensitivity, and self-regulation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Full Administration of Transcranial Direct Current Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject will undergo psychosocial and behavioral assessments at a session prior to the administration of tDCS. The second session will include the tDCS Administration; a current of 1 mA will be administered over 20 minutes to the right crusI/II area of the cerebellum with a 15 second fade in period at the beginning and a 15 second fade out period at the end. During the tDCS administration, subjects will undergo functional MRI scanning. After the tDCS administration, subjects will repeat psychosocial and behavioral assessments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Administration of Transcranial Direct Current Stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Each subject will undergo psychosocial and behavioral assessments at a session prior to the administration of tDCS. The second session will include the tDCS Administration; a current of 1mA increased over 15 seconds and immediately decreased over 15 seconds to provide sensation associated with tDCS. During the sham administration, subjects will undergo functional MRI scanning. After the tDCS administration, subjects will repeat psychosocial and behavioral assessments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS</intervention_name>
    <description>A current of 1 mA will be administered for 20 minutes of with either anodal or cathodal tDCS administration to the right crus I/II area of the cerebellum.</description>
    <arm_group_label>Full Administration of Transcranial Direct Current Stimulation</arm_group_label>
    <arm_group_label>Sham Administration of Transcranial Direct Current Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  4-17 years old&#xD;
&#xD;
          -  Diagnosed with ASD and ADOS-2&#xD;
&#xD;
          -  IQ Score no less than 70 (1.5 Standard Deviations below the mean)&#xD;
&#xD;
          -  Language Level (Speech consists of, at minimum, flexible, spontaneous, simple,&#xD;
             sentences)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Brain implants, metal implants, pacemakers, or biomedical devices&#xD;
&#xD;
          -  Diagnosis of epilepsy&#xD;
&#xD;
          -  Hearing or visual impairments&#xD;
&#xD;
          -  History of brain injury&#xD;
&#xD;
          -  Known brain abnormalities not associated with ASD&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Tsai, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Southwestern Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peter Tsai, MD, PhD</last_name>
    <phone>214-648-3577</phone>
    <email>peter.tsai@utsouthwestern.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amy Magallanes</last_name>
    <phone>214-648-5155</phone>
    <email>amy.magallanes@utsouthwestern.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Children's Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>November 12, 2019</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>December 21, 2022</last_update_submitted>
  <last_update_submitted_qc>December 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Peter Tsai</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04446442
org study id: UTSW 022017-071
nct id: NCT04446442
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this research study is to investigate whether tDCS to the cerebellum
      (specifically, the right crus I/II area of the cerebellum) of children and young adults with
      autism spectrum disorders (ASD) is safe and to examine its effects on some of the symptoms of
      ASD, such as repetitive behaviors and hyperactivity.
The study will be randomized, double-blind, and controlled. It will involve a group of 60
      children with ASD (diagnosed with the Autism Diagnostic Observation Schedule (ADOS-2) by a
      research-reliable clinician) coming in for an orientation day, where participants will be
      acclimated to the testing environment, as well as undergo safety screening, and a mock MRI.
      The investigators will recruit from a sample of children diagnosed with ASD (The diagnosis
      must be made by experienced, research reliable clinicians using gold standard measures
      including the Autism Diagnostic Observation schedule Second Edition Study, or ADOS-2 and a
      diagnostic and developmental parent interview). The investigators will request this
      information from the institution where the diagnosis was given with parent/caregiver
      permission. Diagnostic information will be reviewed by the study neuropsychologist, and if
      additional testing is needed to update or confirm the diagnosis, the investigators will
      administer an ADOS-2 here at UTSW prior to other baseline measures. If diagnostic information
      from a previous CADD clinic visit or an outside institution by a research reliable clinician
      is current, the investigators will accept it.

      Participants will complete in a variety of tasks during a pre-treatment visit. In addition,
      baseline behavioral measurements will be performed. These tests include an abbreviated
      measure of cognitive ability using the Stanford Binet-Fifth Edition, interpretation of facial
      expressions, memory for faces, reading the mind in the eyes, triangle animations, cyberball
      /social ball throwing, dimensional card change sort, and caregiver-completed behavioral scale
      including the Autsim Spectrum Rating Scale (ASRS). Participants will also be asked about
      their mood before, during, and after treatment. Participants will then be randomly assigned
      into either a sham treatment group or an active treatment group. The next time the
      participants come in, participants vitals will be monitored in addition to eye monitoring and
      will undergo either 1 mA for 20 minutes of anodal or cathodal tDCS administration to Right
      Crus I/II area of the cerebellum or sham treatment. Participants will undergo fMRI imaging
      prior, during, and after anodal or cathodal tDCS. After the scans, testing will be repeated
      and include interpretation of facial expression, memory for faces, reading the mind in the
      eyes, triangle animations, theory of mind, cyberball/social ball throwing, and dimensional
      card change sort. At the end of the visit parents/guardians/participants will receive a
      safety questionnaire asking about the presence and severity of the possible side effects. The
      participants will then follow up in 1 week with the safety questionnaire and at 1 month with
      the safety questionnaire and the Autism Spectrum Rating Scale.

      Study Procedures:

      Investigators, including those involved in questionnaire and behavioral scales administration
      and fMRI scanning/interpreting will be blinded to which treatment group participants are in.
      Staff members in charge of applying tDCS will be aware of what treatment group the
      participant is in but will not be involved in analysis of data to ensure blinding of results.
      As far as the tDCS procedure goes, the device consists of a programmable current source with
      a rechargeable battery with two wires connected to electrodes in fabric pads. The device
      cannot be plugged into an outlet while the electrodes are connected, ensuring safety. tDCS
      pads are moistened with 0.9% normal saline and placed on the participant's scalp using
      elastic bands. During stimulation, the electrodes will apply 1 mA of constant DC electrical
      current. Current will be increased over 10-60 seconds. The current will be applied for no
      more than 20 minutes, after which the current is decreased over 10-60 seconds. In sham tDCS,
      the current is increased and then immediately decreased to provide sensations associated with
      tDCS (mild tingling or itching, which blinds the participant).

      Testing will take place before (on orientation day) and after tDCS. Baseline testing includes
      an ADOS-2 if deemed necessary, an abbreviated cognitive measure, interpretation of facial
      expressions, memory for faces, reading the mind in the eyes, triangle animations, cyberball
      /social ball throwing, dimensional card change sort, and caregiver-completed behavioral scale
      including the Autsim Spectrum Rating Scale.. Testing immediately after tDCS includes only the
      following: interpretation of facial expressions, memory for faces, reading the mind in the
      eyes, triangle animations, theory of mind, cyberball/social ball throwing, and dimensional
      card change sort.

      Participants with ASD will come in on designated orientation days and be assigned an
      alphanumeric identifier to ensure confidentiality. An initial safety screening will be done
      to ensure no exclusion criteria are met. Participants will then be randomly split into either
      a sham group or a treatment group. Baseline testing will be completed. Participants will then
      be allowed to explore and become acclimated with study equipment, and a mock MRI will be done
      on the first visit at the UTSW Advanced Imaging Research Center (AIRC).

      Participants will be desensitized to the sounds and tactile sensations of the fMRI
      environment while in a space similar to that of the scanner bore. Participants will practice
      remaining still within the mock MRI while viewing a movie, and biofeedback is used to train
      participants to keep their movement <1mm during practice periods of 10 minutes. Participants
      should be able to complete all of the screening in one visit. If participants cannot due to
      time constraints participants will be brought back in on a different day to complete the
      screening visit.

      The next time participants return, participants will be hooked up to vitals and eye movement
      monitoring and will be placed in the fMRI machine so the "before" scanning can begin. After
      this "before" scan, tDCS electrodes will be applied and participants will again be placed in
      the fMRI machine for the "during" scan. As soon as scanning begins, tDCS (either sham or
      treatment of 1 mA for 20 minutes of anodal tDCS administration to the Right Crus I/II area of
      the cerebellum) will begin as well. During tDCS treatment caregivers will receive a safety
      questionnaire for them to assess any side effects occurring in their child. After this scan,
      the tDCS electrode will be removed, and a final "after" fMRI scan will take place. The safety
      questionnaire will be given after tDCS at the end of the visit and behavioral tests are
      complete.The time estimated for all of this is about 90-180 minutes.

      The Safety Questionnaire will be assessed again with follow-up visits 1 week and 1 month
      afterwards using the same caregiver-completed scales.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Incidence of tDCS associated side effects assessed by tDCS Safety Assessment
time frame: Post-Intervention up to one month
description: Observe whether tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) is safe and easily tolerated using a tDCS Safety Assessment
measure: Change in Autism Spectrum Disorder Symptoms assessed by NEPSY-2 Subtests
time frame: Pre-Intervention at 1 week and Post-Intervention at 1 hour
description: Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, related to social behavior and cognition. The NEPSY-2 subtests include: Memory for Faces, Theory of Mind, and Affect Recognition. The NEPSY-2 subtests are designed to assess abilities related to memory, learning, and social perception.
measure: Change in Autism Spectrum Disorder Symptoms assessed by Reading the Mind in the Eyes
time frame: Pre-Intervention at 1 week and Post-Intervention at 1 hour
description: Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, related to social behavior and cognition. This will be assessed by Reading the Mind in the Eyes, a measure of complex mental state recognition.
measure: Change in Autism Spectrum Disorder Symptoms assessed by Triangle Animations/Social Perception Task
time frame: Pre-Intervention at 1 week and Post-Intervention at 1 hour
description: Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, related to social behavior and cognition. The Triangle Animations/ Social Perception Task assesses Theory of Mind mental functions such as belief and intention.
measure: Change in Autism Spectrum Disorder Symptoms assessed by Cyberball/Social Ball Throwing Task
time frame: Pre-Intervention at 1 week and Post-Intervention at 1 hour
description: Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, related to social behavior. The Cyberball/Social Ball Throwing Task assesses engagement in social interaction.
measure: Change in Autism Spectrum Disorder Symptoms assessed by Dimensional Change Card Sort
time frame: Pre-Intervention at 1 week and Post-Intervention at 1 hour
description: Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, related to cognition. The Dimensional Change Card Sort is a measure of cognitive flexibility, also known as task switching or set shifting.
measure: Change in Autism Spectrum Disorder Symptoms assessed by Autism Spectrum Rating Scale
time frame: Pre-Intervention at 1 week and Post-Intervention at 1 week and 1 month
description: Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, such as repetitive behaviors and hyperactivity. The Autism Spectrum Rating Scale (ASRS) is a nationally-standardized, norm-referenced checklist designed to identify symptoms, behaviors, and associated features of Autism Spectrum Disorders in children and adolescents. Using a five-point Likert rating scale (1- Never, 2- Rarely, 3- Occasionally, 4- Frequently, 5- Very Frequently), parents/caregivers are asked to evaluate how often they observed specific behaviors in the child or adolescent in areas such as socialization, communication, unusual behaviors, behavioral rigidity, sensory sensitivity, and self-regulation.
arm group label: Full Administration of Transcranial Direct Current Stimulation
arm group type: Experimental
description: Each subject will undergo psychosocial and behavioral assessments at a session prior to the administration of tDCS. The second session will include the tDCS Administration; a current of 1 mA will be administered over 20 minutes to the right crusI/II area of the cerebellum with a 15 second fade in period at the beginning and a 15 second fade out period at the end. During the tDCS administration, subjects will undergo functional MRI scanning. After the tDCS administration, subjects will repeat psychosocial and behavioral assessments.
arm group label: Sham Administration of Transcranial Direct Current Stimulation
arm group type: Sham Comparator
description: Each subject will undergo psychosocial and behavioral assessments at a session prior to the administration of tDCS. The second session will include the tDCS Administration; a current of 1mA increased over 15 seconds and immediately decreased over 15 seconds to provide sensation associated with tDCS. During the sham administration, subjects will undergo functional MRI scanning. After the tDCS administration, subjects will repeat psychosocial and behavioral assessments.
intervention type: Device
intervention name: tDCS
description: A current of 1 mA will be administered for 20 minutes of with either anodal or cathodal tDCS administration to the right crus I/II area of the cerebellum.
arm group label: Full Administration of Transcranial Direct Current Stimulation
arm group label: Sham Administration of Transcranial Direct Current Stimulation
criteria: 
gender: All
minimum age: 4 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Peter Tsai, MD, PhD
role: Principal Investigator
affiliation: University of Texas Southwestern Medical Center
last name: Peter Tsai, MD, PhD
phone: 214-648-3577
email: peter.tsai@utsouthwestern.edu
last name: Amy Magallanes
phone: 214-648-5155
email: amy.magallanes@utsouthwestern.edu
facility: 
status: Recruiting
facility: 
status: Recruiting
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Peter Tsai
investigator title: Assistant Professor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive
sharing ipd: No