<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/NCT03255837</url>
  </required_header>
  <id_info>
    <org_study_id>GN17MH365</org_study_id>
    <nct_id>NCT03255837</nct_id>
  </id_info>
  <brief_title>tDCS on Working Memory (WM) in Adults With ASD</brief_title>
  <official_title>A Single Blind, Randomized Controlled Trial of Anodal Transcranial Direct-current Stimulation (tDCS) Against Cathodal and Sham Stimulation in Adults With High-Functioning Autism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NHS Greater Glasgow and Clyde</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Glasgow</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NHS Greater Glasgow and Clyde</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>
      This study will involve an experiment in individuals with Autism Spectrum Disorder (ASD)&#xD;
      comparing their performance on a working memory task before, during and after non-invasive&#xD;
      brain stimulation (tDCS) compared to a control group in a 3x3 factorial design. How the&#xD;
      stimulation affects performance on the task will be assessed, along with the impact of the&#xD;
      intervention on the individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many studies have examined working memory in people with autism spectrum disorder as working&#xD;
      memory deficits in individuals with autism spectrum disorder leads to multiple difficulties&#xD;
      associated with behaviour regulation, cognitive flexibility, abstract thinking, and focusing&#xD;
      and sustaining attention. Evidence suggests that transcranial Direct Current Stimulation on&#xD;
      the left dorsolateral prefrontal cortex leads to an increase in working memory performance in&#xD;
      typically developing individuals. This may have important benefits for people with autism&#xD;
      spectrum disorder since autism spectrum disorder is known to be associated with working&#xD;
      memory deficiencies. This study will build on a pilot study conducted in 2014, the experiment&#xD;
      tested participants working memory scores on an N-back test, after receiving anodal (positive&#xD;
      stimulation) stimulation for 15 minutes over the left dorsolateral prefrontal cortex. This&#xD;
      task requires the participant to perform multiple cognitive operations, including encoding of&#xD;
      new stimuli, updating and maintaining past stimuli, and recognising and responding to whether&#xD;
      each new stimulus matches the three-back stimulus. Participants are presented with a random&#xD;
      set of ten letters (from A-Z). A different letter will be displayed every 2s, participants&#xD;
      will be required to respond (key press 1) if the presented letter was the same as the letter&#xD;
      presented three stimuli previously (a target). If it was not a target, participants were&#xD;
      required to respond with key press 2. In this test, a total of 30 correct responses are&#xD;
      possible. Participants will perform the task three times to reduce variability. Accuracy&#xD;
      (number of correct responses), error rate (number of incorrect responses), and reaction time&#xD;
      (interval between target presentation and pressing 1 or 2) will be recorded. Based on the&#xD;
      findings from the pilot study, a full study will be conducted to investigate the effects of&#xD;
      anodal transcranial Direct Current Stimulation on adults with high-functioning autism, as&#xD;
      well as test whether the effects of transcranial Direct Current Stimulation on dorsolateral&#xD;
      prefrontal cortex is dependent on polarity (anodal versus cathodal (negative stimulation)&#xD;
      stimulation).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 26, 2018</start_date>
  <completion_date type="Actual">December 21, 2018</completion_date>
  <primary_completion_date type="Actual">December 21, 2018</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>
    <intervention_model_description>Each participant will receive the same 3 kinds of transcranial stimulation. However, the order in which they receive them will be randomly allocated.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants will be unaware of the order in which they receive the transcranial stimulation condition (anodal, cathodal, sham).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Working memory accuracy score compared to typically developed controls scores.</measure>
    <time_frame>Change from baseline (before stimulation) to after stimulation (1 week)</time_frame>
    <description>Result of N-back memory task</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in working memory accuracy score between adults with ASD and healthy controls</measure>
    <time_frame>Before stimulation</time_frame>
    <description>Result of N-back memory task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in working memory accuracy score between adults with ASD and healthy controls</measure>
    <time_frame>After stimulation (1 week)</time_frame>
    <description>Result of N-back memory task</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Transcranial direct current stimulation (tDCS) - anodal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcranial direct current stimulation - anodal (positive) 1.5 millamps for 15 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transcranial direct current stimulation (tDCS) - cathodal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcranial direct current stimulation - cathodal (negative) 1.5 millamps for 15 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transcranial direct current stimulation (tDCS) - sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Transcranial direct current stimulation - sham session 15 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial direct current stimulation (tDCS)</intervention_name>
    <description>Transcranial Direct Current Stimulation (tDCS, a form of non-invasive brain stimulation) on the left dorsolateral prefrontal cortex (DLPFC)</description>
    <arm_group_label>Transcranial direct current stimulation (tDCS) - anodal</arm_group_label>
    <arm_group_label>Transcranial direct current stimulation (tDCS) - cathodal</arm_group_label>
    <arm_group_label>Transcranial direct current stimulation (tDCS) - sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical diagnosis of ASD&#xD;
&#xD;
          -  right handed&#xD;
&#xD;
          -  speaks English fluently&#xD;
&#xD;
          -  normal vision or corrected to normal&#xD;
&#xD;
          -  passing tDCS safety screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  participants who do not understand verbal or written English (i.e would be in need of&#xD;
             translators)&#xD;
&#xD;
          -  participants that have ever suffered from epilepsy, febrile convulsions in infancy or&#xD;
             had recurrent fainting spells&#xD;
&#xD;
          -  family history of epilepsy&#xD;
&#xD;
          -  has a heart pacemaker, cochlear implant, medication pump, surgical clips&#xD;
&#xD;
          -  has drunk more than 3 units of alcohol in the last 24 hours&#xD;
&#xD;
          -  suffers from migraines&#xD;
&#xD;
          -  metal in the head, implanted brain medical devices&#xD;
&#xD;
          -  has undergone a neurosurgical procedure&#xD;
&#xD;
          -  has had more than one cup of coffee, or other sources of caffeine in the last hour&#xD;
&#xD;
          -  taking any unprescribed or prescribed medication that might effect tDCS&#xD;
&#xD;
          -  medications or psychoactive drugs that can lower seizure threshold [imipramine,&#xD;
             amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, clozapine,&#xD;
             foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, (MDMA, ecstasy),&#xD;
             phencyclidine (PCP, angel dust), ketamine, gamma-hydroxybutyrate (GHB), alcohol,&#xD;
             theophylline]&#xD;
&#xD;
          -  withdrawal from alcohol, barbiturates, benzodiazepines, meprobamate, chloral hydrate&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Craig Melville, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Glasgo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Glasgow</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Transcranial Stimulation</keyword>
  <keyword>Memory</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autism Spectrum Disorder</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/NCT03255837
org study id: GN17MH365
nct id: NCT03255837
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will involve an experiment in individuals with Autism Spectrum Disorder (ASD)
      comparing their performance on a working memory task before, during and after non-invasive
      brain stimulation (tDCS) compared to a control group in a 3x3 factorial design. How the
      stimulation affects performance on the task will be assessed, along with the impact of the
      intervention on the individuals.
Many studies have examined working memory in people with autism spectrum disorder as working
      memory deficits in individuals with autism spectrum disorder leads to multiple difficulties
      associated with behaviour regulation, cognitive flexibility, abstract thinking, and focusing
      and sustaining attention. Evidence suggests that transcranial Direct Current Stimulation on
      the left dorsolateral prefrontal cortex leads to an increase in working memory performance in
      typically developing individuals. This may have important benefits for people with autism
      spectrum disorder since autism spectrum disorder is known to be associated with working
      memory deficiencies. This study will build on a pilot study conducted in 2014, the experiment
      tested participants working memory scores on an N-back test, after receiving anodal (positive
      stimulation) stimulation for 15 minutes over the left dorsolateral prefrontal cortex. This
      task requires the participant to perform multiple cognitive operations, including encoding of
      new stimuli, updating and maintaining past stimuli, and recognising and responding to whether
      each new stimulus matches the three-back stimulus. Participants are presented with a random
      set of ten letters (from A-Z). A different letter will be displayed every 2s, participants
      will be required to respond (key press 1) if the presented letter was the same as the letter
      presented three stimuli previously (a target). If it was not a target, participants were
      required to respond with key press 2. In this test, a total of 30 correct responses are
      possible. Participants will perform the task three times to reduce variability. Accuracy
      (number of correct responses), error rate (number of incorrect responses), and reaction time
      (interval between target presentation and pressing 1 or 2) will be recorded. Based on the
      findings from the pilot study, a full study will be conducted to investigate the effects of
      anodal transcranial Direct Current Stimulation on adults with high-functioning autism, as
      well as test whether the effects of transcranial Direct Current Stimulation on dorsolateral
      prefrontal cortex is dependent on polarity (anodal versus cathodal (negative stimulation)
      stimulation).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Each participant will receive the same 3 kinds of transcranial stimulation. However, the order in which they receive them will be randomly allocated.
primary purpose: Supportive Care
masking: Single (Participant)
masking description: Participants will be unaware of the order in which they receive the transcranial stimulation condition (anodal, cathodal, sham).
measure: Working memory accuracy score compared to typically developed controls scores.
time frame: Change from baseline (before stimulation) to after stimulation (1 week)
description: Result of N-back memory task
measure: Difference in working memory accuracy score between adults with ASD and healthy controls
time frame: Before stimulation
description: Result of N-back memory task
measure: Difference in working memory accuracy score between adults with ASD and healthy controls
time frame: After stimulation (1 week)
description: Result of N-back memory task
arm group label: Transcranial direct current stimulation (tDCS) - anodal
arm group type: Experimental
description: Transcranial direct current stimulation - anodal (positive) 1.5 millamps for 15 minutes
arm group label: Transcranial direct current stimulation (tDCS) - cathodal
arm group type: Experimental
description: Transcranial direct current stimulation - cathodal (negative) 1.5 millamps for 15 minutes
arm group label: Transcranial direct current stimulation (tDCS) - sham
arm group type: Sham Comparator
description: Transcranial direct current stimulation - sham session 15 minutes
intervention type: Device
intervention name: Transcranial direct current stimulation (tDCS)
description: Transcranial Direct Current Stimulation (tDCS, a form of non-invasive brain stimulation) on the left dorsolateral prefrontal cortex (DLPFC)
arm group label: Transcranial direct current stimulation (tDCS) - anodal
arm group label: Transcranial direct current stimulation (tDCS) - cathodal
arm group label: Transcranial direct current stimulation (tDCS) - sham
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Craig Melville, MD
role: Study Director
affiliation: University of Glasgo
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Autism Spectrum Disorder
sharing ipd: No