<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/NCT03807934</url>
  </required_header>
  <id_info>
    <org_study_id>1303018</org_study_id>
    <nct_id>NCT03807934</nct_id>
  </id_info>
  <brief_title>Cerebral Excitability and Cognitive Performance</brief_title>
  <official_title>Cerebral Excitability and Cognitive Performance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tufts University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tufts University</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 investigates the perceptual and cognitive influences of low-intensity electrical&#xD;
      brain stimulation (transcranial direct current stimulation; tDCS), versus control (sham)&#xD;
      conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">April 15, 2013</start_date>
  <completion_date type="Anticipated">April 14, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 14, 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>Crossover Assignment</intervention_model>
    <intervention_model_description>Repeated-measures crossover design.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual perceptual performance</measure>
    <time_frame>36 weeks</time_frame>
    <description>Ability to accurately and efficiently perceive perceptual information, including threat detection, local contrast gradient detection, face memory, and intent appraisal. All are computerized tasks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Verbal cognitive performance</measure>
    <time_frame>36 weeks</time_frame>
    <description>Ability to accurately and efficiently process verbal information, including verbal cued free association tasks, verbal long-term memory, and language comprehension. All are computerized tasks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spatial cognitive performance</measure>
    <time_frame>72 weeks</time_frame>
    <description>Ability to accurately and efficiently process spatial information, including map learning, virtual urban navigation, and mental rotation. All are computerized tasks.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Cognitive Change</condition>
  <arm_group>
    <arm_group_label>Active High-Definition Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active high-definition stimulation of targeted brain regions involved in perception and cognition.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham High-Definition Stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham high-definition stimulation of targeted brain regions involved in perception and cognition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems</intervention_name>
    <description>Active (at or below 2mA) versus sham (at or below 0.5mA) stimulation targeting brain regions engaged during verbal and/or spatial perceptual and cognitive processing. Brain stimulation devices are not currently regulated by the United States Food and Drug Administration. Local IRB has determined the devices to be non-significant risk (NSR) devices via abbreviated investigational device exemption (IDE) procedure.</description>
    <arm_group_label>Active High-Definition Stimulation</arm_group_label>
    <arm_group_label>Sham High-Definition Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Between ages of 18-65.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of adverse reaction to tDCS (trans-cranial direct current stimulation).&#xD;
&#xD;
          -  History of seizure activity.&#xD;
&#xD;
          -  History of head injury (including neurosurgery).&#xD;
&#xD;
          -  History of illness causing brain injury.&#xD;
&#xD;
          -  History of other brain-related condition (such as traumatic brain injury).&#xD;
&#xD;
          -  History of diagnosis with a neurological or psychiatric disorder.&#xD;
&#xD;
          -  History of metal in head (outside of mouth), such as shrapnel, surgical clips, or&#xD;
             fragments from welding or metalwork.&#xD;
&#xD;
          -  History of sensitive scalp.&#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>
  <location>
    <facility>
      <name>Tufts University</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Brunye TT, Hussey EK, Fontes EB, Ward N. Modulating Applied Task Performance via Transcranial Electrical Stimulation. Front Hum Neurosci. 2019 Apr 30;13:140. doi: 10.3389/fnhum.2019.00140. eCollection 2019.</citation>
    <PMID>31114491</PMID>
  </results_reference>
  <results_reference>
    <citation>Brunye TT, Smith AM, Horner CB, Thomas AK. Verbal long-term memory is enhanced by retrieval practice but impaired by prefrontal direct current stimulation. Brain Cogn. 2018 Dec;128:80-88. doi: 10.1016/j.bandc.2018.09.008. Epub 2018 Nov 8.</citation>
    <PMID>30414699</PMID>
  </results_reference>
  <results_reference>
    <citation>Brunye TT. Modulating Spatial Processes and Navigation via Transcranial Electrical Stimulation: A Mini Review. Front Hum Neurosci. 2018 Jan 9;11:649. doi: 10.3389/fnhum.2017.00649. eCollection 2017.</citation>
    <PMID>29375346</PMID>
  </results_reference>
  <results_reference>
    <citation>Brunye TT, Moran JM, Cantelon J, Holmes A, Eddy MD, Mahoney CR, Taylor HA. Increasing breadth of semantic associations with left frontopolar direct current brain stimulation: a role for individual differences. Neuroreport. 2015 Mar 25;26(5):296-301. doi: 10.1097/WNR.0000000000000348.</citation>
    <PMID>25714417</PMID>
  </results_reference>
  <results_reference>
    <citation>Brunye TT, Holmes A, Cantelon J, Eddy MD, Gardony AL, Mahoney CR, Taylor HA. Direct current brain stimulation enhances navigation efficiency in individuals with low spatial sense of direction. Neuroreport. 2014 Oct 22;25(15):1175-9. doi: 10.1097/WNR.0000000000000214.</citation>
    <PMID>25144391</PMID>
  </results_reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>April 2, 2021</last_update_submitted>
  <last_update_submitted_qc>April 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tufts University</investigator_affiliation>
    <investigator_full_name>Tad Brunye</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>transcranial direct current stimulation</keyword>
  <keyword>cognitive psychology</keyword>
  <keyword>noninvasive brain stimulation</keyword>
  <keyword>electrical brain stimulation</keyword>
  <pending_results>
    <submitted>March 8, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03807934
org study id: 1303018
nct id: NCT03807934
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigates the perceptual and cognitive influences of low-intensity electrical
      brain stimulation (transcranial direct current stimulation; tDCS), versus control (sham)
      conditions.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Repeated-measures crossover design.
primary purpose: Basic Science
masking: Single (Participant)
measure: Visual perceptual performance
time frame: 36 weeks
description: Ability to accurately and efficiently perceive perceptual information, including threat detection, local contrast gradient detection, face memory, and intent appraisal. All are computerized tasks.
measure: Verbal cognitive performance
time frame: 36 weeks
description: Ability to accurately and efficiently process verbal information, including verbal cued free association tasks, verbal long-term memory, and language comprehension. All are computerized tasks.
measure: Spatial cognitive performance
time frame: 72 weeks
description: Ability to accurately and efficiently process spatial information, including map learning, virtual urban navigation, and mental rotation. All are computerized tasks.
arm group label: Active High-Definition Stimulation
arm group type: Experimental
description: Active high-definition stimulation of targeted brain regions involved in perception and cognition.
arm group label: Sham High-Definition Stimulation
arm group type: Sham Comparator
description: Sham high-definition stimulation of targeted brain regions involved in perception and cognition.
intervention type: Other
intervention name: Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems
description: Active (at or below 2mA) versus sham (at or below 0.5mA) stimulation targeting brain regions engaged during verbal and/or spatial perceptual and cognitive processing. Brain stimulation devices are not currently regulated by the United States Food and Drug Administration. Local IRB has determined the devices to be non-significant risk (NSR) devices via abbreviated investigational device exemption (IDE) procedure.
arm group label: Active High-Definition Stimulation
arm group label: Sham High-Definition Stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Brunye TT, Hussey EK, Fontes EB, Ward N. Modulating Applied Task Performance via Transcranial Electrical Stimulation. Front Hum Neurosci. 2019 Apr 30;13:140. doi: 10.3389/fnhum.2019.00140. eCollection 2019.
PMID: 31114491
citation: Brunye TT, Smith AM, Horner CB, Thomas AK. Verbal long-term memory is enhanced by retrieval practice but impaired by prefrontal direct current stimulation. Brain Cogn. 2018 Dec;128:80-88. doi: 10.1016/j.bandc.2018.09.008. Epub 2018 Nov 8.
PMID: 30414699
citation: Brunye TT. Modulating Spatial Processes and Navigation via Transcranial Electrical Stimulation: A Mini Review. Front Hum Neurosci. 2018 Jan 9;11:649. doi: 10.3389/fnhum.2017.00649. eCollection 2017.
PMID: 29375346
citation: Brunye TT, Moran JM, Cantelon J, Holmes A, Eddy MD, Mahoney CR, Taylor HA. Increasing breadth of semantic associations with left frontopolar direct current brain stimulation: a role for individual differences. Neuroreport. 2015 Mar 25;26(5):296-301. doi: 10.1097/WNR.0000000000000348.
PMID: 25714417
citation: Brunye TT, Holmes A, Cantelon J, Eddy MD, Gardony AL, Mahoney CR, Taylor HA. Direct current brain stimulation enhances navigation efficiency in individuals with low spatial sense of direction. Neuroreport. 2014 Oct 22;25(15):1175-9. doi: 10.1097/WNR.0000000000000214.
PMID: 25144391
responsible party type: Principal Investigator
investigator affiliation: Tufts University
investigator full name: Tad Brunye
investigator title: PI
submitted: March 8, 2023