<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/NCT04504630</url>
  </required_header>
  <id_info>
    <org_study_id>STU-2019-1769</org_study_id>
    <nct_id>NCT04504630</nct_id>
  </id_info>
  <brief_title>Noninvasive Brain Stimulation on Memory in Individuals With Mild Cognitive Impairment and History of Brain Injury</brief_title>
  <official_title>High-Definition Transcranial Direct Current Stimulation on Episodic Memory in Individuals With Amnestic Mild Cognitive Impairment and History of TBI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>U.S. Army Medical Research and Development Command</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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 study will examine the efficacy of high definition transcranial direct current&#xD;
      stimulation (HD-tDCS) and its influence on episodic memory in patients with amnestic mild&#xD;
      cognitive impairment and a history of Traumatic brain injury. Ten sessions of HD-tDCS to the&#xD;
      dorsal anterior cingulate region is expected to result in improvements in episodic memory&#xD;
      measures immediately following the last session and at a 3-month follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 5, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change from baseline in episodic memory functioning immediately following the last HD-tDCS session and at 3-month follow-up</measure>
    <time_frame>Baseline, immediately following last HD-tDCS session, and again at 3-month follow-up</time_frame>
    <description>Episodic verbal memory will be assessed with the Hopkins Verbal Learning Test-Revised (HVLT-R). This measures rate of learning for verbal material and the amount retained after a delay. Episodic visual memory will be assessed with the Brief Visuospatial Memory Test-Revised (BVMT-R). This measures rate of learning for visual material and the amount retained after a delay. Both measures provide standardized scores based on a normative sample adjusted for key demographic factors, with higher scores reflecting better performances.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Amnestic Mild Cognitive Impairment</condition>
  <condition>Traumatic Brain Injury</condition>
  <condition>Mild Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Active HD-tDCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks, with episodic memory tasks completed at baseline, immediate follow-up after session 10, and a 3-month follow-up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham HD-tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants will receive 10 sessions of sham stimulation across 2 weeks, with episodic memory tasks completed at baseline, immediate follow-up after session 10, and a 3-month follow-up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High Definition Transcranial Direct Current Stimulation</intervention_name>
    <description>This wireless device delivers a very low electrical current to focused regions on the scalp in order to modulate underlying brain circuits to promote neuroplasticity. The device will be fitted onto a neoprene EEG cap, with 1 anode electrode placed and surrounded by 4 cathode electrodes in a ring pattern. Electrical stimulation will be applied using a constant voltage cortical stimulator (Model D185, Digitimer Ltd, UK, maximal output 1000 V/1.5 A) with single square-wave 50-μs pulses (0.1 A/μs rise time).</description>
    <arm_group_label>Active HD-tDCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham HD-tDCS</intervention_name>
    <description>Sham HD-tDCS</description>
    <arm_group_label>Sham HD-tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 50 and older&#xD;
&#xD;
          -  Native English speakers&#xD;
&#xD;
          -  12 years of education or higher&#xD;
&#xD;
          -  Active diagnosis of aMCI&#xD;
&#xD;
          -  History of TBI based on VA/DOD criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  TBI within the past 2 years&#xD;
&#xD;
          -  Lifetime history of stroke, transient ischemic attack, heart attack, or congestive&#xD;
             heart failure&#xD;
&#xD;
          -  Lifetime history of epilepsy&#xD;
&#xD;
          -  Major psychiatric disorders (i.e., posttraumatic stress disorder, bipolar disorder,&#xD;
             schizophrenia)&#xD;
&#xD;
          -  Substance use disorder&#xD;
&#xD;
          -  Has metal fragments in head&#xD;
&#xD;
          -  Taking medications that may interact with the HD-tDCS effect (i.e., amphetamines,&#xD;
             L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, dextromethorphan,&#xD;
             D-cycloserine, flunarizine, or ropinirole)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian B LoBue, PhD</last_name>
      <phone>214-648-7226</phone>
      <email>christian.lobue@utsw.edu</email>
    </contact>
    <contact_backup>
      <last_name>Nyaz Didehbani, PhD</last_name>
      <phone>214-648-7226</phone>
      <email>nyaz.didehbani@utsw.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>April 3, 2023</last_update_submitted>
  <last_update_submitted_qc>April 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2023</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>Christian Lobue</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>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Brain Concussion</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>There is a plan to upload study data to the FITBIR repository system within one year of completion.</ipd_description>
  </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/NCT04504630
org study id: STU-2019-1769
nct id: NCT04504630
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study will examine the efficacy of high definition transcranial direct current
      stimulation (HD-tDCS) and its influence on episodic memory in patients with amnestic mild
      cognitive impairment and a history of Traumatic brain injury. Ten sessions of HD-tDCS to the
      dorsal anterior cingulate region is expected to result in improvements in episodic memory
      measures immediately following the last session and at a 3-month follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Mean change from baseline in episodic memory functioning immediately following the last HD-tDCS session and at 3-month follow-up
time frame: Baseline, immediately following last HD-tDCS session, and again at 3-month follow-up
description: Episodic verbal memory will be assessed with the Hopkins Verbal Learning Test-Revised (HVLT-R). This measures rate of learning for verbal material and the amount retained after a delay. Episodic visual memory will be assessed with the Brief Visuospatial Memory Test-Revised (BVMT-R). This measures rate of learning for visual material and the amount retained after a delay. Both measures provide standardized scores based on a normative sample adjusted for key demographic factors, with higher scores reflecting better performances.
arm group label: Active HD-tDCS
arm group type: Active Comparator
description: Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks, with episodic memory tasks completed at baseline, immediate follow-up after session 10, and a 3-month follow-up.
arm group label: Sham HD-tDCS
arm group type: Sham Comparator
description: Participants will receive 10 sessions of sham stimulation across 2 weeks, with episodic memory tasks completed at baseline, immediate follow-up after session 10, and a 3-month follow-up.
intervention type: Device
intervention name: High Definition Transcranial Direct Current Stimulation
description: This wireless device delivers a very low electrical current to focused regions on the scalp in order to modulate underlying brain circuits to promote neuroplasticity. The device will be fitted onto a neoprene EEG cap, with 1 anode electrode placed and surrounded by 4 cathode electrodes in a ring pattern. Electrical stimulation will be applied using a constant voltage cortical stimulator (Model D185, Digitimer Ltd, UK, maximal output 1000 V/1.5 A) with single square-wave 50-μs pulses (0.1 A/μs rise time).
arm group label: Active HD-tDCS
intervention type: Device
intervention name: Sham HD-tDCS
description: Sham HD-tDCS
arm group label: Sham HD-tDCS
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Christian Lobue
investigator title: Assistant Professor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Brain Concussion
mesh term: Wounds and Injuries
mesh term: Cognitive Dysfunction
sharing ipd: Yes
ipd description: There is a plan to upload study data to the FITBIR repository system within one year of completion.