<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/NCT03753191</url>
  </required_header>
  <id_info>
    <org_study_id>StartUp1.51</org_study_id>
    <nct_id>NCT03753191</nct_id>
  </id_info>
  <brief_title>The Effects of Transcranial Direct Current Stimulation on Executive Function in People With Mild to Moderate Dementia</brief_title>
  <official_title>The Effects of Transcranial Direct Current Stimulation on Executive Function in People With Mild to Moderate Dementia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hong Kong Polytechnic 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>
      To study the effects of transcranial direct current stimulation on executive function in&#xD;
      people with mild to moderate dementia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Extensive research had shown executive dysfunction in people with dementia (PWD) is&#xD;
      associated with functional abnormalities in prefrontal regions such as the right inferior&#xD;
      frontal gyrus (Right IFG) or the left dorsal lateral pre-frontal cortex (Left DLPFC) .&#xD;
      Clinical studies suggest that tDCS may be a useful therapeutic tool. Post-tDCS improvements&#xD;
      have also been shown in visuo-motor coordination of healthy controls and performance in&#xD;
      working memory. The aim of this study is to investigate the effect of tDCS stimulation over&#xD;
      left DLPFC or right IFG on attention, inhibition and working memory and their neural&#xD;
      correlates in people with dementia (PWD) and healthy controls (HC).This study is planned as a&#xD;
      double-blinded, randomized case-control interventional study with a duration of 30 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Anticipated">October 20, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</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>double-blinded, randomized case-control interventional study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>double-blinded, with randomized case-control</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Haemodynamic changes</measure>
    <time_frame>baseline and 5 minutes after tDCS</time_frame>
    <description>Change in hemodynamic level in two region of interest of prefrontal cortical regions, that is DLPFC and IFG</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trail Making Test</measure>
    <time_frame>baseline and 5 minutes after tDCS</time_frame>
    <description>change in Trail Making Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Behavior change</measure>
    <time_frame>baseline and 5 minutes after tDCS</time_frame>
    <description>Change in the Chinese Multiple Errands Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>N-back task</measure>
    <time_frame>baseline and 5 minutes after tDCS</time_frame>
    <description>Change in N-back task</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stop-signal task</measure>
    <time_frame>baseline and 5 minutes after tDCS</time_frame>
    <description>Change in Stop-signal task</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Dementia</condition>
  <condition>Executive Function</condition>
  <condition>Transcranial Direct Current Stimulation</condition>
  <arm_group>
    <arm_group_label>People with Dementia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twenty subjects each group will be randomized to receive either anodal tDCS or shame tDCS over the Right iFG or Left DLPFC. A 2mA direct current for active tDCS (current density : .057 mA/cm2) with a 20 mins stimulation period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Twenty subjects each group will be randomized to receive either anodal tDCS or shame tDCS over the Right iFG or Left DLPFC. After a fade in period of 10s to mimic initial tDCS peripheral skin sensations, the stimulator will be turned off in order to prevent the induction of any neuromodulatory effect.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcranial direct current stimulation</intervention_name>
    <description>Each subject will undergo one tDCS stimulation session lasting for 20 minutes. A constant current of 2 mA will be applied with a linear fade in, fade out of 10 seconds to prevent electrical transients.</description>
    <arm_group_label>Health Control</arm_group_label>
    <arm_group_label>People with Dementia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PWD must be aged at least 65 years or above when informed consent is obtained in the&#xD;
             presence of his / her first degree relatives.&#xD;
&#xD;
          -  PWD must meet criteria of DSM-V for dementia as well as for historical diagnosis of&#xD;
             dementia.&#xD;
&#xD;
          -  PWD must have a Chinese MoCA score &gt; 19 (mild to moderate cognitive deficits) at&#xD;
             screening.&#xD;
&#xD;
          -  Subjects (both PWD and HC) must be physically healthy, and must be able to understand&#xD;
             and be willing to sign the informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject with major neurological illness.&#xD;
&#xD;
          -  Subject with other diagnosed psychiatric disorders&#xD;
&#xD;
          -  Subjects reported with history of substance abuse, which including alcohol, drugs or&#xD;
             any medication which is indicative of chronic abuse.&#xD;
&#xD;
          -  Failures to comply with the study protocol or to follow the instructions.&#xD;
&#xD;
          -  Self-reported with known skin diseases or skin allergy history.&#xD;
&#xD;
          -  Self-reported with metallic implants, dentures&#xD;
&#xD;
          -  Self-reported with history of claustrophobia. (This is excluded because subject needs&#xD;
             to stay in a quiet room with the head-mounted fNIRS and tDCS, which may elicit their&#xD;
             feeling of anxiety)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frank LAI, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Frank LAI, PhD</last_name>
    <phone>2766 6749</phone>
    <email>frank.hy.lai@polyu.edu.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Hong Kong Polytechnic University</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>frank Lai, PhD</last_name>
    </contact>
    <contact_backup>
      <last_name>Daniel Chan, BSc</last_name>
      <email>daniel430.chan@polyu.edu.hk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <reference>
    <citation>Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901. doi: 10.1212/wnl.57.10.1899.</citation>
    <PMID>11723286</PMID>
  </reference>
  <reference>
    <citation>Liebetanz D, Nitsche MA, Tergau F, Paulus W. Pharmacological approach to the mechanisms of transcranial DC-stimulation-induced after-effects of human motor cortex excitability. Brain. 2002 Oct;125(Pt 10):2238-47. doi: 10.1093/brain/awf238.</citation>
    <PMID>12244081</PMID>
  </reference>
  <results_reference>
    <citation>Antal A, Varga ET, Kincses TZ, Nitsche MA, Paulus W. Oscillatory brain activity and transcranial direct current stimulation in humans. Neuroreport. 2004 Jun 7;15(8):1307-10. doi: 10.1097/01.wnr.0000127460.08361.84.</citation>
    <PMID>15167555</PMID>
  </results_reference>
  <results_reference>
    <citation>Zaehle T, Sandmann P, Thorne JD, Jancke L, Herrmann CS. Transcranial direct current stimulation of the prefrontal cortex modulates working memory performance: combined behavioural and electrophysiological evidence. BMC Neurosci. 2011 Jan 6;12:2. doi: 10.1186/1471-2202-12-2.</citation>
    <PMID>21211016</PMID>
  </results_reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>November 17, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>October 20, 2020</last_update_submitted>
  <last_update_submitted_qc>October 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>Dr Frank LAI</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>Dementia</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/NCT03753191
org study id: StartUp1.51
nct id: NCT03753191
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To study the effects of transcranial direct current stimulation on executive function in
      people with mild to moderate dementia
Extensive research had shown executive dysfunction in people with dementia (PWD) is
      associated with functional abnormalities in prefrontal regions such as the right inferior
      frontal gyrus (Right IFG) or the left dorsal lateral pre-frontal cortex (Left DLPFC) .
      Clinical studies suggest that tDCS may be a useful therapeutic tool. Post-tDCS improvements
      have also been shown in visuo-motor coordination of healthy controls and performance in
      working memory. The aim of this study is to investigate the effect of tDCS stimulation over
      left DLPFC or right IFG on attention, inhibition and working memory and their neural
      correlates in people with dementia (PWD) and healthy controls (HC).This study is planned as a
      double-blinded, randomized case-control interventional study with a duration of 30 months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: double-blinded, randomized case-control interventional study
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: double-blinded, with randomized case-control
measure: Haemodynamic changes
time frame: baseline and 5 minutes after tDCS
description: Change in hemodynamic level in two region of interest of prefrontal cortical regions, that is DLPFC and IFG
measure: Trail Making Test
time frame: baseline and 5 minutes after tDCS
description: change in Trail Making Test
measure: Behavior change
time frame: baseline and 5 minutes after tDCS
description: Change in the Chinese Multiple Errands Test
measure: N-back task
time frame: baseline and 5 minutes after tDCS
description: Change in N-back task
measure: Stop-signal task
time frame: baseline and 5 minutes after tDCS
description: Change in Stop-signal task
arm group label: People with Dementia
arm group type: Experimental
description: Twenty subjects each group will be randomized to receive either anodal tDCS or shame tDCS over the Right iFG or Left DLPFC. A 2mA direct current for active tDCS (current density : .057 mA/cm2) with a 20 mins stimulation period
arm group label: Health Control
arm group type: Sham Comparator
description: Twenty subjects each group will be randomized to receive either anodal tDCS or shame tDCS over the Right iFG or Left DLPFC. After a fade in period of 10s to mimic initial tDCS peripheral skin sensations, the stimulator will be turned off in order to prevent the induction of any neuromodulatory effect.
intervention type: Device
intervention name: transcranial direct current stimulation
description: Each subject will undergo one tDCS stimulation session lasting for 20 minutes. A constant current of 2 mA will be applied with a linear fade in, fade out of 10 seconds to prevent electrical transients.
arm group label: Health Control
arm group label: People with Dementia
criteria: 
gender: All
minimum age: 65 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Frank LAI, PhD
role: Principal Investigator
affiliation: Assistant Professor
last name: Frank LAI, PhD
phone: 2766 6749
email: frank.hy.lai@polyu.edu.hk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Hong Kong
citation: Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901. doi: 10.1212/wnl.57.10.1899.
PMID: 11723286
citation: Liebetanz D, Nitsche MA, Tergau F, Paulus W. Pharmacological approach to the mechanisms of transcranial DC-stimulation-induced after-effects of human motor cortex excitability. Brain. 2002 Oct;125(Pt 10):2238-47. doi: 10.1093/brain/awf238.
PMID: 12244081
citation: Antal A, Varga ET, Kincses TZ, Nitsche MA, Paulus W. Oscillatory brain activity and transcranial direct current stimulation in humans. Neuroreport. 2004 Jun 7;15(8):1307-10. doi: 10.1097/01.wnr.0000127460.08361.84.
PMID: 15167555
citation: Zaehle T, Sandmann P, Thorne JD, Jancke L, Herrmann CS. Transcranial direct current stimulation of the prefrontal cortex modulates working memory performance: combined behavioural and electrophysiological evidence. BMC Neurosci. 2011 Jan 6;12:2. doi: 10.1186/1471-2202-12-2.
PMID: 21211016
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: Dr Frank LAI
investigator title: Assistant Professor
mesh term: Dementia
sharing ipd: No