<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/NCT02227953</url>
  </required_header>
  <id_info>
    <org_study_id>SMC 2014-04-025</org_study_id>
    <nct_id>NCT02227953</nct_id>
  </id_info>
  <brief_title>A Pilot Study of tDCS for Mild to Moderate Alzhemier's Disease</brief_title>
  <official_title>A Pilot Study for the Improvement of Cognitive Function (ADAS-Cog 11) After Transcranial Direct Current Stimulation in Mild to Moderate Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ybrain Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this preliminary study is to investigate whether the transcranial&#xD;
      direct current stimulation (tDCS) improves the cognitive function in patients with&#xD;
      Alzheimer's disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty patients were recruited and randomized to receive either real or sham-tDCS over the&#xD;
      left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Their legally&#xD;
      responsible caregivers were provided with mobile tDCS device, and were instructed to use it&#xD;
      on the patients at home. 30-minute session of the stimulation were applied everyday in the&#xD;
      morning for 12 weeks. The patients were evaluated at baseline, at week 6 and 12.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cognitive function</measure>
    <time_frame>from baseline to Week 6 and Week 12</time_frame>
    <description>Measured by ADAS-Cog 11</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in questionnaire</measure>
    <time_frame>from baseline to Week 12</time_frame>
    <description>Measured by I-PAQ (International Physical Activity Questionnaire), Quality of Life Scale, KDSQ (Korean Dementia Screening Questionnaire), and Prospective and retrospective memory questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognitive function</measure>
    <time_frame>from baseline to Week 6 and Week 12</time_frame>
    <description>Measured by Korean version of Montreal Cognitive Assessment (K-MoCA), Korean version of Mini Mental Status Examination (K-MMSE), and Clinical Dementia Rating - Sum of Boxes(CDR-SOB)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Korean version of Geriatric Depression Scale (K-GDS)</measure>
    <time_frame>from baseline to Week 6 and Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in activities of daily living</measure>
    <time_frame>from baseline to Week 12</time_frame>
    <description>Measured by Korean version of Bayer ADL (K-ADL) and S-IADL (Seoul-Instrumental Activities of Daily Living score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in behavioral symptoms</measure>
    <time_frame>from baseline to Week 6 and Week 12</time_frame>
    <description>Measured by Neuropsychiatric Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Clinician's Interview-Based Impression of Change Plus (CIBIC plus)</measure>
    <time_frame>from baseline to Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in tDCS feedback</measure>
    <time_frame>Week 2, 4, 6 and 12</time_frame>
    <description>Measured by tDCS feedback questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>YBand (YDT-201N)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>transcranial Direct Current Stimulation (tDCS) application 7 days a week for 12 weeks (total of 84 applications)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham-Yband (YDT-201N)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>sham-tDCS application 7 days a week for 12 weeks (total of 84 applications)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Yband (YDT-201N)</intervention_name>
    <description>transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 20 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)</description>
    <arm_group_label>YBand (YDT-201N)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sham-Yband (YDT-201N)</intervention_name>
    <description>transcranial Direct Current Stimulation (tDCS) 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)</description>
    <arm_group_label>sham-Yband (YDT-201N)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who have Korean version of Mini Mental Status Examination score 10 to 24&#xD;
&#xD;
          -  Subjects who have SVLT and RCFT delayed recall test scores lower than 1.5SD&#xD;
&#xD;
          -  Subjects who have had other cognitive impairments besides memory&#xD;
&#xD;
          -  Subjects who have Seoul-Instrumental Activities of Daily Living score (S-IADL) of 8 or&#xD;
             more.&#xD;
&#xD;
          -  Subjects who are only dementia of Alzheimer's type&#xD;
&#xD;
          -  Subjects who are right-handed&#xD;
&#xD;
          -  Subjects who are able to read and write&#xD;
&#xD;
          -  Both patient and legally responsible caregiver has provided informed consent&#xD;
&#xD;
          -  According to the latest MRI result, periventricular white matter cap or band is less&#xD;
             than 10mm, or the deep white matter hyper-intensity is less than 25 mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have a history of stroke and seizures&#xD;
&#xD;
          -  Subjects who have any illnesses that may disturb the patients completing the trials,&#xD;
             including stroke, Parkinson's disease, type 1 diabetes, uncontrollable high blood&#xD;
             pressure, Huntington's disease, cerebral palsy, liver failure, nephritis,&#xD;
             encephalitis, meningitis, scleroma, seizures and a transient ischemic attack.&#xD;
&#xD;
          -  Subjects who have a History of DSM-IV Axis I disorders&#xD;
&#xD;
          -  Subjects who have neurologic problems on physical examination that cause memory&#xD;
             disturbances&#xD;
&#xD;
          -  Subjects who have Extremely sensitive skin&#xD;
&#xD;
          -  Subjects who have suffered from the cancer in 3 years&#xD;
&#xD;
          -  Subjects who have had a cerebrovascular neurosurgery in medical history&#xD;
&#xD;
          -  Subjects who have dyspnea in sitting position&#xD;
&#xD;
          -  Subjects who have problems with memory, language and problem-solving for 2 hours after&#xD;
             the heart attack.&#xD;
&#xD;
          -  Subjects who have a history of drug or alcohol abuse (in the past 5 years)&#xD;
&#xD;
          -  Subjects who have a history of mental or emotional disorders (in the past 5 years)&#xD;
&#xD;
          -  Subjects who have been lapsed into unconsciousness for an hour because of other&#xD;
             reasons than general anesthesia&#xD;
&#xD;
          -  Subjects who have a history of hospitalization due to head injury&#xD;
&#xD;
          -  Subjects who are unable to read even with glasses&#xD;
&#xD;
          -  Subjects who are unable to understand the conversation due to the hearing defect (even&#xD;
             with the hearing aid)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Duk L. Na, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Duk-Lyul Na, MD, PhD</last_name>
    <phone>+82-2-3410-3594</phone>
    <email>dukna@naver.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Duk L Na, MD, PhD</last_name>
      <phone>+82-2-3410-2594</phone>
      <email>dukna@naver.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>August 31, 2014</last_update_submitted>
  <last_update_submitted_qc>August 31, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Duk Lyul Na</investigator_full_name>
    <investigator_title>Professor of Neurology, Sungkyunkwan University School of Medicine</investigator_title>
  </responsible_party>
  <keyword>Alzheimer's Disease</keyword>
  <keyword>AD</keyword>
  <keyword>tDCS</keyword>
  <keyword>transcranial direct current stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT02227953
org study id: SMC 2014-04-025
nct id: NCT02227953
lead sponsor: 
collaborator: 
has dmc: No
The primary objective of this preliminary study is to investigate whether the transcranial
      direct current stimulation (tDCS) improves the cognitive function in patients with
      Alzheimer's disease
Twenty patients were recruited and randomized to receive either real or sham-tDCS over the
      left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Their legally
      responsible caregivers were provided with mobile tDCS device, and were instructed to use it
      on the patients at home. 30-minute session of the stimulation were applied everyday in the
      morning for 12 weeks. The patients were evaluated at baseline, at week 6 and 12.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in cognitive function
time frame: from baseline to Week 6 and Week 12
description: Measured by ADAS-Cog 11
measure: Change in questionnaire
time frame: from baseline to Week 12
description: Measured by I-PAQ (International Physical Activity Questionnaire), Quality of Life Scale, KDSQ (Korean Dementia Screening Questionnaire), and Prospective and retrospective memory questionnaire
measure: Change in cognitive function
time frame: from baseline to Week 6 and Week 12
description: Measured by Korean version of Montreal Cognitive Assessment (K-MoCA), Korean version of Mini Mental Status Examination (K-MMSE), and Clinical Dementia Rating - Sum of Boxes(CDR-SOB)
measure: Change in Korean version of Geriatric Depression Scale (K-GDS)
time frame: from baseline to Week 6 and Week 12
measure: Change in activities of daily living
time frame: from baseline to Week 12
description: Measured by Korean version of Bayer ADL (K-ADL) and S-IADL (Seoul-Instrumental Activities of Daily Living score)
measure: Change in behavioral symptoms
time frame: from baseline to Week 6 and Week 12
description: Measured by Neuropsychiatric Inventory
measure: Change in Clinician's Interview-Based Impression of Change Plus (CIBIC plus)
time frame: from baseline to Week 12
measure: Change in tDCS feedback
time frame: Week 2, 4, 6 and 12
description: Measured by tDCS feedback questionnaire
arm group label: YBand (YDT-201N)
arm group type: Experimental
description: transcranial Direct Current Stimulation (tDCS) application 7 days a week for 12 weeks (total of 84 applications)
arm group label: sham-Yband (YDT-201N)
arm group type: Sham Comparator
description: sham-tDCS application 7 days a week for 12 weeks (total of 84 applications)
intervention type: Device
intervention name: Yband (YDT-201N)
description: transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 20 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
arm group label: YBand (YDT-201N)
intervention type: Device
intervention name: sham-Yband (YDT-201N)
description: transcranial Direct Current Stimulation (tDCS) 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
arm group label: sham-Yband (YDT-201N)
criteria: 
gender: All
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: No
last name: Duk L. Na, MD, PhD
role: Principal Investigator
affiliation: Samsung Medical Center
last name: Duk-Lyul Na, MD, PhD
phone: +82-2-3410-3594
email: dukna@naver.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Duk Lyul Na
investigator title: Professor of Neurology, Sungkyunkwan University School of Medicine
mesh term: Alzheimer Disease