<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/NCT02987361</url>
  </required_header>
  <id_info>
    <org_study_id>CBNUH_MDCTC_2015_tDCS</org_study_id>
    <nct_id>NCT02987361</nct_id>
  </id_info>
  <brief_title>Effect of tDCS on Upper Extremity After Strokes</brief_title>
  <official_title>Effects of Transcranial Direct Current Stimulation on Hemiplegic Upper Extremity Function After Strokes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chonbuk National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pusan National University Yangsan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chonbuk National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that transcranial direct current stimulation (tDCS) can improve&#xD;
      upper limb motor recovery in the sub-acute phase of stroke patients.&#xD;
&#xD;
      This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators hypothesize that transcranial direct current stimulation (tDCS) can improve&#xD;
      upper limb motor recovery in the sub-acute phase of stroke patients.&#xD;
&#xD;
      This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.&#xD;
&#xD;
      Informed consent was obtained from all participants and procedures were conducted according&#xD;
      to the Declaration of Helsinki. The protocol was approved by the Chonbuk National Uni.&#xD;
      Hospital IRB, KOREA.&#xD;
&#xD;
      Seventy-two stroke patients in the sub-acute phase will be recruited in three centers of&#xD;
      neurorehabilitation in republic of Korea.&#xD;
&#xD;
      Patients will be randomly divided to four groups; group1 is anodal stimulation on the&#xD;
      lesioned primary motor cortex, group 2 is cathodal stimulation on the non-lesioned primary&#xD;
      motor cortex, group 3 is dual stimulation such as anodal stimulation on the lesioned side and&#xD;
      cathod stimulation on the non-lesioned side, and group 4 is shame stimulation group.&#xD;
&#xD;
      The stimulation will be conducted 2mA for 20 minute a day, 5 days per weeks, totally 2 weeks.&#xD;
&#xD;
      Fugl-Meyer upper motor score will be measured as a primary outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">August 2018</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Factorial Assignment</intervention_model>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fugl-Meyer Upper Motor Score change</measure>
    <time_frame>before treatment, 48 hours after treatment, 4 weeks after treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Manual Muscle Test (MMT) change</measure>
    <time_frame>before treatment, 48 hours after treatment, 4 weeks after treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion (ROM) change</measure>
    <time_frame>before treatment, 48 hours after treatment, 4 weeks after treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Korean version Modified Bathel Index (KMBI) change</measure>
    <time_frame>before treatment, 48 hours after treatment, 4 weeks after treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>treatment group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>anodal stimulation on the lesioned primary motor cortex DC-STIMULATOR PLUS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>treatment group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cathodal stimulation on the non-lesioned primary motor cortex DC-STIMULATOR PLUS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>treatment group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>dual stimulation such as anodal stimulation on the lesioned side and cathodal stimulation on the non-lesioned side DC-STIMULATOR PLUS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>sham group</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DC-STIMULATOR PLUS</intervention_name>
    <description>2mA for 20minutes a day, 5 days per weeks, totally 2 weeks</description>
    <arm_group_label>sham group</arm_group_label>
    <arm_group_label>treatment group 1</arm_group_label>
    <arm_group_label>treatment group 2</arm_group_label>
    <arm_group_label>treatment group 3</arm_group_label>
    <other_name>tDCS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 20-85&#xD;
&#xD;
          2. Unilateral Stroke patients&#xD;
&#xD;
          3. Inclusion must be in the sub-acute phase defined as within 48hr-4 weeks after stroke&#xD;
&#xD;
          4. Patients who have evoked motor potentials on the first dorsal interossei muscles on&#xD;
             hemiplegic hand&#xD;
&#xD;
          5. The patient has subscribed the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Insert a metal object on the head&#xD;
&#xD;
          2. Convulsive disorders&#xD;
&#xD;
          3. History of brain diseases other than stroke&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Myoung Hwan Ko, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>634-18, Geumam-dong, Deokjin-gu, Jeonju, Jeonbuk, 561-712 Republic of Korea</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Min Jung YU, MANAGER</last_name>
    <phone>82-63-259-3458</phone>
    <phone_ext>3458</phone_ext>
    <email>mjyu@mdctc.or.kr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Myoung Hwan Ko, MD, PhD</last_name>
    <phone>82-63-250-1795</phone>
    <phone_ext>1795</phone_ext>
    <email>mhko@jbnu.ac.kr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kim Yeon Hee</name>
      <address>
        <city>Seoul City</city>
        <state>Ilwon</state>
        <zip>06355</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>AH HE LEE, MS</last_name>
      <phone>82-2-6007-5408</phone>
      <email>ahee.lee@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 31, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>December 7, 2016</last_update_submitted>
  <last_update_submitted_qc>December 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chonbuk National University Hospital</investigator_affiliation>
    <investigator_full_name>Myoung Hwan Ko</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02987361
org study id: CBNUH_MDCTC_2015_tDCS
nct id: NCT02987361
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The investigators hypothesize that transcranial direct current stimulation (tDCS) can improve
      upper limb motor recovery in the sub-acute phase of stroke patients.

      This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.
The investigators hypothesize that transcranial direct current stimulation (tDCS) can improve
      upper limb motor recovery in the sub-acute phase of stroke patients.

      This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.

      Informed consent was obtained from all participants and procedures were conducted according
      to the Declaration of Helsinki. The protocol was approved by the Chonbuk National Uni.
      Hospital IRB, KOREA.

      Seventy-two stroke patients in the sub-acute phase will be recruited in three centers of
      neurorehabilitation in republic of Korea.

      Patients will be randomly divided to four groups; group1 is anodal stimulation on the
      lesioned primary motor cortex, group 2 is cathodal stimulation on the non-lesioned primary
      motor cortex, group 3 is dual stimulation such as anodal stimulation on the lesioned side and
      cathod stimulation on the non-lesioned side, and group 4 is shame stimulation group.

      The stimulation will be conducted 2mA for 20 minute a day, 5 days per weeks, totally 2 weeks.

      Fugl-Meyer upper motor score will be measured as a primary outcome.
allocation: Randomized
intervention model: Factorial Assignment
masking: Double (Participant, Investigator)
measure: Fugl-Meyer Upper Motor Score change
time frame: before treatment, 48 hours after treatment, 4 weeks after treatment
measure: Manual Muscle Test (MMT) change
time frame: before treatment, 48 hours after treatment, 4 weeks after treatment
measure: Range of Motion (ROM) change
time frame: before treatment, 48 hours after treatment, 4 weeks after treatment
measure: Korean version Modified Bathel Index (KMBI) change
time frame: before treatment, 48 hours after treatment, 4 weeks after treatment
arm group label: treatment group 1
arm group type: Experimental
description: anodal stimulation on the lesioned primary motor cortex DC-STIMULATOR PLUS
arm group label: treatment group 2
arm group type: Experimental
description: cathodal stimulation on the non-lesioned primary motor cortex DC-STIMULATOR PLUS
arm group label: treatment group 3
arm group type: Experimental
description: dual stimulation such as anodal stimulation on the lesioned side and cathodal stimulation on the non-lesioned side DC-STIMULATOR PLUS
arm group label: sham group
arm group type: Sham Comparator
description: sham group
intervention type: Device
intervention name: DC-STIMULATOR PLUS
description: 2mA for 20minutes a day, 5 days per weeks, totally 2 weeks
arm group label: sham group
arm group label: treatment group 1
arm group label: treatment group 2
arm group label: treatment group 3
other name: tDCS
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
last name: Myoung Hwan Ko, MD, PhD
role: Principal Investigator
affiliation: 634-18, Geumam-dong, Deokjin-gu, Jeonju, Jeonbuk, 561-712 Republic of Korea
last name: Min Jung YU, MANAGER
phone: 82-63-259-3458
phone ext: 3458
email: mjyu@mdctc.or.kr
last name: Myoung Hwan Ko, MD, PhD
phone: 82-63-250-1795
phone ext: 1795
email: mhko@jbnu.ac.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Chonbuk National University Hospital
investigator full name: Myoung Hwan Ko
investigator title: Professor
mesh term: Stroke
sharing ipd: Undecided