<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/NCT04504422</url>
  </required_header>
  <id_info>
    <org_study_id>PD-tDCS-O</org_study_id>
    <nct_id>NCT04504422</nct_id>
  </id_info>
  <brief_title>tDCS for Dual-task Performance in Patients With PD</brief_title>
  <official_title>Transcranial Direct Current Stimulation to Improve Dual-task Performance in Idiopathic Parkinson's Disease: A Prospective, Single-center, Double-blind, Explorative Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</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 purpose of this study is to investigate the optimal stimulation location of transcranial&#xD;
      direct current stimulation to improve the dual-task performance in patients with Parkinson's&#xD;
      disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parkinson's disease (PD) is a disease caused by dopamine deficiency in the striatum resulting&#xD;
      from the loss of dopaminergic neuronal cells in the cerebral substantia. It is a progressive&#xD;
      neurodegenerative disease characterized by motor symptoms including gait disturbance and&#xD;
      balance instability. In the early stages of Parkinson's disease, dysfunction of the&#xD;
      sensorimotor area of the basal ganglia typically occurs, leading to habitual control hurdles.&#xD;
      Accordingly, cognitive efforts are required to perform habitual tasks such as walking, and&#xD;
      the automaticity of walking is reduced. Walking performance in a dual-task condition has been&#xD;
      used to assess gait automaticity in patients with Parkinson's disease.&#xD;
&#xD;
      Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method&#xD;
      that can be used to change cortical activity. Recently, there has been growing attention on&#xD;
      tDCS as an adjunct tool for rehabilitation. Several tDCS studies in patients with PD have&#xD;
      reported the positive results of tDCS on motor function. However, few studies have reported&#xD;
      the therapeutic effect of tDCS on the dual-task performance in PD. In addition, inconsistent&#xD;
      results have been reported because tDCS protocol has been applied in various way. Therefore,&#xD;
      this study aims to investigate an optimized stimulation site of tDCS that could improve the&#xD;
      dual-task performance in patients with PD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 5, 2020</start_date>
  <completion_date type="Anticipated">October 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 4, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive dual-task interference (%) in Timed-up &amp; go test</measure>
    <time_frame>Immediately after a 20-minute tDCS session</time_frame>
    <description>Percentage of dual-task interference calculated by the difference between dual-task and single-task performance [Percentage of dual-task interference=(Dual-task performance - Single-task performance)/Single-task performance]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical dual-task interference (%) in Timed-up &amp; go test</measure>
    <time_frame>Immediately after a 20-minute tDCS session</time_frame>
    <description>Percentage of dual-task interference calculated by the difference between dual-task and single-task performance [Percentage of dual-task interference=(Dual-task performance - Single-task performance)/Single-task performance]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Timed-up &amp; go test (sec): single task</measure>
    <time_frame>Immediately after a 20-minute tDCS session</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed-up &amp; go test (sec): cognitive dual-task</measure>
    <time_frame>Immediately after a 20-minute tDCS session</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed-up &amp; go test (sec): physical dual-task</measure>
    <time_frame>Immediately after a 20-minute tDCS session</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroop test</measure>
    <time_frame>Immediately after a 20-minute tDCS session</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trail making test</measure>
    <time_frame>Immediately after a 20-minute tDCS session</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digit span test</measure>
    <time_frame>Immediately after a 20-minute tDCS session</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Primary motor cortex</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The anodic electrode is positioned in the primary motor cortex (Cz) and the cathode electrode on the right orbital frontal cortex (Fp2). The current increases to 2.0 mA over a period of 30 seconds, maintains 2.0 mA for 19 minutes, and decreases to 0 mA over 30 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Left dorsolateral prefrontal cortex</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The anodic electrode is positioned in the left dorsolateral prefrontal cortex (F3) and the cathode electrode on the right orbital frontal cortex (Fp2). The current increases to 2.0 mA over a period of 30 seconds, maintains 2.0 mA for 19 minutes, and decreases to 0 mA over 30 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ventromedial prefrontal cortex</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The anodic electrode is positioned in the ventromedial prefrontal cortex (Fpz) and the cathode electrode on the left dorsolateral prefrontal cortex (F4). The current increases to 2.0 mA over a period of 30 seconds, maintains 2.0 mA for 19 minutes, and decreases to 0 mA over 30 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The anodic electrode is positioned in the primary motor cortex (Cz) and the cathode electrode on the right orbital frontal cortex (Fp2). The current increases to 2.0 mA during first 30 seconds, decreases to 0 mA over 30 seconds, and then stops supplying for 19 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcranial Direct Current Stimulation (tDCS)</intervention_name>
    <description>tDCS was applied for 20 minutes through two saline-soaked sponge electrodes (diameter 6cm) using the YMS-201B (Ybrain Inc, South Korea).</description>
    <arm_group_label>Left dorsolateral prefrontal cortex</arm_group_label>
    <arm_group_label>Primary motor cortex</arm_group_label>
    <arm_group_label>Sham stimulation</arm_group_label>
    <arm_group_label>Ventromedial prefrontal cortex</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinically diagnosed as idiopathic Parkinson's disease&#xD;
&#xD;
          -  modified Hoehn &amp; Yahr stage 2, 2.5, or 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of seizure&#xD;
&#xD;
          -  Metallic implants, such as cardiac pacemaker or an artificial cochlea&#xD;
&#xD;
          -  Patients with inflammation, burns, or wounds in the stimulation area&#xD;
&#xD;
          -  Parkinson's disease dementia; cut-off is &lt; 7 of Korean-Montreal Cognitive Assessment&#xD;
             for illiterate patients, &lt; 13 for those educated for 0.5-3 years, &lt; 16 for 4-6 years&#xD;
             of education, &lt; 19 for 7-9 years of education, and &lt; 20 for 10 or more years of&#xD;
             education.&#xD;
&#xD;
          -  Severe dyskinesia or severe on-off phenomenon&#xD;
&#xD;
          -  Plan to adjust medication at the time of screening&#xD;
&#xD;
          -  Sensory abnormalities of the lower extremities, other neurological or orthopedic&#xD;
             disease affecting lower extremities, or severe cardiovascular diseases&#xD;
&#xD;
          -  Vestibular disease or paroxysmal vertigo&#xD;
&#xD;
          -  Pregnant or lactating patients&#xD;
&#xD;
          -  Other comorbidities that make it difficult to participate in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Han Gil Seo, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Han Gil Seo, MD, PhD</last_name>
    <phone>82-2-2072-1659</phone>
    <email>hgseo80@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Han Gil Seo, MD</last_name>
      <phone>82-2-2072-1659</phone>
      <email>hgseo80@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>April 10, 2023</last_update_submitted>
  <last_update_submitted_qc>April 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Han Gil Seo</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Parkinson Disease</keyword>
  <keyword>transcranial direct current stimulation</keyword>
  <keyword>dual-task performance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson 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/NCT04504422
org study id: PD-tDCS-O
nct id: NCT04504422
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the optimal stimulation location of transcranial
      direct current stimulation to improve the dual-task performance in patients with Parkinson's
      disease.
Parkinson's disease (PD) is a disease caused by dopamine deficiency in the striatum resulting
      from the loss of dopaminergic neuronal cells in the cerebral substantia. It is a progressive
      neurodegenerative disease characterized by motor symptoms including gait disturbance and
      balance instability. In the early stages of Parkinson's disease, dysfunction of the
      sensorimotor area of the basal ganglia typically occurs, leading to habitual control hurdles.
      Accordingly, cognitive efforts are required to perform habitual tasks such as walking, and
      the automaticity of walking is reduced. Walking performance in a dual-task condition has been
      used to assess gait automaticity in patients with Parkinson's disease.

      Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method
      that can be used to change cortical activity. Recently, there has been growing attention on
      tDCS as an adjunct tool for rehabilitation. Several tDCS studies in patients with PD have
      reported the positive results of tDCS on motor function. However, few studies have reported
      the therapeutic effect of tDCS on the dual-task performance in PD. In addition, inconsistent
      results have been reported because tDCS protocol has been applied in various way. Therefore,
      this study aims to investigate an optimized stimulation site of tDCS that could improve the
      dual-task performance in patients with PD.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Cognitive dual-task interference (%) in Timed-up & go test
time frame: Immediately after a 20-minute tDCS session
description: Percentage of dual-task interference calculated by the difference between dual-task and single-task performance [Percentage of dual-task interference=(Dual-task performance - Single-task performance)/Single-task performance]
measure: Physical dual-task interference (%) in Timed-up & go test
time frame: Immediately after a 20-minute tDCS session
description: Percentage of dual-task interference calculated by the difference between dual-task and single-task performance [Percentage of dual-task interference=(Dual-task performance - Single-task performance)/Single-task performance]
measure: Timed-up & go test (sec): single task
time frame: Immediately after a 20-minute tDCS session
measure: Timed-up & go test (sec): cognitive dual-task
time frame: Immediately after a 20-minute tDCS session
measure: Timed-up & go test (sec): physical dual-task
time frame: Immediately after a 20-minute tDCS session
measure: Stroop test
time frame: Immediately after a 20-minute tDCS session
measure: Trail making test
time frame: Immediately after a 20-minute tDCS session
measure: Digit span test
time frame: Immediately after a 20-minute tDCS session
arm group label: Primary motor cortex
arm group type: Experimental
description: The anodic electrode is positioned in the primary motor cortex (Cz) and the cathode electrode on the right orbital frontal cortex (Fp2). The current increases to 2.0 mA over a period of 30 seconds, maintains 2.0 mA for 19 minutes, and decreases to 0 mA over 30 seconds.
arm group label: Left dorsolateral prefrontal cortex
arm group type: Experimental
description: The anodic electrode is positioned in the left dorsolateral prefrontal cortex (F3) and the cathode electrode on the right orbital frontal cortex (Fp2). The current increases to 2.0 mA over a period of 30 seconds, maintains 2.0 mA for 19 minutes, and decreases to 0 mA over 30 seconds.
arm group label: Ventromedial prefrontal cortex
arm group type: Experimental
description: The anodic electrode is positioned in the ventromedial prefrontal cortex (Fpz) and the cathode electrode on the left dorsolateral prefrontal cortex (F4). The current increases to 2.0 mA over a period of 30 seconds, maintains 2.0 mA for 19 minutes, and decreases to 0 mA over 30 seconds.
arm group label: Sham stimulation
arm group type: Sham Comparator
description: The anodic electrode is positioned in the primary motor cortex (Cz) and the cathode electrode on the right orbital frontal cortex (Fp2). The current increases to 2.0 mA during first 30 seconds, decreases to 0 mA over 30 seconds, and then stops supplying for 19 minutes.
intervention type: Device
intervention name: transcranial Direct Current Stimulation (tDCS)
description: tDCS was applied for 20 minutes through two saline-soaked sponge electrodes (diameter 6cm) using the YMS-201B (Ybrain Inc, South Korea).
arm group label: Left dorsolateral prefrontal cortex
arm group label: Primary motor cortex
arm group label: Sham stimulation
arm group label: Ventromedial prefrontal cortex
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Han Gil Seo, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
last name: Han Gil Seo, MD, PhD
phone: 82-2-2072-1659
email: hgseo80@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Han Gil Seo
investigator title: Associate Professor
mesh term: Parkinson Disease