<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/NCT03227783</url>
  </required_header>
  <id_info>
    <org_study_id>17-0051</org_study_id>
    <nct_id>NCT03227783</nct_id>
  </id_info>
  <brief_title>The Effect of Transcranial Direct Current Stimulation (tDCS) on Depression in PD</brief_title>
  <official_title>The Effect of Transcranial Direct Current Stimulation (tDCS) on Depression in Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inje University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inje 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>
      Depression is common in Parkinson's disease (PD), but the effective treatment is not&#xD;
      established yet. tDCS is a non-invasive brain stimulation to modulate brain function. The&#xD;
      tDCS on the depression in general population were already conducted, but not in PD. This&#xD;
      study is to know whether transcranial direct current stimulation (tDCS) is effective for the&#xD;
      treatment of depression in PD. Participant will be asked to visit three consecutive days for&#xD;
      the non-invasive stimulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 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>Randomized, Parallel, Sham-controlled, single-blinded study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BDI score</measure>
    <time_frame>(1) before the1st visit (within one month) (2) right after the 3rd tDCS (3) within one months after the 3rd tDCS</time_frame>
    <description>The changes of Beck depression inventory after tDCS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HDRS score</measure>
    <time_frame>(1) before the 1st visit (within one month) (2) right after 3rd tDCS, within 24 hours (3) within one months after the 3rd tDCS</time_frame>
    <description>The changes of Hamilton Depression Rating Scale after tDCS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MADRS score</measure>
    <time_frame>(1) before the 1st visit (within one month) (2) right after the 3rd tDCS, within 24 hours (3) within one months after 3rd tDCS</time_frame>
    <description>The changes of Mongomery-Asberg Depression Rating Scale after tDCS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>resting state functional MRI</measure>
    <time_frame>(1) before the 1st visit (within one month) (2) after the 3rd tDCS, within 24 hours (on the same day as the 3rd tDCS)</time_frame>
    <description>The changes of resting state functional MRI after tDCS</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Real tDCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Constant weak electric currents through scalp via two electrodes will be delivered.&#xD;
Current intensity: 2mA, 20min/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>a 1 mA current, for 30 s giving an initial sensation of tDCS while minimizing stimulatory effects&#xD;
Ramp up and ramp down was over 10 s. (Ref. Loo CK et al., Br J Psychiatry 2012;200:52-9)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcranial direct current stimulation (tDCS)</intervention_name>
    <description>tDCS is one of non-invasive brain stimulation. Constant, low current is delivered to the specific brain areas to change brain plasticity.</description>
    <arm_group_label>Real tDCS</arm_group_label>
    <arm_group_label>Sham tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  UK Parkinson's disease brain bank criteria&#xD;
&#xD;
          -  more than 19 years old&#xD;
&#xD;
          -  Able to provide consent for the protocol&#xD;
&#xD;
          -  Depression (based on DSM-IV criteria)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Unpredictable symptom fluctuations&#xD;
&#xD;
          -  Contraindication to tDCS (i) irritations, cuts, lesions in the brain (ii) any&#xD;
             preexisting unstable medical conditions, or conditions that may increase the risk of&#xD;
             stimulation such as uncontrolled epilepsy (iii) history of severe cranial trauma with&#xD;
             alteration of the cranial anatomy or metallic intracranial implants (iv) history of&#xD;
             seizure&#xD;
&#xD;
          -  Subjects without the capacity to give informed consent&#xD;
&#xD;
          -  If participation in the study would, in the opinion of the investigators, cause undue&#xD;
             risk or stress for reasons such as excessive fatigue, general frailty, or excessive&#xD;
             apprehension&#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>Sang Jin Kim, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inje University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sang Jin Kim, MD, PhD</last_name>
    <phone>82-51-890-8954</phone>
    <email>jsk120@hanmail.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Inje university, Busan Paik Hospital</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sang-jin Kim, professor</last_name>
      <phone>82-10-9525-6207</phone>
      <email>jsk120@hanmail.net</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>October 22, 2018</last_update_submitted>
  <last_update_submitted_qc>October 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inje University</investigator_affiliation>
    <investigator_full_name>Sangjin Kim</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>Parkinson Disease</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/NCT03227783
org study id: 17-0051
nct id: NCT03227783
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Depression is common in Parkinson's disease (PD), but the effective treatment is not
      established yet. tDCS is a non-invasive brain stimulation to modulate brain function. The
      tDCS on the depression in general population were already conducted, but not in PD. This
      study is to know whether transcranial direct current stimulation (tDCS) is effective for the
      treatment of depression in PD. Participant will be asked to visit three consecutive days for
      the non-invasive stimulation.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, Parallel, Sham-controlled, single-blinded study
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: BDI score
time frame: (1) before the1st visit (within one month) (2) right after the 3rd tDCS (3) within one months after the 3rd tDCS
description: The changes of Beck depression inventory after tDCS
measure: HDRS score
time frame: (1) before the 1st visit (within one month) (2) right after 3rd tDCS, within 24 hours (3) within one months after the 3rd tDCS
description: The changes of Hamilton Depression Rating Scale after tDCS
measure: MADRS score
time frame: (1) before the 1st visit (within one month) (2) right after the 3rd tDCS, within 24 hours (3) within one months after 3rd tDCS
description: The changes of Mongomery-Asberg Depression Rating Scale after tDCS
measure: resting state functional MRI
time frame: (1) before the 1st visit (within one month) (2) after the 3rd tDCS, within 24 hours (on the same day as the 3rd tDCS)
description: The changes of resting state functional MRI after tDCS
arm group label: Real tDCS
arm group type: Active Comparator
description: Constant weak electric currents through scalp via two electrodes will be delivered.
Current intensity: 2mA, 20min/day
arm group label: Sham tDCS
arm group type: Sham Comparator
description: a 1 mA current, for 30 s giving an initial sensation of tDCS while minimizing stimulatory effects
Ramp up and ramp down was over 10 s. (Ref. Loo CK et al., Br J Psychiatry 2012;200:52-9)
intervention type: Device
intervention name: transcranial direct current stimulation (tDCS)
description: tDCS is one of non-invasive brain stimulation. Constant, low current is delivered to the specific brain areas to change brain plasticity.
arm group label: Real tDCS
arm group label: Sham tDCS
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Sang Jin Kim, MD, PhD
role: Principal Investigator
affiliation: Inje University
last name: Sang Jin Kim, MD, PhD
phone: 82-51-890-8954
email: jsk120@hanmail.net
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Inje University
investigator full name: Sangjin Kim
investigator title: Professor
mesh term: Parkinson Disease
sharing ipd: No