<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/NCT03025334</url>
  </required_header>
  <id_info>
    <org_study_id>B2016:052</org_study_id>
    <nct_id>NCT03025334</nct_id>
  </id_info>
  <brief_title>tDCS on Parkinson's Disease Cognition</brief_title>
  <acronym>tDCS-PD-fMRI</acronym>
  <official_title>Transcranial Direct Current Stimulation Treatment of Cognitive Dysfunction in Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Parkinson Society Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Manitoba</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Parkinson's disease (PD) has been classically regarded as a &quot;movement disorder&quot;, so earlier&#xD;
      work has focused on treating motor symptoms only. As PD patients now have longer life&#xD;
      expectancy, the relatively slowly progressing cognitive deficits (compared to their motor&#xD;
      deficits) have become one of the major challenges. Approximately 80% of PD patients&#xD;
      eventually become demented. Therefore cognitive dysfunction is one of the most significant&#xD;
      factors affecting the quality of life of patients with PD. While dementia in Parkinson's&#xD;
      disease is routinely treated by cholinesterase inhibitors (e.g., donepezil and rivastigmine),&#xD;
      their efficacy on mild cognitive impairment found in non-demented PD is questionable.&#xD;
      Alternative approaches have been proposed including transcranial direct current stimulation&#xD;
      (tDCS) but no consensus has been reached. This can be attributed mainly to: (1) imprecise&#xD;
      knowledge of the underlying functional circuitry mediating this disease manifestation and (2)&#xD;
      inter-individual variability. Here, the investigators will utilize a novel personalized&#xD;
      network analysis approach to elucidate on the underlying mechanisms of the effect of tDCS on&#xD;
      cognitive dysfunction in non-demented PD patients.&#xD;
&#xD;
      It has been well documented that the caudate nucleus plays an important role in cognitive&#xD;
      dysfunction found in PD. In the investigators' preliminary resting-state functional magnetic&#xD;
      resonance imaging (fMRI) study, they have shown that the connectivity of the right caudate&#xD;
      nucleus is correlated to cognitive status of PD patients measured by the Montreal Cognitive&#xD;
      Assessment (MoCA). The investigators hypothesize that tDCS on the left and/or right&#xD;
      dorsolateral prefrontal cortex may restore the functional connectivity of the right caudate&#xD;
      nucleus which may in turn improve patients' cognitive performance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 22, 2017</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">August 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cognitive performance in neuropsychological tests</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>sham tDCS (30sec ramp-up and 3sec ramp-down)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Real tDCS right</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Real anodal tDCS (right DLPFC)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High-definition transcranial direct current stimulation</intervention_name>
    <description>brain stimulation to increase neuronal excitability in the targeted regions</description>
    <arm_group_label>Real tDCS right</arm_group_label>
    <arm_group_label>Sham tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must meet diagnostic criteria for idiopathic Parkinson's disease, defined as&#xD;
             the presence of two or more of the cardinal clinical features of PD in the absence of&#xD;
             known causes of parkinsonism such as encephalitis or neuroleptic treatment&#xD;
&#xD;
          -  Ability to provide written informed consent&#xD;
&#xD;
          -  defined by the Diagnostic and Statistical Manual of Mental Disorders; DSM-5)&#xD;
&#xD;
          -  Age &gt; 40&#xD;
&#xD;
          -  fluent in English.&#xD;
&#xD;
          -  Patients' cognitive statuses will be evaluated by the participating neuropsychiatrist&#xD;
             or a trained psychiatry or neurology resident.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with dementia (defined as a Montreal Cognitive Assessment score &lt; 18)&#xD;
&#xD;
          -  Atypical parkinsonian features including myoclonus, apraxia, oculomotor abnormalities,&#xD;
             ataxia, sensory loss, or pyramidal signs.&#xD;
&#xD;
          -  Abnormal MRI&#xD;
&#xD;
          -  metal implants or a cardiac pacemaker&#xD;
&#xD;
          -  Pregnant or breastfeeding women (female subjects of child bearing potential will be&#xD;
             screened for pregnancy before MRI imaging).&#xD;
&#xD;
          -  severe dyskinesia that may interfere with the quality of the scan (e.g., dyskinesia&#xD;
             involving head movement).&#xD;
&#xD;
          -  severe hypertension.&#xD;
&#xD;
          -  cardiovascular disease.&#xD;
&#xD;
          -  Patients with a history of seizure, stroke, moderate to severe head injury, high&#xD;
             intracranial pressure, severe headaches, or presence of other neurologic disease that&#xD;
             may be associated with an altered seizure threshold; or concurrent medication use,&#xD;
             such as tricyclic antidepressants, neuroleptic medications, or other drugs that are&#xD;
             known to lower seizure threshold&#xD;
&#xD;
          -  secondary conditions that may significantly alter electrolyte balance or lower seizure&#xD;
             threshold.&#xD;
&#xD;
          -  Family history of epilepsy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ji Hyun Ko, PhD</last_name>
    <phone>204-318-2566</phone>
    <email>ji.ko@umanitoba.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 0J9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ji Hyun Ko, PhD</last_name>
      <phone>204-318-2566</phone>
      <email>ji.ko@umanitoba.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manitoba</investigator_affiliation>
    <investigator_full_name>Ji Hyun Ko, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Cognitive Dysfunction</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/NCT03025334
org study id: B2016:052
nct id: NCT03025334
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Parkinson's disease (PD) has been classically regarded as a "movement disorder", so earlier
      work has focused on treating motor symptoms only. As PD patients now have longer life
      expectancy, the relatively slowly progressing cognitive deficits (compared to their motor
      deficits) have become one of the major challenges. Approximately 80% of PD patients
      eventually become demented. Therefore cognitive dysfunction is one of the most significant
      factors affecting the quality of life of patients with PD. While dementia in Parkinson's
      disease is routinely treated by cholinesterase inhibitors (e.g., donepezil and rivastigmine),
      their efficacy on mild cognitive impairment found in non-demented PD is questionable.
      Alternative approaches have been proposed including transcranial direct current stimulation
      (tDCS) but no consensus has been reached. This can be attributed mainly to: (1) imprecise
      knowledge of the underlying functional circuitry mediating this disease manifestation and (2)
      inter-individual variability. Here, the investigators will utilize a novel personalized
      network analysis approach to elucidate on the underlying mechanisms of the effect of tDCS on
      cognitive dysfunction in non-demented PD patients.

      It has been well documented that the caudate nucleus plays an important role in cognitive
      dysfunction found in PD. In the investigators' preliminary resting-state functional magnetic
      resonance imaging (fMRI) study, they have shown that the connectivity of the right caudate
      nucleus is correlated to cognitive status of PD patients measured by the Montreal Cognitive
      Assessment (MoCA). The investigators hypothesize that tDCS on the left and/or right
      dorsolateral prefrontal cortex may restore the functional connectivity of the right caudate
      nucleus which may in turn improve patients' cognitive performance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: cognitive performance in neuropsychological tests
time frame: 1 month
arm group label: Sham tDCS
arm group type: Sham Comparator
description: sham tDCS (30sec ramp-up and 3sec ramp-down)
arm group label: Real tDCS right
arm group type: Active Comparator
description: Real anodal tDCS (right DLPFC)
intervention type: Device
intervention name: High-definition transcranial direct current stimulation
description: brain stimulation to increase neuronal excitability in the targeted regions
arm group label: Real tDCS right
arm group label: Sham tDCS
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Ji Hyun Ko, PhD
phone: 204-318-2566
email: ji.ko@umanitoba.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Manitoba
investigator full name: Ji Hyun Ko, PhD
investigator title: Associate Professor
mesh term: Parkinson Disease
mesh term: Cognitive Dysfunction